Efficacy Study for AC220 to Treat Acute Myeloid Leukemia... | NCT00989261

ID	Type	Description	Link
2009-013093-41	EudraCT Number

Label	Type	Description	Intervention Names
Cohort 1; ≥60 years of age	Experimental	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-) After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.	Drug: Compound AC220
Cohort 2; ≥18 years of age	Experimental	Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib. Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-) After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.	Drug: Compound AC220

Name	Type	Description	Arm Group Labels	Other Names
Compound AC220	Drug	Precomplexed powder in bottle formulation supplied as 200 mg in a 60 cc polyethylene terephthalate (PET) plastic bottle. Requires reconstitution by a pharmacist, must be stored securely, and protected from light.

Measure	Description	Time Frame
Derived Disease Assessment Based on Local Morphology Including All On-Treatment Data (Safety Population, FLT3-ITD [+] Participants)	Derived disease assessment based on local morphology of bone marrow disease performed by each local site pathologist, including all on-treatment data (Safety Population, FLT3-ITD[+] Participants) Modified from Cheson et al, abbreviations include the following: CR=complete remission; CRc=composite complete remission (CR+CRp+CRi); CRi=complete remission with incomplete hematological recovery, includes participants who met CRia criteria plus participants who met CRib criteria; CRia=all criteria specified for CR are met except for incomplete hematological recovery with residual neutropenia <1 x 10^9/L with or without complete platelet recovery. Red blood cell and platelet transfusion independence is not required; CRib=All criteria for CR or CRp are met, except for recent red blood cell or platelet transfusion; CRp=complete remission with incomplete platelet recovery; NR=no response; PR=partial remission.	Within the first 3 cycles of treatment (84 days)
Derived Disease Assessment Based on Local Morphology Including All On-Treatment Data (Safety Population, FLT3-ITD [-] Participants)	Derived disease assessment based on local morphology of bone marrow disease performed by each local site pathologist, including all on-treatment data (Safety Population, FLT3-ITD[-] Participants) Modified from Cheson et al, abbreviations include the following: CR=complete remission; CRc=composite complete remission (CR+CRp+CRi); CRi=complete remission with incomplete hematological recovery, includes participants who met CRia criteria plus participants who met CRib criteria; CRia=all criteria specified for CR are met except for incomplete hematological recovery with residual neutropenia <1 x 10^9/L with or without complete platelet recovery. Red blood cell and platelet transfusion independence is not required; CRib=All criteria for CR or CRp are met, except for recent red blood cell or platelet transfusion; CRp=complete remission with incomplete platelet recovery; NR=no response; PR=partial remission.	Within the first 3 cycles of treatment (84 days)
Number of Participants With Composite Complete Remission (CRc), Categorised by FLT3-ITD Status

Measure	Description	Time Frame
Duration of Composite Complete Remission in FLT3-ITD (+) Participants Who Achieved CRc Based on All On-Treatment Data	Kaplan-Meier analysis of duration of composite complete remission derived based on local morphology including all on-treatment data (Safety Population). The definition of relapse at CRc includes an evaluation of blasts in the peripheral blood of >1%.Though not specified in the protocol, the addition of these criteria was deemed necessary for consistency with the Cheson criteria.

Name	Affiliation	Role
Interim Chief Medical Officer	Ambit Biosciences Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco		San Francisco	California	94143	United States
Northwestern Memorial Hospital

PubMed Identifier	Type	Citation	Retractions
29859851	Derived	Cortes J, Perl AE, Dohner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Kramer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.

ID	Title	Description
FG000	Cohort 1; ≥60 Years of Age	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-) After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.

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

Derived Disease Assessment Based on Local Morphology Including All On-Treatment Data (Safety Population, FLT3-ITD [+] Participants)

Derived disease assessment based on local morphology of bone marrow disease performed by each local site pathologist, including all on-treatment data (Safety Population, FLT3-ITD[+] Participants)

Modified from Cheson et al, abbreviations include the following: CR=complete remission; CRc=composite complete remission (CR+CRp+CRi); CRi=complete remission with incomplete hematological recovery, includes participants who met CRia criteria plus participants who met CRib criteria; CRia=all criteria specified for CR are met except for incomplete hematological recovery with residual neutropenia <1 x 10^9/L with or without complete platelet recovery. Red blood cell and platelet transfusion independence is not required; CRib=All criteria for CR or CRp are met, except for recent red blood cell or platelet transfusion; CRp=complete remission with incomplete platelet recovery; NR=no response; PR=partial remission.

Derived disease assessments were conducted in the Safety Population (FLT3-ITD [+] participants).

Posted

Number

participants

Within the first 3 cycles of treatment (84 days)

ID	Title	Description
OG000	Cohort 1; ≥60 Years of Age	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1 Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.
OG001	Cohort 2; ≥18 Years of Age	Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib. Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0 Total (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.

Units	Counts
Participants	OG000112 OG001136

Title

Denominators

Categories

Composite complete remission (CRc)

Title	Measurements
	OG00063 OG00162

Complete remission (CR)

Title	Measurements
	OG000

Primary

Derived Disease Assessment Based on Local Morphology Including All On-Treatment Data (Safety Population, FLT3-ITD [-] Participants)

Derived disease assessment based on local morphology of bone marrow disease performed by each local site pathologist, including all on-treatment data (Safety Population, FLT3-ITD[-] Participants)

Derived disease assessments were conducted in the Safety Population (FLT3-ITD [-] participants).

Posted

Number

participants

Within the first 3 cycles of treatment (84 days)

ID	Title	Description
OG000	Cohort 1; ≥60 Years of Age	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1 Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.

Primary

Number of Participants With Composite Complete Remission (CRc), Categorised by FLT3-ITD Status

CRc is defined as composite complete remission (CR+CRp+CRi) - CR = complete remission; CRp = complete remission with incomplete platelet recovery; CRi = complete remission with incomplete hematological recovery, includes participants who met CRia criteria plus participants who met CRib criteria; CRia = all criteria specified for CR are met except for incomplete hematological recovery with residual neutropenia <1 x 10^9/L with or without complete platelet recovery. Red blood cell and platelet transfusion independence is not required; CRib = all criteria for CR or CRp are met, except for recent red blood cell or platelet transfusion.

Composite complete remission was assessed in the Safety Population.

Posted

Number

participants

within 28 months

ID	Title	Description
OG000	Cohort 1; ≥60 Years of Age	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1 Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.
OG001	Cohort 2; ≥18 Years of Age

Secondary

Duration of Composite Complete Remission in FLT3-ITD (+) Participants Who Achieved CRc Based on All On-Treatment Data

Kaplan-Meier analysis of duration of composite complete remission derived based on local morphology including all on-treatment data (Safety Population).

The definition of relapse at CRc includes an evaluation of blasts in the peripheral blood of >1%.Though not specified in the protocol, the addition of these criteria was deemed necessary for consistency with the Cheson criteria.

Duration of composite complete remission was assessed in the Safety Population based on FLT3-ITD (+) participants available for this analysis (Cohort 1: n=63; Cohort 2: n=62).

Posted

Median

95% Confidence Interval

weeks

From time at which CRc was achieved until disease progression or death, up to approximately 3 years post treatment

ID	Title	Description
OG000	Cohort 1; ≥60 Years of Age	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1 Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.
OG001	Cohort 2; ≥18 Years of Age

Secondary

Duration of Composite Complete Remission in FLT3-ITD (-) Participants Who Achieved CRc Based on All On-Treatment Data

Kaplan-Meier analysis of duration of composite complete remission derived based on local morphology including all on-treatment data (Safety Population).

Duration of composite complete remission was assessed in the Safety Population based on FLT3-ITD (-) participants available for this analysis (Cohort 1: n=16; Cohort 2: n=12).

Posted

Median

95% Confidence Interval

weeks

From time at which CRc was achieved until disease progression or death, up to approximately 3 years post treatment

ID	Title	Description
OG000	Cohort 1; ≥60 Years of Age	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1 Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.
OG001	Cohort 2; ≥18 Years of Age

Secondary

Duration of Any Response in FLT3-ITD (+) Participants

Kaplan-Meier analysis of duration of any response (CR, CRp, CRi, or PR), derived based on local morphology for participants who achieved a response during the first 3 cycles of treatment (Safety Population).

Response (based on local morphology) was assessed in the Safety Population (FLT3-ITD [+] participants).

Posted

Median

95% Confidence Interval

weeks

From the time of any response until disease progression or death, up to approximately 3 years post treatment

ID	Title	Description
OG000	Cohort 1; ≥60 Years of Age	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1 Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.
OG001	Cohort 2; ≥18 Years of Age	Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib. Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0 Total (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.

Secondary

Duration of Any Response in FLT3-ITD (-) Participants

Response (based on local morphology) was assessed in the Safety Population (FLT3-ITD [-] participants).

Posted

Median

95% Confidence Interval

weeks

From the time of any response until disease progression or death, up to approximately 3 years post treatment

ID	Title	Description
OG000	Cohort 1; ≥60 Years of Age	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1 Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.
OG001	Cohort 2; ≥18 Years of Age	Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib. Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0 Total (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.

Secondary

Median Duration of Leukemia-free Survival in FLT3-ITD (+) Participants

Kaplan-Meier analysis of leukemia-free survival in participants who achieved a CRc in the first three cycles of treatment derived based on local morphology (Safety Population).

Leukemia-free survival (based on local morphology) was assessed in the Safety Population (FLT3-ITD [+] participants).

Posted

Median

95% Confidence Interval

weeks

From the time CRc was achieved until disease progression or death, up to approximately 3 years post treatment

ID	Title	Description
OG000	Cohort 1; ≥60 Years of Age	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1 Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.
OG001	Cohort 2; ≥18 Years of Age	Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib. Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0 Total (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.

Secondary

Median Duration of Leukemia-free Survival in FLT3-ITD (-) Participants

Kaplan-Meier analysis of leukemia-free survival in participants who achieved a CRc in the first three cycles of treatment derived based on local morphology (Safety Population).

Leukemia-free survival (based on local morphology) was assessed in the Safety Population (FLT3-ITD [-] participants).

Posted

Median

95% Confidence Interval

weeks

From the time CRc was achieved until disease progression or death, up to approximately 3 years post treatment

ID	Title	Description
OG000	Cohort 1; ≥60 Years of Age	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1 Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.
OG001	Cohort 2; ≥18 Years of Age	Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib. Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0 Total (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.

Secondary

Median Duration of Overall Survival in FLT3-ITD (+) Participants

Kaplan-Meier analysis of overall survival (Safety Population)

Overall survival was assessed in the Safety Population (FLT3-ITD [+] participants).

Posted

Median

95% Confidence Interval

weeks

Time from first dose to death from any cause, up to 3 years post treatment

ID	Title	Description
OG000	Cohort 1; ≥60 Years of Age	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1 Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.
OG001	Cohort 2; ≥18 Years of Age	Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib. Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0 Total (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.

Secondary

Median Duration of Overall Survival in FLT3-ITD (-) Participants

Kaplan-Meier analysis of overall survival (Safety Population)

Overall survival was assessed in the Safety Population (FLT3-ITD [-] participants).

Posted

Median

95% Confidence Interval

weeks

Time from first dose to death from any cause, up to approximately 3 years post treatment

ID	Title	Description
OG000	Cohort 1; ≥60 Years of Age	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1 Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.
OG001	Cohort 2; ≥18 Years of Age	Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib. Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0 Total (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.

Secondary

Early Treatment-related Death

Early treatment-related deaths included all treatment-related deaths prior to the end of Cycle 3 with a 3-day window (Cycle 3 end date + 3 days), unless the death was following a CRc response assessed by the Investigator.

Early treatment-related deaths were assessed in the Safety Population.

Posted

Number

participants

Within first 3 cycles of treatment (84 days)

ID	Title	Description
OG000	Cohort 1; ≥60 Years of Age	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1 Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.
OG001	Cohort 2; ≥18 Years of Age	Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib. Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0 Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0 Total (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0 After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hematoma	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0013 affected176 at risk
Hemorrhage	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Hypotension	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0003 affected157 at risk EG0010 affected176 at risk
Acute myeloid leukemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG00037 affected157 at risk EG00136 affected176 at risk
Leukemic infiltration brain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Lymphohistiocytosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Graft versus host disease in skin	Immune system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Asthenia	General disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0011 affected176 at risk
Death	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Fatigue	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0012 affected176 at risk
General physical health deterioration	General disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0014 affected176 at risk
Localized edema	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Multi-organ failure	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Edema peripheral	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Pain	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Pyrexia	General disorders	MedDRA 15.0	Systematic Assessment	EG00010 affected157 at risk EG0018 affected176 at risk
Secretion discharge	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Anxiety	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Confusional state	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Delirium	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Mental status changes	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0003 affected157 at risk EG0011 affected176 at risk
Vaginal hemorrhage	Reproductive system and breast disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Accidental poisoning	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Endotracheal intubation complication	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Subdural hematoma	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0003 affected157 at risk EG0010 affected176 at risk
Subdural hemorrhage	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Alanine aminotransferase increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0013 affected176 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Blood bilirubin increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0014 affected176 at risk
Blood potassium decreased	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
C-reactive protein increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Ejection fraction decreased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 15.0	Systematic Assessment	EG00017 affected157 at risk EG00116 affected176 at risk
Hepatic enzyme increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Troponin T increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0008 affected157 at risk EG0013 affected176 at risk
Cardiac arrest	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0012 affected176 at risk
Cardiac failure	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0003 affected157 at risk EG0010 affected176 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Myocardial infarction	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0010 affected176 at risk
Myocardial ischemia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Tachycardia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Torsade de pointes	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Acute promyelocytic leukemia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0013 affected176 at risk
Hemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0010 affected176 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Pulmonary alveolar hemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0012 affected176 at risk
Anemia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0007 affected157 at risk EG0016 affected176 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0004 affected157 at risk EG0013 affected176 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG00060 affected157 at risk EG00166 affected176 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0010 affected176 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0012 affected176 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0013 affected176 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0004 affected157 at risk EG0016 affected176 at risk
Aphasia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Central nervous system lesion	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Cerebral hemorrhage	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0011 affected176 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0013 affected176 at risk
Cognitive disorder	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Coma	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Convulsion	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Dizziness	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Encephalitis	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Hemorrhage intracranial	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0004 affected157 at risk EG0011 affected176 at risk
Hemorrhagic stroke	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0011 affected176 at risk
Intraventricular hemorrhage	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Memory impairment	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Postictal state	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Somnolence	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Subarachnoid hemorrhage	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Syncope	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Transient ischemic attack	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0010 affected176 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0012 affected176 at risk
Barrett's esophagus	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Colitis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Dental caries	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0003 affected157 at risk EG0013 affected176 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Fecal incontinence	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Gastric hemorrhage	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Gastritis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0004 affected157 at risk EG0017 affected176 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Hemorrhoids	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Ileitis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Lower gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Melena	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Mouth hemorrhage	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0015 affected176 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Esophagitis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Rectal hemorrhage	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0012 affected176 at risk
Upper gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0004 affected157 at risk EG0011 affected176 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0014 affected176 at risk
Hematuria	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Renal failure	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0003 affected157 at risk EG0010 affected176 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0011 affected176 at risk
Renal tubular disorder	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Urinary retention	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Hyperbilirubinemia	Hepatobiliary disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0012 affected176 at risk
Acute febrile neutrophilic dermatosis	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0013 affected176 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Muscle hemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0010 affected176 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0012 affected176 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0005 affected157 at risk EG0012 affected176 at risk
Hypernatremia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Hypocalcemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Hypoglycemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Hyponatremia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Tumor lysis syndrome	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Abscess neck	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Acinetobacter bacteremia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Acute sinusitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Anal abscess	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Anorectal infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Arthritis bacterial	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Bacteremia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0006 affected157 at risk EG0014 affected176 at risk
Bacterial sepsis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0012 affected176 at risk
Breast cellulitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Bronchiolitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Bronchitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0011 affected176 at risk
Candidiasis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Cellulitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0005 affected157 at risk EG0013 affected176 at risk
Cellulitis orbital	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Clostridial infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0013 affected176 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0011 affected176 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Device related infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0014 affected176 at risk
Enterobacter bacteremia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Enterobacter infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Enterococcal infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Escherichia bacteremia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Escherichia infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Escherichia sepsis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Febrile infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Gingival infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Hepatic infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Herpes zoster	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0011 affected176 at risk
Influenza	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Klebsiella bacteremia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Klebsiella infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Laryngitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Lobar pneumonia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0011 affected176 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Lower respiratory tract infection fungal	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Lung infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0016 affected176 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Meningitis bacterial	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Mucosal infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Necrotizing fascitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Oral candidiasis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Oral herpes	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Oral infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Osteomyelitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Pericoronitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Periodontitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Pharyngitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Pneumonia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG00024 affected157 at risk EG00116 affected176 at risk
Pneumonia fungal	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0017 affected176 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Pseudomonal bacteremia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Pseudomonas infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Rectal abscess	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Respiratory tract infection fungal	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Rhinovirus infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Sepsis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG00012 affected157 at risk EG00113 affected176 at risk
Sepsis syndrome	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Septic shock	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0003 affected157 at risk EG0013 affected176 at risk
Serratia bacteremia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Sinusitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Sinusitis fungal	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Skin infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0011 affected176 at risk
Soft tissue infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Staphylococcal bacteremia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0012 affected176 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0013 affected176 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0006 affected157 at risk EG0016 affected176 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 affected157 at risk EG0010 affected176 at risk
Urosepsis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected157 at risk EG0011 affected176 at risk
Vulval abscess	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Vulval cellulitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Vulvitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk
Wound infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 affected157 at risk EG0010 affected176 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hematoma	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG00017 events17 affected157 at risk EG00112 events12 affected176 at risk
Hypotension	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG00017 events17 affected157 at risk EG00113 events13 affected176 at risk
Asthenia	General disorders	MedDRA 15.0	Systematic Assessment	EG00033 events33 affected157 at risk EG00132 events32 affected176 at risk
Chest pain	General disorders	MedDRA 15.0	Systematic Assessment	EG00010 events10 affected157 at risk EG00113 events13 affected176 at risk
Chills	General disorders	MedDRA 15.0	Systematic Assessment	EG00013 events13 affected157 at risk EG00114 events14 affected176 at risk
Fatigue	General disorders	MedDRA 15.0	Systematic Assessment	EG00062 events62 affected157 at risk EG00149 events49 affected176 at risk
Mucosal inflammation	General disorders	MedDRA 15.0	Systematic Assessment	EG0008 events8 affected157 at risk EG00115 events15 affected176 at risk
Edema peripheral	General disorders	MedDRA 15.0	Systematic Assessment	EG00046 events46 affected157 at risk EG00145 events45 affected176 at risk
Pyrexia	General disorders	MedDRA 15.0	Systematic Assessment	EG00047 events47 affected157 at risk EG00149 events49 affected176 at risk
Confusional state	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0008 events8 affected157 at risk EG0012 events2 affected176 at risk
Depression	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG00012 events12 affected157 at risk EG00110 events10 affected176 at risk
Insomnia	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG00011 events11 affected157 at risk EG00115 events15 affected176 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG00014 events14 affected157 at risk EG0016 events6 affected176 at risk
Alanine aminotransferse increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0009 events9 affected157 at risk EG00115 events15 affected176 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0008 events8 affected157 at risk EG0017 events7 affected176 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 15.0	Systematic Assessment	EG00031 events31 affected157 at risk EG00148 events48 affected176 at risk
Neutrophil count decreased	Investigations	MedDRA 15.0	Systematic Assessment	EG0008 events8 affected157 at risk EG0016 events6 affected176 at risk
Platelet count decreased	Investigations	MedDRA 15.0	Systematic Assessment	EG00017 events17 affected157 at risk EG00112 events12 affected176 at risk
Weight decreased	Investigations	MedDRA 15.0	Systematic Assessment	EG00010 events10 affected157 at risk EG00111 events11 affected176 at risk
Tachycardia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG00010 events10 affected157 at risk EG00110 events10 affected176 at risk
Anemia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG00044 events44 affected157 at risk EG00148 events48 affected176 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG00012 events12 affected157 at risk EG00114 events14 affected176 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG00010 events10 affected157 at risk EG00118 events18 affected176 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG00015 events15 affected157 at risk EG00120 events20 affected176 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0009 events9 affected157 at risk EG0012 events2 affected176 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG00022 events22 affected157 at risk EG00125 events25 affected176 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG00026 events26 affected157 at risk EG00137 events37 affected176 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG00028 events28 affected157 at risk EG00126 events26 affected176 at risk
Dyspnea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0008 events8 affected157 at risk EG0012 events2 affected176 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG00029 events29 affected157 at risk EG00127 events27 affected176 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0008 events8 affected157 at risk EG00110 events10 affected176 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0008 events8 affected157 at risk EG00112 events12 affected176 at risk
Dizziness	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG00027 events27 affected157 at risk EG00118 events18 affected176 at risk
Dysgeusia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG00044 events44 affected157 at risk EG00134 events34 affected176 at risk
Headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG00019 events19 affected157 at risk EG00124 events24 affected176 at risk
Paresthesia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG00013 events13 affected157 at risk EG0015 events5 affected176 at risk
Tremor	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG00010 events10 affected157 at risk EG0012 events2 affected176 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG00019 events19 affected157 at risk EG00123 events23 affected176 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG00024 events24 affected157 at risk EG0013 events3 affected176 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG00035 events35 affected157 at risk EG00136 events36 affected176 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG00065 events65 affected157 at risk EG00167 events67 affected176 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0008 events8 affected157 at risk EG0012 events2 affected176 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG00029 events29 affected157 at risk EG00125 events25 affected176 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG00016 events16 affected157 at risk EG0019 events9 affected176 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0006 events6 affected157 at risk EG0019 events9 affected176 at risk
Hemorrhoids	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG00010 events10 affected157 at risk EG0019 events9 affected176 at risk
Mouth hemorrhage	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG00012 events12 affected157 at risk EG00110 events10 affected176 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG00085 events85 affected157 at risk EG00189 events89 affected176 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0009 events9 affected157 at risk EG0017 events7 affected176 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG00057 events57 affected157 at risk EG00170 events70 affected176 at risk
Hematuria	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG00010 events10 affected157 at risk EG0019 events9 affected176 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0008 events8 affected157 at risk EG0019 events9 affected176 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG00011 events11 affected157 at risk EG00114 events14 affected176 at risk
Hair color changes	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0003 events3 affected157 at risk EG0019 events9 affected176 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG00032 events32 affected157 at risk EG00129 events29 affected176 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0008 events8 affected157 at risk EG0019 events9 affected176 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG00022 events22 affected157 at risk EG00124 events24 affected176 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0007 events7 affected157 at risk EG00112 events12 affected176 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG00014 events14 affected157 at risk EG0018 events8 affected176 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG00019 events19 affected157 at risk EG00117 events17 affected176 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG00011 events11 affected157 at risk EG0014 events4 affected176 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG00016 events16 affected157 at risk EG00110 events10 affected176 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG00012 events12 affected157 at risk EG00112 events12 affected176 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0007 events7 affected157 at risk EG00114 events14 affected176 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG00010 events10 affected157 at risk EG0014 events4 affected176 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG00017 events17 affected157 at risk EG00122 events22 affected176 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG00046 events46 affected157 at risk EG00143 events43 affected176 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG00013 events13 affected157 at risk EG00111 events11 affected176 at risk
Hypocalcemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG00015 events15 affected157 at risk EG00118 events18 affected176 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG00027 events27 affected157 at risk EG00133 events33 affected176 at risk
Hypomagnesemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG00017 events17 affected157 at risk EG00119 events19 affected176 at risk
Hyponatremia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0007 events7 affected157 at risk EG0019 events9 affected176 at risk
Oral candidiasis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0009 events9 affected157 at risk EG00110 events10 affected176 at risk
Oral herpes	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG00012 events12 affected157 at risk EG0019 events9 affected176 at risk
Pneumonia	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected157 at risk EG00115 events15 affected176 at risk
Sinusitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0003 events3 affected157 at risk EG0019 events9 affected176 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0009 events9 affected157 at risk EG0018 events8 affected176 at risk

ID	Term
D015470	Leukemia, Myeloid, Acute
D007938	Leukemia
D012008	Recurrence

ID	Term
D007951	Leukemia, Myeloid
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations

ID	Title	Description
BG000	Cohort 1; ≥60 Years of Age	Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-) After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.
BG001	Cohort 2; ≥18 Years of Age	Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib. Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-) After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.
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	Cohort 1; ≥60 Years of Age	FLT3-ITD positive and negative populations will be divided into 2 cohorts as follows: Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission <12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib. Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-) After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.	71	157	134	157	151	157
EG001	Cohort 2; ≥18 Years of Age	Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib. Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-) After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.	60	176	135	176	175	176