Trial Outcomes & Findings for Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT01565668)

NCT ID: NCT01565668

Last Updated: 2019-12-27

Results Overview

CRc is defined as Complete remission (CR) + Complete remission with incomplete platelet recovery (CRp) + Complete remission with incomplete hematological recovery (CRi). * Participants with CR must have normal hematopoietic cells and achieved a morphologic leukemia-free state (\<5% bone marrow blasts in bone marrow, no blasts with Auer rods and no persistence of extramedullary disease) and must have had an absolute neutrophil count (ANC) ≥1 × 10\^9/L and platelet count ≥100 × 10\^9/L and were red blood cell (RBC) and platelet transfusion independent. Blasts in the peripheral blood was to be ≤1% (if blood sample was available). * Participants with CRp must have achieved CR except for incomplete platelet recovery (\< 100 ×10\^9/L). * Participants with CRi must have fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia \<1 × 10\^9/L with or without complete platelet recovery. RBC and platelet transfusion independence were not required.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 76 participants
• Primary outcome timeframe: At end of Cycle 2 (after two complete 28-day cycles post treatment)
• Results posted on: 2019-12-27

Participant Flow

A total of 76 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study (intent-to-treat population). Participants were enrolled at 22 clinic sites in North America and Europe (14 sites in the United States, 6 in France, 1 in Italy, and 1 in the United Kingdom).

Participants were randomized (1:1) to receive 30 or 60 mg/day quizartinib. These doses were selected based on evidence of efficacy and safety observed in studies AC220-001 and AC220-002, and preclinical data.Two participants who were randomized to quizartinib (60 mg/day) did not receive study drug and are not included in the safety data.

Participant milestones

Measure	Quizartinib 30 mg Participants randomized to receive 30 mg quizartinib once daily.	Quizartinib 60 mg Participants randomized to receive 60 mg quizartinib once daily.
Overall Study STARTED	38	38
Overall Study Completed Treatment Per Protocol	0	0
Overall Study Started 30-day Follow-up	37	37
Overall Study Completed 30-day Follow-up	11	5
Overall Study Started Long-term Follow-up	36	33
Overall Study Completed Long-term Follow-up	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	38	38

Reasons for withdrawal

Measure	Quizartinib 30 mg Participants randomized to receive 30 mg quizartinib once daily.	Quizartinib 60 mg Participants randomized to receive 60 mg quizartinib once daily.
Overall Study Death	2	1
Overall Study Lack of Efficacy	4	2
Overall Study Participant went on Hospice Care	1	0
Overall Study Adverse Event	6	1
Overall Study Randomized, but never received drug	0	2
Overall Study Progressive disease	13	14
Overall Study Withdrawal by Subject	1	3
Overall Study HSCT Transplant	11	15

Baseline Characteristics

Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Baseline characteristics by cohort

Measure	Quizartinib 30 mg n=38 Participants Participants randomized to receive 30 mg quizartinib once daily.	Quizartinib 60 mg n=38 Participants Participants were randomized to receive 60 mg quizartinib once daily.	Total n=76 Participants Total of all reporting groups
Age, Continuous	56.5 years n=5 Participants	53.0 years n=7 Participants	54.5 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	22 Participants n=7 Participants	44 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	1 Participants n=5 Participants	2 Participants n=7 Participants	3 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	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	30 Participants n=7 Participants	59 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	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants
Region of Enrollment Italy	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment United Kingdom	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment France	7 participants n=5 Participants	5 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: At end of Cycle 2 (after two complete 28-day cycles post treatment)

Population: Composite complete remission was assessed in the intent-to-treat (ITT) analysis set.

CRc is defined as Complete remission (CR) + Complete remission with incomplete platelet recovery (CRp) + Complete remission with incomplete hematological recovery (CRi).

• Participants with CR must have normal hematopoietic cells and achieved a morphologic leukemia-free state (<5% bone marrow blasts in bone marrow, no blasts with Auer rods and no persistence of extramedullary disease) and must have had an absolute neutrophil count (ANC) ≥1 × 10^9/L and platelet count ≥100 × 10^9/L and were red blood cell (RBC) and platelet transfusion independent. Blasts in the peripheral blood was to be ≤1% (if blood sample was available).
• Participants with CRp must have achieved CR except for incomplete platelet recovery (< 100 ×10^9/L).
• Participants with CRi must have fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia <1 × 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence were not required.

Outcome measures

Measure	Quizartinib 30 mg n=38 Participants Participants randomized to receive 30 mg quizartinib once daily.	Quizartinib 60 mg n=38 Participants Participants randomized to receive 60 mg quizartinib once daily.
Number of Participants Who Achieved Composite Complete Response (CRc) (Intent-to-Treat Population)	18 Participants	18 Participants

SECONDARY outcome

Timeframe: At end of treatment visit (approximately 3 years post treatment)

Population: Complete remission was assessed in the intent-to-treat (ITT) analysis set.

Participant must have bone marrow regenerating normal hematopoietic cells and achieve a morphologic leukemia-free state (< 5% bone marrow blasts in bone marrow, no blasts with Auer rods and no persistence of extramedullary disease) and must have an absolute neutrophil count (ANC) ≥ 1x10^9/L and platelet count ≥ 100 x 10^9/L and they will be red blood cell (RBC) and platelet transfusion independent (defined as 4 weeks without RBC transfusions and 1 week without platelet transfusion).

Outcome measures

Measure	Quizartinib 30 mg n=38 Participants Participants randomized to receive 30 mg quizartinib once daily.	Quizartinib 60 mg n=38 Participants Participants randomized to receive 60 mg quizartinib once daily.
Number of Participants Who Achieved Complete Remission (CR) (Intent-to-Treat Population)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Evaluated at end of study, up to 6 months (approximately 3 years post treatment)

Population: OS was assessed in the intent-to-treat (ITT) analysis set.

OS was defined as the time from the date of randomization until the date of death from any cause.

Outcome measures

Measure	Quizartinib 30 mg n=38 Participants Participants randomized to receive 30 mg quizartinib once daily.	Quizartinib 60 mg n=38 Participants Participants randomized to receive 60 mg quizartinib once daily.
Overall Survival (OS) After Approximately 3 Years (Intent-to-Treat Population)	20.9 weeks Interval 17.7 to 25.3	27.3 weeks Interval 17.3 to 34.9

SECONDARY outcome

Timeframe: Evaluated at end of study, up to 6 months (approximately 3 years post treatment)

Population: EFS was assessed in the intent-to-treat (ITT) analysis set.

EFS was defined as the time from the date of randomization until the date of documented relapse or death.

Outcome measures

Measure	Quizartinib 30 mg n=38 Participants Participants randomized to receive 30 mg quizartinib once daily.	Quizartinib 60 mg n=38 Participants Participants randomized to receive 60 mg quizartinib once daily.
Event Free Survival (EFS) After Approximately 3 Years (Intent-to-Treat Population)	12.0 weeks Interval 8.3 to 16.1	13.7 weeks Interval 9.7 to 26.1

SECONDARY outcome

Timeframe: Evaluated at end of study, up to 6 months (approximately 3 years post treatment)

Population: LFS was assessed in the intent-to-treat (ITT) analysis set.

LFS was defined as the time from the date of first CRc until the date of documented relapse or death for participants who achieved CRc.

Outcome measures

Measure	Quizartinib 30 mg n=18 Participants Participants randomized to receive 30 mg quizartinib once daily.	Quizartinib 60 mg n=18 Participants Participants randomized to receive 60 mg quizartinib once daily.
Leukemia Free Survival (LFS) After Approximately 3 Years (Intent-to-Treat Population)	4.1 weeks Interval 2.1 to 9.7	9.1 weeks Interval 4.0 to 22.3

SECONDARY outcome

Timeframe: Evaluated at end of study, up to 6 months (approximately 3 years post treatment)

Population: Duration of remission was assessed in the intent-to-treat (ITT) analysis set.

Duration of remission was defined as the time from first documented remission until documented relapse. CRc was defined as composite complete remission and CRi was defined as complete remission with incomplete hematological recovery.

Outcome measures

Measure	Quizartinib 30 mg n=38 Participants Participants randomized to receive 30 mg quizartinib once daily.	Quizartinib 60 mg n=38 Participants Participants randomized to receive 60 mg quizartinib once daily.
Duration of Remission After Approximately 3 Years (Intent-to-Treat Population) CRc	4.2 weeks Interval 2.1 to 9.7	9.1 weeks Interval 4.1 to 22.3
Duration of Remission After Approximately 3 Years (Intent-to-Treat Population) CRi	4.1 weeks Interval 2.1 to 9.7	20.0 weeks Interval 4.0 to 75.6

SECONDARY outcome

Timeframe: Evaluated at end of study, up to 6 months (approximately 3 years post treatment)

Population: Time to CRc was assessed in the intent-to-treat (ITT) analysis set.

Time to CRc was defined as the time from the date of randomization until the first disease assessment of CRc. Time to CRc was only evaluated in participants who achieved CRc.

Outcome measures

Measure	Quizartinib 30 mg n=18 Participants Participants randomized to receive 30 mg quizartinib once daily.	Quizartinib 60 mg n=18 Participants Participants randomized to receive 60 mg quizartinib once daily.
Time to Composite Complete Remission (CRc) in Participants Who Achieved CRc After Approximately 3 Years (Intent-to-Treat Population)	4.4 weeks Interval 4.1 to 7.7	4.6 weeks Interval 4.1 to 8.0

SECONDARY outcome

Timeframe: Evaluated at end of study, up to 6 months (approximately 3 years post treatment)

Population: Transplantation rate was assessed in the intent-to-treat (ITT) analysis set.

Transplantation rate was defined as the percentage of participants who underwent HSCT directly after treatment with quizartinib (no other intervening acute myeloid leukemia therapies other than conditioning regimens for the HSCT).

Outcome measures

Measure	Quizartinib 30 mg n=38 Participants Participants randomized to receive 30 mg quizartinib once daily.	Quizartinib 60 mg n=38 Participants Participants randomized to receive 60 mg quizartinib once daily.
Percentage of Participants Undergoing Hematopoietic Stem Cell Transplantation (HSCT) After Approximately 3 Years (Intent-to-Treat Population) Yes	31.6 percentage of participants	42.1 percentage of participants
Percentage of Participants Undergoing Hematopoietic Stem Cell Transplantation (HSCT) After Approximately 3 Years (Intent-to-Treat Population) No	68.4 percentage of participants	55.3 percentage of participants
Percentage of Participants Undergoing Hematopoietic Stem Cell Transplantation (HSCT) After Approximately 3 Years (Intent-to-Treat Population) Unknown	0 percentage of participants	2.6 percentage of participants

SECONDARY outcome

Timeframe: Evaluated at end of study, up to 6 months (approximately 3 years post treatment)

Population: QTcF prolongation was assessed in the Safety Analysis Set.

QT interval corrected for heart rate using Fridericia's formula (QTcF) grading was to be done according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and the definition of Grade 2 or higher prolongation is QTcF more than 480 msec.

Outcome measures

Measure	Quizartinib 30 mg n=38 Participants Participants randomized to receive 30 mg quizartinib once daily.	Quizartinib 60 mg n=36 Participants Participants randomized to receive 60 mg quizartinib once daily.
Percentage of Participants With Grade 2 or Higher QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Prolongation After Receiving Quizartinib (Safety Analysis Set) Max on study; <450 msec	47.4 percentage of participants	36.1 percentage of participants
Percentage of Participants With Grade 2 or Higher QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Prolongation After Receiving Quizartinib (Safety Analysis Set) Max on study; ≥450 msec and ≤480 msec	42.1 percentage of participants	47.2 percentage of participants
Percentage of Participants With Grade 2 or Higher QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Prolongation After Receiving Quizartinib (Safety Analysis Set) Max on study; >480 msec and ≤500 msec	5.3 percentage of participants	13.9 percentage of participants
Percentage of Participants With Grade 2 or Higher QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Prolongation After Receiving Quizartinib (Safety Analysis Set) Max on study; >500 msec	5.3 percentage of participants	2.8 percentage of participants
Percentage of Participants With Grade 2 or Higher QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Prolongation After Receiving Quizartinib (Safety Analysis Set) Max change from baseline; ≤30 msec	47.4 percentage of participants	38.9 percentage of participants
Percentage of Participants With Grade 2 or Higher QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Prolongation After Receiving Quizartinib (Safety Analysis Set) Max change from baseline; >30 msec and ≤60 msec	47.4 percentage of participants	41.7 percentage of participants
Percentage of Participants With Grade 2 or Higher QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Prolongation After Receiving Quizartinib (Safety Analysis Set) Max change from baseline; >60 msec	5.3 percentage of participants	19.4 percentage of participants

Adverse Events

Quizartinib 30 mg

Serious events: 25 serious events

Other events: 37 other events

Deaths: 9 deaths

Quizartinib 60 mg

Serious events: 23 serious events

Other events: 36 other events

Deaths: 13 deaths

Serious adverse events

Measure	Quizartinib 30 mg n=38 participants at risk Participants randomized to receive 30 mg quizartinib once daily.	Quizartinib 60 mg n=36 participants at risk Participants randomized to receive 60 mg quizartinib once daily.
Blood and lymphatic system disorders Febrile neutropenia	18.4% 7/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	16.7% 6/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Blood and lymphatic system disorders Thrombocytopenia	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Cardiac disorders Pericardial effusion	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Nausea	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Vomiting	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Pyrexia	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	13.9% 5/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Multi-organ failure	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Pneumonia	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	16.7% 6/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Cellulitis	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Septic shock	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Device-related infection	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Periorbital cellulitis	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Urinary tract infection bacterial	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Investigations Alanine aminotransferase increased	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Investigations Electrocardiogram QT prolonged	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukemia	13.2% 5/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	19.4% 7/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Renal and urinary disorders Renal failure acute	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Renal and urinary disorders Urinary rentention	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Blood and lymphatic system disorders Anemia	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Blood and lymphatic system disorders Leukocytosis	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Blood and lymphatic system disorders Pancytopenia	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Cardiac disorders Atrial fibrillation	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Cardiac disorders Bradycardia	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Cardiac disorders Pericarditis	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Cardiac disorders Tachycardia	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Cardiac disorders Ventricular tachycardia	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Diarrhea	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Gastrointestinal hemorrhage	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Abdominal pain	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Cecitis	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Gastric ulcer	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Hematemesis	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Intestinal infarction	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Melaena	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Oesophageal ulcer	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Rectal hemorrhage	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Hyperthermia	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Disease progression	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Non-cardiac chest pain	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Clostridium difficile colitis	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Sepsis	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Abscess intestinal	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Arthritis infective	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Bacteremia	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Bronchitis fungal	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Candidiasis	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Catheter-site infection	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Clostridium difficile sepsis	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Diverticulitis	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Enteritis infectious	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Escherichia sepsis	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Klebsiella bacteremia	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Lung infection	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Neutropenic sepsis	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Pneumonia fungal	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Sinusitis	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Skin infection	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Streptococcal infection	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Urinary tract infection	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Viral infection	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Injury, poisoning and procedural complications Accidental overdose	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Investigations Aspartate aminotransferase increased	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Investigations Blood bilirubin increased	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Investigations Medical observation	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Musculoskeletal and connective tissue disorders Arthralgia	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Nervous system disorders Convulsion	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Nervous system disorders Ischaemic stroke	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Nervous system disorders Syncope	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Psychiatric disorders Mental status changes	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Renal and urinary disorders Hematuria	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Hemoptysis	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Cough	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Skin and subcutaneous tissue disorders Erythema	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Vascular disorders Hypotension	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Vascular disorders Shock hemorrhagic	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Vascular disorders Venoocclusive disease	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.

Other adverse events

Measure	Quizartinib 30 mg n=38 participants at risk Participants randomized to receive 30 mg quizartinib once daily.	Quizartinib 60 mg n=36 participants at risk Participants randomized to receive 60 mg quizartinib once daily.
Blood and lymphatic system disorders Anemia	47.4% 18/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	25.0% 9/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Nausea	26.3% 10/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	47.2% 17/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Blood and lymphatic system disorders Febrile neutropenia	31.6% 12/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	36.1% 13/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Pyrexia	28.9% 11/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	38.9% 14/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Vomiting	28.9% 11/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	36.1% 13/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Diarrhea	26.3% 10/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	36.1% 13/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Fatigue	34.2% 13/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	22.2% 8/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Cough	23.7% 9/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	25.0% 9/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Abdominal pain	15.8% 6/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	30.6% 11/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Blood and lymphatic system disorders Thrombocytopenia	26.3% 10/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	19.4% 7/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Metabolism and nutrition disorders Hypokalemia	23.7% 9/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	16.7% 6/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	21.1% 8/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	16.7% 6/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Oedema peripheral	21.1% 8/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	16.7% 6/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Nervous system disorders Headache	10.5% 4/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	25.0% 9/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukemia	13.2% 5/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	19.4% 7/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Metabolism and nutrition disorders Decreased appetite	13.2% 5/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	16.7% 6/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Mucosal inflammation	15.8% 6/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	13.9% 5/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	13.2% 5/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	16.7% 6/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Pneumonia	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	22.2% 8/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Epistaxis	15.8% 6/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	11.1% 4/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Vascular disorders Hypotension	15.8% 6/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	11.1% 4/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Cardiac disorders Tachycardia	10.5% 4/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	16.7% 6/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Constipation	15.8% 6/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	8.3% 3/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Metabolism and nutrition disorders Hypomagnesemia	13.2% 5/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	11.1% 4/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Investigations Alanine aminotransferase increased	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	13.9% 5/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Musculoskeletal and connective tissue disorders Back pain	13.2% 5/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	8.3% 3/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Chills	13.2% 5/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	8.3% 3/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Nervous system disorders Dysgeusia	15.8% 6/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Dyspepsia	15.8% 6/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Investigations Electrocardiogram QT prolonged	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	16.7% 6/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	16.7% 6/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Investigations Blood bilirubin increased	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	11.1% 4/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Nervous system disorders Dizziness	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	11.1% 4/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Metabolism and nutrition disorders Hyperglycemia	10.5% 4/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	8.3% 3/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Psychiatric disorders Insomnia	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	13.9% 5/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	11.1% 4/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Psychiatric disorders Anxiety	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	13.9% 5/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Musculoskeletal and connective tissue disorders Arthralgia	10.5% 4/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Investigations Aspartate aminotransferase increased	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	11.1% 4/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Metabolism and nutrition disorders Hyperphosphatemia	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	16.7% 6/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Metabolism and nutrition disorders Hypoalbuminemia	10.5% 4/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Metabolism and nutrition disorders Hypocalcemia	10.5% 4/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Metabolism and nutrition disorders Hyponatremia	10.5% 4/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Metabolism and nutrition disorders Hypophosphatemia	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	13.9% 5/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Blood and lymphatic system disorders Neutropenia	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	13.9% 5/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Pain	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	11.1% 4/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Musculoskeletal and connective tissue disorders Pain in extremity	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	8.3% 3/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Asthenia	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Skin and subcutaneous tissue disorders Erythema	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	11.1% 4/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Hemorrhoids	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	8.3% 3/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Musculoskeletal and connective tissue disorders Myalgia	10.5% 4/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Musculoskeletal and connective tissue disorders Neck pain	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	11.1% 4/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Non-cardiac chest pain	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	13.9% 5/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Cardiac disorders Pericardial effusion	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Skin and subcutaneous tissue disorders Skin lesion	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Cellulitis	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	8.3% 3/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Clostridial infection	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	8.3% 3/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Injury, poisoning and procedural complications Contusion	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Skin and subcutaneous tissue disorders Dry skin	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Vascular disorders Hypertension	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	8.3% 3/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Blood and lymphatic system disorders Leukocytosis	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Musculoskeletal and connective tissue disorders Muscular weakness	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Oedema	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	8.3% 3/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Nervous system disorders Paresthesia	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	8.3% 3/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Skin and subcutaneous tissue disorders Petechiae	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	8.3% 3/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Investigations Platelet count decreased	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Skin and subcutaneous tissue disorders Rash	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	8.3% 3/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Eye disorders Vision blurred	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Catheter site erythema	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Catheter site pain	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Chest discomfort	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Clostridium difficile colitis	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Psychiatric disorders Confusional state	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Injury, poisoning and procedural complications Fall	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Gastrointestinal hemorrhage	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Hematemesis	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Renal and urinary disorders Hematuria	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Hemoptysis	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Herpes simplex	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Melaena	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Proctalgia	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Productive cough	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Skin and subcutaneous tissue disorders Pruritus	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Skin and subcutaneous tissue disorders Rash erythematous	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Renal and urinary disorders Renal failure acute	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	8.3% 3/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Rhinitis	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	7.9% 3/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Septic shock	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Cardiac disorders Sinus tachycardia	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Toothache	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Injury, poisoning and procedural complications Transfusion reaction	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Nervous system disorders Tremor	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Renal and urinary disorders Urinary retention	2.6% 1/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Investigations White blood cell count decreased	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	2.8% 1/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Nervous system disorders Ageusia	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Bacteremia	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Investigations Blood alkaline phophatase increased	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Bronchitis	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Device related infection	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Eructation	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Escherichia sepsis	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Psychiatric disorders Hallucination, visual	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Metabolism and nutrition disorders Hyperkalemia	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Malaise	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Gastrointestinal disorders Mouth hemorrhage	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
General disorders Multi-organ failure	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Skin and subcutaneous tissue disorders Night sweats	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Parainfluenzae virus infection	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Periorbital cellulitis	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Pneumonia fungal	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Respiratory, thoracic and mediastinal disorders Sinus congestion	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Vascular disorders Thrombophlebitis superficial	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Upper respiratory tract infection	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Renal and urinary disorders Urinary hesitation	0.00% 0/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	5.6% 2/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Renal and urinary disorders Urinary incontinence	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Urinary tract infection	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Urinary tract infection bacterial	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.
Infections and infestations Vaginal infection	5.3% 2/38 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.	0.00% 0/36 • Adverse event data were collected from the first dose of treatment up to 30 days from the last dose of treatment in the safety analysis set. Two participants in the quizartinib 60 mg cohort did not receive the study drug and were not included in the safety analysis set.

Additional Information

Daiichi Sankyo

Contact for Clinical Trial Information

Phone: 1-908-992-6400

Email: CTRinfo@dsi.com

Results disclosure agreements

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