Phase 2 Study of Quizartinib in Participants With Acute M... | NCT02984995

ID	Type	Description	Link
JAPIC CTI-163441	Other Identifier	JAPIC CTI

Name	Class
Daiichi Sankyo	INDUSTRY

Label	Type	Description	Intervention Names
Initial dose 30 mg/day quizartinib	Experimental	Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.	Drug: Quizartinib
Initial dose 20 mg/day quizartinib	Experimental	Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.	Drug: Quizartinib

Name	Type	Description	Arm Group Labels	Other Names
Quizartinib	Drug	Quizartinib was orally administered once daily every morning. Treatment with quizartinib was administered in 28-day cycles and continued until the discontinuation criteria for treatment were met.

Measure	Description	Time Frame
Composite Complete Remission (CRc) Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML	The composite complete remission (CRc) rate is defined as the proportion of participants whose best response is complete remission [CR], CR with incomplete platelet recovery [CRp], or CR with incomplete hematological recovery [CRi]) after treatment with quizartinib.	Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 up until the end of treatment, except for responses from any subsequent AML therapy including transplantation

Measure	Description	Time Frame
Best Response After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML	Best response is defined as the best measured response over all response assessments (complete response [CR], CR with incomplete platelet recovery [CRp], CR with incomplete hematological recovery [CRi], partial remission [PR], no response [NR], or Unknown) at all time points after the first dose of the study drug to the end of treatment (does not include response from any subsequent AML therapy including transplantation).

Name	Affiliation	Role
Global Clinical Leader	Daiichi Sankyo	Study Director

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Initial Dose 30 mg/Day Quizartinib	Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
FG001	Initial Dose 20 mg/Day Quizartinib

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 19, 2017

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Composite Complete Remission (CRc) Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

The composite complete remission (CRc) rate is defined as the proportion of participants whose best response is complete remission [CR], CR with incomplete platelet recovery [CRp], or CR with incomplete hematological recovery [CRi]) after treatment with quizartinib.

All participants with FLT3-ITD positive relapsed or refractory AML who achieved CR, CRp, or CRi, discontinued the study treatment, or completed response assessment at Cycle 4 Day 1.

Posted

Number

90% Confidence Interval

percentage of participants

Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 up until the end of treatment, except for responses from any subsequent AML therapy including transplantation

ID	Title	Description
OG000	Initial Dose 30 mg/Day Quizartinib	Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
OG001	Initial Dose 20 mg/Day Quizartinib	Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
OG002	Total	All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.

Units	Counts
Participants	OG00023 OG0013 OG00226

Title

Denominators

Categories

Title	Measurements
	OG00056.5(37.5 to 74.2) OG00133.3(1.7 to 86.5) OG00253.8(36.2 to 70.8)

Secondary

Best Response After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

Best response is defined as the best measured response over all response assessments (complete response [CR], CR with incomplete platelet recovery [CRp], CR with incomplete hematological recovery [CRi], partial remission [PR], no response [NR], or Unknown) at all time points after the first dose of the study drug to the end of treatment (does not include response from any subsequent AML therapy including transplantation).

All participants with FLT3-ITD positive relapsed or refractory AML who achieved CR, CRp, CRi, or PR, discontinued the study treatment, or completed response assessment at Cycle 4 Day 1.

Posted

Count of Participants

Participants

Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML

ID	Title	Description
OG000	Initial Dose 30 mg/Day Quizartinib	Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
OG001	Initial Dose 20 mg/Day Quizartinib	Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
OG002

Secondary

Response Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

All participants with FLT3-ITD positive relapsed or refractory AML who achieved CR, CRp, CRi, or PR, discontinued the study treatment, or completed response assessment at Cycle 4 Day 1.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML

ID	Title	Description
OG000	Initial Dose 30 mg/Day Quizartinib	Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
OG001	Initial Dose 20 mg/Day Quizartinib	Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
OG002	Total	All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.

Secondary

Duration of Composite Complete Remission (CRc) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

Duration from the date of first composite complete remission (CRc) (complete remission [CR], CR with incomplete platelet recovery [CRp], or CR with incomplete hematological recovery [CRi]) observed to the date of documented relapse was assessed.

All participants with FLT3-ITD positive relapsed or refractory AML who had a documented best response of CRc.

Posted

Median

95% Confidence Interval

weeks

Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 up until the end of treatment, except for responses from any subsequent AML therapy including transplantation

ID	Title	Description
OG000	Initial Dose 30 mg/Day Quizartinib	Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
OG001	Initial Dose 20 mg/Day Quizartinib	Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
OG002	Total	All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.

Secondary

Overall Survival (OS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

OS is defined as the time from registration (enrollment) until death from any cause.

All participants with FLT3-ITD positive relapsed or refractory AML.

Posted

Median

95% Confidence Interval

weeks

Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 1 year

ID	Title	Description
OG000	Initial Dose 30 mg/Day Quizartinib	Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
OG001	Initial Dose 20 mg/Day Quizartinib	Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
OG002	Total	All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.

Secondary

Event-free Survival (EFS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

Event-free survival is defined as the time from date of registration until documented refractory disease, relapse after response of composite complete remission (CRc = complete remission [CR], CR with incomplete platelet recovery [CRp], or CR with incomplete hematological recovery [CRi]), or death from any cause, whichever occurs first.

All participants with FLT3-ITD positive relapsed or refractory AML.

Posted

Median

95% Confidence Interval

weeks

Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 32 weeks

ID	Title	Description
OG000	Initial Dose 30 mg/Day Quizartinib	Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
OG001	Initial Dose 20 mg/Day Quizartinib	Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
OG002	Total

Secondary

Leukemia-free Survival (LFS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

Leukemia-free survival (LFS) is the time from the first documented response of CRc until documented relapse or death from any cause. The analysis for LFS will be conditional on the participant having a documented best response of CRc.

All participants with FLT3-ITD positive relapsed or refractory AML and documented best response of CRc.

Posted

Median

95% Confidence Interval

weeks

Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 28 weeks

ID	Title	Description
OG000	Initial Dose 30 mg/Day Quizartinib	Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
OG001	Initial Dose 20 mg/Day Quizartinib	Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
OG002	Total	All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.

Secondary

Hematopoietic Stem Cell Transplantation Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

Proportion of participants who start hematopoietic stem cell transplantation (HSCT) immediately after the end of treatment with the study drug without receiving other treatment for AML, except for conditioning regiment for HSCT, was assessed.

All participants with FLT3-ITD positive relapsed or refractory AML who underwent HSCT after treatment.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to new AML treatment or 1 year post treatment

ID	Title	Description
OG000	Initial Dose 30 mg/Day Quizartinib	Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
OG001	Initial Dose 20 mg/Day Quizartinib	Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
OG002	Total	All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.

Secondary

Change in the Area Under the Plasma Concentration Time Curve (AUC) of Quizartinib and Its Active Metabolite After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

Pharmacokinetic (PK) parameters were assessed in the PK Analysis Set.

Posted

Mean

Standard Deviation

ng*h/mL

Cycle 1, Days 1 and 15; Cycle 2, Day 1

ID	Title	Description
OG000	Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)	Patients who received a CYP3A4 strong inhibitor received quizartinib 20 mg/day and escalated to 30 mg/day at Day 15.
OG001	Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)	Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 30 mg/day.
OG002	Quizartinib 30 mg/Day (With Use of Strong CYP3A4 Inhibitor)	Patients who received a CYP3A4 strong inhibitor received quizartinib 30 mg/day.
OG003	Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)	Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.

Secondary

Change in the Maximum Plasma Concentration (Cmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

Pharmacokinetic (PK) parameters were assessed in the PK Analysis Set.

Posted

Mean

Standard Deviation

ng/mL

Cycle 1, Days 1 and 15; Cycle 2, Day 1

ID	Title	Description
OG000	Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)	Patients who received a CYP3A4 strong inhibitor received quizartinib 20 mg/day and escalated to 30 mg/day at Day 15.
OG001	Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)	Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 30 mg/day.
OG002	Quizartinib 30 mg/Day (With Use of Strong CYP3A4 Inhibitor)	Patients who received a CYP3A4 strong inhibitor received quizartinib 30 mg/day.
OG003	Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)	Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.

Secondary

Change in the Trough Plasma Concentration (Ctrough) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

Pharmacokinetic (PK) parameters were assessed in the PK Analysis Set.

Posted

Mean

Standard Deviation

ng/mL

Cycle 1, Day 15

ID	Title	Description
OG000	Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)	Patients who received a CYP3A4 strong inhibitor received quizartinib 20 mg/day and escalated to 30 mg/day at Day 15.
OG001	Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)	Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 30 mg/day.
OG002	Quizartinib 30 mg/Day (With Use of Strong CYP3A4 Inhibitor)	Patients who received a CYP3A4 strong inhibitor received quizartinib 30 mg/day.
OG003	Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)	Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.

Secondary

Change in the Time to Reach Maximum Plasma Concentration (Tmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML

Pharmacokinetic (PK) parameters were assessed in the PK Analysis Set.

Posted

Median

Full Range

Cycle 1, Days 1 and 15; Cycle 2, Day 1

ID	Title	Description
OG000	Quizartinib 20 mg/Day (With Use of Strong CYP3A4 Inhibitor)	Patients who received a CYP3A4 strong inhibitor received quizartinib 20 mg/day and escalated to 30 mg/day at Day 15.
OG001	Quizartinib 30 mg/Day (With No Use of Strong CYP3A4 Inhibitor)	Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 30 mg/day.
OG002	Quizartinib 30 mg/Day (With Use of Strong CYP3A4 Inhibitor)	Patients who received a CYP3A4 strong inhibitor received quizartinib 30 mg/day.
OG003	Quizartinib 60 mg/Day (With No Use of Strong CYP3A4 Inhibitor)	Patients who did not receive a CYP3A4 strong inhibitor received quizartinib 60 mg/day.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bacteremia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected3 at risk EG0022 affected37 at risk
Sepsis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0011 affected3 at risk EG0022 affected37 at risk
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Encephalitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected34 at risk EG0012 affected3 at risk EG0026 affected37 at risk
Anemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected34 at risk EG0011 affected3 at risk EG0021 affected37 at risk
Hematoma	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Shock hemorrhagic	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Hemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Organizing pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Pyoderma gangrenosum	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Disease progression	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Edema peripheral	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk
Platelet count decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0010 affected3 at risk EG0021 affected37 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acarodermatitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 affected34 at risk EG0010 affected3 at risk EG0023 affected37 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 affected34 at risk EG0010 affected3 at risk EG0023 affected37 at risk
Bacteremia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected3 at risk EG0022 affected37 at risk
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected3 at risk EG0022 affected37 at risk
Device-related infections	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected3 at risk EG0022 affected37 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG00010 affected34 at risk EG0010 affected3 at risk EG00210 affected37 at risk
Anemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0008 affected34 at risk EG0011 affected3 at risk EG0029 affected37 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected34 at risk EG0011 affected3 at risk EG0024 affected37 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0011 affected3 at risk EG0022 affected37 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected34 at risk EG0011 affected3 at risk EG0025 affected37 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected34 at risk EG0010 affected3 at risk EG0024 affected37 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected34 at risk EG0010 affected3 at risk EG0024 affected37 at risk
Dysgeusia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected34 at risk EG0010 affected3 at risk EG0023 affected37 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected34 at risk EG0010 affected3 at risk EG0023 affected37 at risk
Hypotension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected34 at risk EG0011 affected3 at risk EG0022 affected37 at risk
Phlebitis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected3 at risk EG0022 affected37 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected3 at risk EG0022 affected37 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0009 affected34 at risk EG0012 affected3 at risk EG00211 affected37 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0006 affected34 at risk EG0010 affected3 at risk EG0026 affected37 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected34 at risk EG0010 affected3 at risk EG0024 affected37 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0011 affected3 at risk EG0023 affected37 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected34 at risk EG0010 affected3 at risk EG0023 affected37 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected3 at risk EG0022 affected37 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected3 at risk EG0022 affected37 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected34 at risk EG0011 affected3 at risk EG0024 affected37 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected34 at risk EG0010 affected3 at risk EG0023 affected37 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected3 at risk EG0022 affected37 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected3 at risk EG0022 affected37 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected34 at risk EG0011 affected3 at risk EG0024 affected37 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected34 at risk EG0010 affected3 at risk EG0023 affected37 at risk
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected34 at risk EG0011 affected3 at risk EG0025 affected37 at risk
Edema	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0011 affected3 at risk EG0023 affected37 at risk
Malaise	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected3 at risk EG0022 affected37 at risk
Edema peripheral	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected3 at risk EG0022 affected37 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 20.1	Systematic Assessment	EG00012 affected34 at risk EG0011 affected3 at risk EG00213 affected37 at risk
Platelet count decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG00013 affected34 at risk EG0010 affected3 at risk EG00213 affected37 at risk
Neutrophil count decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0008 affected34 at risk EG0010 affected3 at risk EG0028 affected37 at risk
White blood cell count decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0008 affected34 at risk EG0010 affected3 at risk EG0028 affected37 at risk
Alanine aminotransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0004 affected34 at risk EG0010 affected3 at risk EG0024 affected37 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0003 affected34 at risk EG0010 affected3 at risk EG0023 affected37 at risk
Liver function test increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0003 affected34 at risk EG0010 affected3 at risk EG0023 affected37 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected3 at risk EG0022 affected37 at risk
Blood uric acid increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0010 affected3 at risk EG0022 affected37 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 affected34 at risk EG0011 affected3 at risk EG0023 affected37 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected34 at risk EG0012 affected3 at risk EG0022 affected37 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Aichi			Japan

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Title	Description
BG000	Initial Dose 30 mg/Day Quizartinib	Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.
BG001	Initial Dose 20 mg/Day Quizartinib	Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Initial Dose 30 mg/Day Quizartinib	Participants who received an initial dose of 30 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 60 mg/day at Day 15.	13	34	14	34	34	34
EG001	Initial 20 mg/Day Quizartinib	Participants who received a CYP3A4 strong inhibitor received an initial dose of 20 mg/day of quizartinib and, if no QT prolongation, the dose escalated to 30 mg/day at Day 15.	1	3	3	3	3	3
EG002	Total	All participants who received either 30 mg/day or 20 mg/day quizartinib as an initial dose.	14	37	17	37	37	37