Dose Escalation Study Investigating the Safety, Tolerabil... | NCT02014558 | Trialant
NCT02014558
Sponsor
Astellas Pharma Global Development, Inc.
Status
Completed
Last Update Posted
Dec 3, 2024Actual
Enrollment
265Actual
Phase
Phase 1Phase 2
Conditions
Acute Myeloid Leukemia
Interventions
Gilteritinib
Voriconazole
Midazolam
Cephalexin
Countries
United States
Germany
Italy
Protocol Section
Identification Module
NCT ID
NCT02014558
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2215-CL-0101
Secondary IDs
Not provided
Brief Title
Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official Title
A Phase 1/2 Open-Label, Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Acronym
Not provided
Organization
Astellas Pharma IncINDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03070093Approved for marketing
Start Date
Oct 9, 2013Actual
Primary Completion Date
Aug 4, 2017Actual
Completion Date
Mar 7, 2018Actual
First Submitted Date
Nov 6, 2013
First Submission Date that Met QC Criteria
Dec 12, 2013
First Posted Date
Dec 18, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 19, 2018
Results First Submitted that Met QC Criteria
Jan 31, 2019
Results First Posted Date
Feb 20, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 16, 2016
Certification/Extension First Submitted that Passed QC Review
Nov 16, 2016
Certification/Extension First Posted Date
Nov 17, 2016Estimated
Last Update Submitted Date
Nov 7, 2024
Last Update Posted Date
Dec 3, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Astellas Pharma Global Development, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The objective of this study was to assess the safety and tolerability, including the maximum tolerated dose, of gilteritinib in participants with relapsed or treatment-refractory acute myeloid leukemia (AML). This study also determined the pharmacokinetic (PK) parameters of gilteritinib.
Detailed Description
Not provided
Conditions Module
Conditions
Acute Myeloid Leukemia
Keywords
Acute Myeloid Leukemia
Gilteritinib
ASP2215
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
265Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Gilteritinib 20 mg in Escalation Phase
Experimental
Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Drug: Gilteritinib
Drug: Voriconazole
Gilteritinib 40 mg in Escalation Phase
Experimental
Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Drug: Gilteritinib
Gilteritinib 80 mg in Escalation Phase
Experimental
Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Drug: Gilteritinib
Gilteritinib 120 mg in Escalation Phase
Experimental
Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Gilteritinib
Drug
Participants received gilteritinib oral tablets (10 mg, 40 mg or 100 mg, depending on the dose) once daily without food allowed for at least 2 hours before and 1 hour after dosing starting from day -2 and day of cycle 1, for continuous 28-day cycles.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)
To determine the maximum tolerated dose, safety was assessed by DLTs, defined as any grade ≥ 3 non-hematologic or extramedullary toxicity that occurred within 30 days starting with the first dose taken on day -2, and included the first treatment cycle in the dose escalation phase and in the first treatment cycle (28 days) in the dose expansion phase, that was considered to be possibly or probably related to study drug. Exceptions to this were the following: (1) Alopecia, anorexia or fatigue, (2) Grade 3 nausea and/or vomiting if not required tube feeding or total parenteral nutrition, or diarrhea if not required or prolonged hospitalization that was managed to grade ≤ 2 with standard antiemetic or antidiarrheal medications used at prescribed dose within 7 days of onset, (3) Grade 3 fever with neutropenia, with or without infection, (4) Grade 3 infection.
From first dose up to end of cycle 1 (30 days)
Number of Participants With Adverse Events (AEs)
Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug up to 30 days after last dose of study drug (for participants who underwent hematopoietic stem cell transplantation [HSCT]: defined as AEs observed after starting study drug until the last dose before on study HSCT plus 30 days, and AEs that began after resumption of gilteritinib and within 30 days after the last dose of gilteritinib). AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (1-Mild, 2-Moderate, 3-Severe, 4-LifeThreatening, 5-Death).
From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Area Under the Concentration-time Curve Over the 24-Hour Dosing Interval (AUC24) After Single and Multiple Doses of Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Complete Remission (CR) During the First 2 Cycles
CR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CR when they had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an absolute neutrophil count (ANC) > 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, normal marrow differential with < 5% blasts, had been red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion), had no presence of Auer rods and no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Exact 95% confidence interval was estimated using binomial distribution.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subject is defined as morphologically documented primary or secondary AML by the World Health Organization (WHO) criteria (2008) and fulfills one of the following:
Refractory to at least 1 cycle of induction chemotherapy
Relapsed after achieving remission with a prior therapy
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Subject's interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), or at least 5 half-lives for prior experimental agents or noncytotoxic agents.
Subject must meet the following criteria as indicated on the clinical laboratory tests*:
Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x institutional upper limit normal (ULN)
Total serum bilirubin < 1.5x institutional ULN
Serum creatinine < 1.5 x institutional ULN or an estimated glomerular filtration rate (eGFR) of > 50 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation.
Subject agrees not to participate in another interventional study while on treatment.
Exclusion Criteria:
Subject was diagnosed as acute promyelocytic leukemia (APL).
Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
Subject has active malignant tumors other than AML or Myelodysplastic syndrome (MDS).
Subject has persistent nonhematological toxicities of >= Grade 2 (Common Terminology Criteria for Adverse Events v4), with symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery).
Subject has had hematopoietic stem cell transplant (HSCT) and meets any of the following:
Is within 2 months of transplant from C1D1
Has clinically significant graft-versus-host disease requiring treatment
Has >= Grade 2 persistent non-hematological toxicity related to the transplant. Donor lymphocytes infusion (DLI) is not permitted <= 30 days prior to study registration or during the first cycle of treatment on the study in Cohort 1 and first two cycles of the treatment in Cohort 2
Subject has clinically active central nervous system leukemia
Subject has disseminated intravascular coagulation abnormality (DIC)
Subject has had major surgery within 4 weeks prior to the first study dose.
Subject has had radiation therapy within 4 weeks prior to the first study dose
Subject has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ≥ 45%
Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of Cytochrome P450-isozyme3A4 (CYP3A4) with the exception of antibiotics, antifungals, and antivirals that are used as standard of care post-transplant or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject
Subject required treatment with concomitant drugs that target serotonin 5HT1R or 5HT2BR receptors or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.
Subject has an active uncontrolled infection
Subject is known to have human immunodeficiency virus infection
Subject has active hepatitis B or C, or other active hepatic disorder
James AJ, Smith CC, Litzow M, Perl AE, Altman JK, Shepard D, Kadokura T, Souda K, Patton M, Lu Z, Liu C, Moy S, Levis MJ, Bahceci E. Pharmacokinetic Profile of Gilteritinib: A Novel FLT-3 Tyrosine Kinase Inhibitor. Clin Pharmacokinet. 2020 Oct;59(10):1273-1290. doi: 10.1007/s40262-020-00888-w.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Participants with acute myeloid leukemia (AML) who relapsed after or were refractory to induction or salvage treatment were selected for this study. Five participants were re-enrolled into the dose-expansion cohorts as they discontinued treatment for reasons other than toxicity or disease progression, as long as they met the eligibility criteria.
Recruitment Details
This dose-escalation/dose-expansion study was conducted in sites in the United States, France, Germany and Italy. The study had 7 dose-escalation cohorts with ≥3 participants enrolled at each dose level. Following escalation to the next dose cohort, additional participants were enrolled to the dose-expansion cohorts per protocol-specified criteria.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Gilteritinib 20 mg in Escalation Phase
Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Re-enrolled participants (assigned to the 120 mg [1] & 200 mg [4] expansion groups) were excluded.
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 2, 2017
Dec 18, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
France
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Gilteritinib
Gilteritinib 200 mg in Escalation Phase
Experimental
Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Drug: Gilteritinib
Gilteritinib 300 mg in Escalation Phase
Experimental
Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Drug: Gilteritinib
Gilteritinib 450 mg in Escalation Phase
Experimental
Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Drug: Gilteritinib
Gilteritinib 20 mg in Expansion Phase
Experimental
Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
Drug: Gilteritinib
Gilteritinib 40 mg in Expansion Phase
Experimental
Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
Drug: Gilteritinib
Gilteritinib 80 mg in Expansion Phase
Experimental
Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
Drug: Gilteritinib
Gilteritinib 120 mg in Expansion Phase
Experimental
Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
Drug: Gilteritinib
Gilteritinib 200 mg in Expansion Phase
Experimental
Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
Drug: Gilteritinib
Drug: Cephalexin
Gilteritinib 300 mg in Expansion Phase
Experimental
Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Drug: Gilteritinib
Drug: Midazolam
Gilteritinib 120 mg in Escalation Phase
Gilteritinib 120 mg in Expansion Phase
Gilteritinib 20 mg in Escalation Phase
Gilteritinib 20 mg in Expansion Phase
Gilteritinib 200 mg in Escalation Phase
Gilteritinib 200 mg in Expansion Phase
Gilteritinib 300 mg in Escalation Phase
Gilteritinib 300 mg in Expansion Phase
Gilteritinib 40 mg in Escalation Phase
Gilteritinib 40 mg in Expansion Phase
Gilteritinib 450 mg in Escalation Phase
Gilteritinib 80 mg in Escalation Phase
Gilteritinib 80 mg in Expansion Phase
ASP2215
Voriconazole
Drug
Participants received 200 mg voriconazole tablets daily every 12 hours starting from day 16 of cycle 1 through day 1 of cycle 2.
Gilteritinib 20 mg in Escalation Phase
Midazolam
Drug
Participants received a single oral dose of 2 mg of midazolam syrup on day -1 and day 15 of cycle 1.
Gilteritinib 300 mg in Expansion Phase
Cephalexin
Drug
Participants received a single oral dose of 500 mg cephalexin tablet or capsule on day -1 and day 15 of cycle 1.
Gilteritinib 200 mg in Expansion Phase
Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose
Maximum Concentration (Cmax) After Single and Multiple Doses of Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose
Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) After Single and Multiple Doses of Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose
Time to Observed Cmax (Tmax) After Single and Multiple Doses of Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose
Terminal Elimination Half-life (t1/2) After Multiple Doses of Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Percentage of Participants With CR During Treatment
CR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CR when they had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an absolute neutrophil count (ANC) > 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, normal marrow differential with < 5% blasts, had been red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion), had no presence of Auer rods and no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Exact 95% confidence interval was estimated using binomial distribution.
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Percentage of Participants With CR With Incomplete Platelet Recovery (CRp)
CRp was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRp when they achieved CR except for incomplete platelet recovery (< 100 x 10^9/L). Exact 95% confidence interval was estimated using the binomial distribution.
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Percentage of Participants With CR With Incomplete Hematological Recovery (CRi)
CRi was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRi when they fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence were not required. Exact 95% confidence interval was estimated using the binomial distribution.
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh)
CRh was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRh when they could not be classified as being in CR and had bone marrow blasts < 5% and partial hematologic recovery ANC >= 0.5 x 10^9/L and platelets >= 50 x 10^9/L. There should not be evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution. CRh was calculated only for participants who were FLT3 mutation positive.
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Percentage of Participants With Composite CR (CRc)
CRc was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRc when they had achieved either CR, complete remission with incomplete platelet recovery (CRp, defined as had achieved CR except for incomplete platelet recovery (< 100 x 10^9/L) or complete remission with incomplete hematologic recovery (CRi, defined as had fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery; RBC platelet transfusion independence not required). Exact 95% confidence interval was estimated using the binomial distribution.
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Percentage of Participants With Partial Remission (PR)
PR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in PR when they had bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and with a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate with the total marrow blasts between 5% and 25%. A value of less or equal than 5% blasts was also considered a PR if Auer rods were present. There should be no evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution.
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Percentage of Participants With Best Response
Best response was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). BR was defined as the best measured response for all visits (in the order of CR, CRp, CRi, and PR) post-treatment. Participants who achieved the best response of CR, CRp, CRi or PR were classified as responders. Participants who did not achieve at least PR were considered as non-responders. Exact 95% confidence interval was estimated using the binomial distribution.
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Percentage of Participants With Complete Remission and Complete Remission With Partial Hematologic Recovery (CR/CRh)
Participants with CR/CRh were defined as participants who achieved either CR or CRh. Participants with CR had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an ANC > 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, and normal marrow differential with < 5% blasts, had been RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). Also, there had been no presence of Auer rods, no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Participants with CRh could not be classified as being in CR and had bone marrow blasts < 5%, partial hematologic recovery ANC >= 0.5 x 10^9/L and platelets >= 50 x 10^9/L. There should not be evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution. CR/CRh was calculated only for participants who were FLT3 mutation positive.
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Duration of CR (DCR)
DCR was defined as the time from the date of first CR until the date of documented relapse for participants who achieved CR. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study were considered non-events and censored at the last relapse-free disease assessment date. DCR was calculated using Kaplan-Meier method and therefore data are estimated.
From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Duration of CRp (DCRp)
DCRp was defined as the time from the date of first CRp until the date of documented relapse for participants who achieved CRp. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study were considered non-events and censored at the last relapse-free disease assessment date. DCRp was calculated using Kaplan-Meier method and therefore data are estimated.
From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Duration of CRi (DCRi)
DCRi was defined as the time from the date of first CRi until the date of documented relapse for participants who achieved CRi. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRi was calculated using Kaplan-Meier method and therefore data are estimated.
From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Duration of CRh (DCRh)
DCRh was defined as the time from the date of first CRh until the date of documented relapse for participants who achieved CRh but did not have a best response of CR. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRh was calculated using Kaplan-Meier method and therefore data are estimated. DCRh was calculated only for participants who were FLT3 mutation positive.
From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Duration of CRc (DCRc)
DCRc was defined as the time from the date of first CRc until the date of documented relapse for participants who achieved CRc. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRc was calculated using Kaplan-Meier method and therefore data are estimated.
From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Duration of CR/CRh (DCRCRh)
DCRCRh was defined as the time from the date of first DCRCRh until the date of documented relapse for participants who achieved CR or CRh. For participants who achieved both CR and CRh, the first CR date or CRh date, whichever occurred first, was used. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRCRh was calculated using Kaplan-Meier method and therefore data are estimated. DCRCRh was calculated only for participants who were FLT3 mutation positive.
From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Duration of Response
Duration of response was defined as the time from the date of either first CRc or PR until the date of documented relapse of any type for participants who achieved CRc or PR. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study are considered non-events and censored at the last relapse-free assessment date. Duration of response was calculated using Kaplan-Meier method and therefore data are estimated.
From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Time to CR (TTCR)
TTCR was defined as the time from the first dose of study drug until the date of first CR.
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Time to CRp (TTCRp)
TTCRp was defined as the time from the first dose of study drug until the date of first CRp. TTCRp was evaluated for participants who achieved CRp.
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Time to CRi (TTCRi)
TTCRi was defined as the time from the first dose of study drug until the date of first CRi. TTCRi was evaluated for participants who achieved CRi.
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Time to First CR/CRh (TTFCRCRh)
TTFCRCRh was defined as the time from the first dose of study drug until the date of first either CR or CRh. TTFCRCRh was evaluated for participants who achieved CR or CRh. For participants who achieve both CR and CRh, the first CR date or CRh date, whichever occurs first was used. TTFCRCRh was calculated only for participants who were FLT3 mutation positive.
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Time to Best CR/CRh (TTBCRCRh)
TTBCRCRh was defined as the time from the first dose of study drug until the first date that the best response of CR or CRh was achieved. TTBCRCRh was evaluated for participants who achieved CR or CRh. For participants who achieve both CR and CRh, the first CR date was used. TTBCRCRh was calculated only for participants who were FLT3 mutation positive.
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Time to CRc (TTCRc)
TTCRc was defined as the time from the first dose of study drug until the date of first CRc. TTCRc was evaluated for participants who achieved CRc.
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Time to Response (TTR)
TTR was defined as the time from the first dose of study drug until the date of either first CRc or PR. TTR was evaluated for participants who achieved CRc or PR.
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Time to Best Response (TTBR)
TTBR was defined as the time from the first dose of study drug until the first disease assessment date when participant achieved best response. TTBR was evaluated in participants who achieved best response of CR, CRp, CRi, or PR.
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Overall Survival (OS)
The time from the date of first dose of study drug until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact. OS was calculated using Kaplan-Meier method and therefore data are estimated.
From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)
Event Free Survival (EFS)
EFS was defined as the time from the date of first dose of study drug until the date of documented relapse, treatment failure or death from any cause, whichever occurred first. For a participant with none of these events, EFS was censored at the date of last relapse-free disease assessment. A participant without post-treatment disease assessment was censored at randomization date. Treatment failure included those participants who discontinued the treatment due to "progressive disease" or "lack of efficacy" without a previous response of CR, CRp, CRi or PR. Treatment failure date referred to the start of new anti-leukemia therapy or the last treatment evaluation date when new anti-leukemia therapy date was not available. For participants who were censored, last relapse-free disease assessment date referred to the participant's last disease assessment date. EFS was calculated using Kaplan-Meier method and therefore data are estimated.
From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)
Leukemia Free Survival (LFS)
LFS was defined as the time from the date of first CRc until the date of documented relapse or death for participants who achieved CRc. For a participant who was not known to have relapsed or died, LFS was censored on the date of last relapse-free disease assessment date. LFS was calculated using Kaplan-Meier method and therefore data are estimated.
From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)
Percentage of Participants Who Achieved Transfusion Conversion
Participants who achieved transfusion conversion were defined as the number of participants who were transfusion dependent at baseline period but became transfusion independent at post-baseline period divided by the total number of participants who were transfusion dependent at baseline period. Participants were considered baseline transfusion dependent if there were RBC or platelet transfusions within the baseline period. Participants were considered post-baseline transfusion independent if they were on treatment >=84 days, and if there was one consecutive 56 days without any RBC or platelet transfusion within post-baseline period. If participants were on treatment >28 days but <84 days, and there was no RBC or platelet transfusion within post-baseline period, or on treatment <=28 days, post-baseline transfusion status was not evaluable. Exact 95% confidence interval was estimated using the binomial distribution.
Baseline (28 days prior to first dose until 28 days after the first dose) and postbaseline (from 29 days after first dose date until last dose date); median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days
Percentage of Participants Who Achieved Transfusion Maintenance
Participants who achieved transfusion maintenance were defined as the number of participants who were transfusion independent at baseline period and still maintained transfusion independent at post-baseline period divided by the total number of participants who were transfusion independent at baseline period.
Baseline (28 days prior to first dose until 28 days after the first dose) and postbaseline (from 29 days after first dose date until last dose date); median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days
AUC24 of Gilteritinib in Co-administration With Voriconazole
Plasma samples were used for pharmacokinetic assessments.
Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)
Cmax of Gilteritinib in Co-administration With Voriconazole
Plasma samples were used for pharmacokinetic assessments.
Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)
AUClast of Gilteritinib in Co-administration With Voriconazole
Plasma samples were used for pharmacokinetic assessments.
Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)
Tmax of Gilteritinib in Co-administration With Voriconazole
Plasma samples were used for pharmacokinetic assessments.
Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)
AUC24 of Midazolam Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
AUC24 of Metabolite 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
Cmax of Midazolam Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
Cmax of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
AUClast of Midazolam Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
AUClast of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
Tmax of Midazolam Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
Tmax of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
Area Under the Concentration-time Curve From the Time of Dosing Extrapolated to Time Infinity (AUCinf) of Cephalexin Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)
Cmax of Cephalexin Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)
AUClast of Cephalexin Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)
Tmax of Cephalexin Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)
T1/2 of Cephalexin Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)
Apparent Total Systemic Clearance After Single or Multiple Extravascular Dosing (CL/F) of Cephalexin Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)
Apparent Volume of Distribution During the Terminal Elimination Phase After Single Extravascular Dosing (Vz/F) of Cephalexin Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)
Amount of Drug Excreted in Urine (Aelast) of Cephalexin Administered With and Without Gilteritinib
Urine samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)
Fraction of Drug Excreted Into Urine in Percentage (%Ae) of Cephalexin Administered With and Without Gilteritinib
Urine samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)
Renal Clearance (CLr) of Cephalexin in Administered With and Without Gilteritinib
Urine samples were used for pharmacokinetic assessments.
Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)
Scottsdale
Arizona
85259
United States
Site US10022
Duarte
California
91010
United States
Site US10008
Los Angeles
California
90095-1678
United States
Site US10005
San Francisco
California
94143
United States
Site US10001
Chicago
Illinois
60611
United States
Site US10015
Chicago
Illinois
60637
United States
Site US10012
Baltimore
Maryland
21201
United States
Site US10003
Baltimore
Maryland
21287
United States
Site US10006
Minneapolis
Minnesota
55455
United States
Site US10011
Rochester
Minnesota
55905
United States
Site US10020
Hackensack
New Jersey
07601
United States
Site US10010
Buffalo
New York
14263
United States
Site US10009
New York
New York
10022
United States
Site US10013
New York
New York
10032
United States
Site US10019
New York
New York
10065
United States
Site US10014
Cleveland
Ohio
44195
United States
Site US10018
Hershey
Pennsylvania
17033
United States
Site US10004
Philadelphia
Pennsylvania
19104
United States
Site US10017
Charleston
South Carolina
29425-8900
United States
Site US10007
Nashville
Tennessee
37232
United States
Site US10002
Houston
Texas
77030
United States
Site US10026
Fairfax
Virginia
22031
United States
Site DE49002
Berlin
12203
Germany
Site DE49004
Dresden
01307
Germany
Site IT39001
Bologna
40138
Italy
Perl AE, Altman JK, Cortes J, Smith C, Litzow M, Baer MR, Claxton D, Erba HP, Gill S, Goldberg S, Jurcic JG, Larson RA, Liu C, Ritchie E, Schiller G, Spira AI, Strickland SA, Tibes R, Ustun C, Wang ES, Stuart R, Rollig C, Neubauer A, Martinelli G, Bahceci E, Levis M. Selective inhibition of FLT3 by gilteritinib in relapsed or refractory acute myeloid leukaemia: a multicentre, first-in-human, open-label, phase 1-2 study. Lancet Oncol. 2017 Aug;18(8):1061-1075. doi: 10.1016/S1470-2045(17)30416-3. Epub 2017 Jun 20.
Kasi PM, Litzow MR, Patnaik MM, Hashmi SK, Gangat N. Clonal evolution of AML on novel FMS-like tyrosine kinase-3 (FLT3) inhibitor therapy with evolving actionable targets. Leuk Res Rep. 2016 Jan 12;5:7-10. doi: 10.1016/j.lrr.2016.01.002. eCollection 2016.
FG001
Gilteritinib 40 mg in Escalation Phase
Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
FG002
Gilteritinib 80 mg in Escalation Phase
Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
FG003
Gilteritinib 120 mg in Escalation Phase
Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
FG004
Gilteritinib 200 mg in Escalation Phase
Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
FG005
Gilteritinib 300 mg in Escalation Phase
Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
FG006
Gilteritinib 450 mg in Escalation Phase
Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
FG007
Gilteritinib 20 mg in Expansion Phase
Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
FG008
Gilteritinib 40 mg in Expansion Phase
Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
FG009
Gilteritinib 80 mg in Expansion Phase
Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
FG010
Gilteritinib 120 mg in Expansion Phase
Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
FG011
Gilteritinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
FG012
Gilteritinib 300 mg in Expansion Phase
Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
FG0005 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0044 subjects
FG0053 subjects
FG0064 subjects
FG00711 subjects
FG00815 subjects
FG00921 subjects
FG01069 subjects
FG011102 subjects
FG01217 subjects
Treated
FG0005 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0063 subjects
FG00712 subjectsA participant randomized to the 120 mg was treated with an initial dose of 20 mg by mistake.
FG00813 subjects
FG00921 subjects
FG01066 subjectsA participant randomized to the 120 mg was treated with an initial dose of 20 mg by mistake.
FG011100 subjects
FG01217 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG0005 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0044 subjects
FG0053 subjects
FG0064 subjects
FG00711 subjects
FG00815 subjects
FG00921 subjects
FG01069 subjects
FG011102 subjects
FG01217 subjects
Type
Comment
Reasons
Never Received Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0082 subjects
FG0090 subjects
FG0102 subjects
FG0112 subjects
FG0120 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive Disease
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Miscellaneous
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
The analysis population was the safety analysis set (SAF), which consisted of all participants who received at least 1 dose of study drug and excluded re-enrolled participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Gilteritinib 20 mg in Escalation Phase
Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
BG001
Gilteritinib 40 mg in Escalation Phase
Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
BG002
Gilteritinib 80 mg in Escalation Phase
Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
BG003
Gilteritinib 120 mg in Escalation Phase
Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
BG004
Gilteritinib 200 mg in Escalation Phase
Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
BG005
Gilteritinib 300 mg in Escalation Phase
Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
BG006
Gilteritinib 450 mg in Escalation Phase
Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
BG007
Gilteritinib 20 mg in Expansion Phase
Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
BG008
Gilteritinib 40 mg in Expansion Phase
Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
BG009
Gilteritinib 80 mg in Expansion Phase
Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
BG010
Gilteritinib 120 mg in Expansion Phase
Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
BG011
Gilteritinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
BG012
Gilteritinib 300 mg in Expansion Phase
Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005
BG0013
BG0023
BG0033
BG0043
BG0053
BG0063
BG00712
BG00813
BG00921
BG01066
BG011100
BG01217
BG013252
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG0005
ParticipantsBG0013
ParticipantsBG0023
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0005
ParticipantsBG0013
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0005
ParticipantsBG0013
ParticipantsBG002
Ethnicity
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0005
ParticipantsBG0013
ParticipantsBG002
Duration of Disease (AML)
The analysis population was the SAF, with participants with data available.
Mean
Standard Deviation
months
Title
Denominators
Categories
ParticipantsBG0004
ParticipantsBG0013
ParticipantsBG002
Local FLT3 Mutation Status
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0005
ParticipantsBG0013
ParticipantsBG002
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
Number of Participants With Dose Limiting Toxicities (DLTs)
To determine the maximum tolerated dose, safety was assessed by DLTs, defined as any grade ≥ 3 non-hematologic or extramedullary toxicity that occurred within 30 days starting with the first dose taken on day -2, and included the first treatment cycle in the dose escalation phase and in the first treatment cycle (28 days) in the dose expansion phase, that was considered to be possibly or probably related to study drug. Exceptions to this were the following: (1) Alopecia, anorexia or fatigue, (2) Grade 3 nausea and/or vomiting if not required tube feeding or total parenteral nutrition, or diarrhea if not required or prolonged hospitalization that was managed to grade ≤ 2 with standard antiemetic or antidiarrheal medications used at prescribed dose within 7 days of onset, (3) Grade 3 fever with neutropenia, with or without infection, (4) Grade 3 infection.
The analysis population was the SAF. Only evaluable participants (defined as participants who received at least 80% of the intended dose during cycle 1 [received at least 23 daily doses in escalation phase or 22 daily doses in expansion phase during cycle 1] or participants who developed DLT within cycle 1) were included.
Posted
Count of Participants
Participants
From first dose up to end of cycle 1 (30 days)
ID
Title
Description
OG000
Gilteritinib 20 mg in Escalation Phase
Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG001
Gilteritinib 40 mg in Escalation Phase
Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG002
Gilteritinib 80 mg in Escalation Phase
Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG003
Gilteritinib 120 mg in Escalation Phase
Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg in Escalation Phase
Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Any DLT
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Adverse Events (AEs)
Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug up to 30 days after last dose of study drug (for participants who underwent hematopoietic stem cell transplantation [HSCT]: defined as AEs observed after starting study drug until the last dose before on study HSCT plus 30 days, and AEs that began after resumption of gilteritinib and within 30 days after the last dose of gilteritinib). AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (1-Mild, 2-Moderate, 3-Severe, 4-LifeThreatening, 5-Death).
The analysis population was the SAF.
Posted
Count of Participants
Participants
From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg in Escalation Phase
Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Primary
Area Under the Concentration-time Curve Over the 24-Hour Dosing Interval (AUC24) After Single and Multiple Doses of Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
Pharmacokinetics analysis set (PKAS) - consisted of the subset of the SAF for which sufficient plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of dosing on the day of sampling was known. Participants with available data were included in the analysis.
Posted
Mean
Standard Deviation
ng*h/mL
Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose
ID
Title
Description
OG000
Gilteritinib 20 mg in Escalation Phase
Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG001
Gilteritinib 40 mg in Escalation Phase
Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Primary
Maximum Concentration (Cmax) After Single and Multiple Doses of Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS with available data.
Posted
Mean
Standard Deviation
ng/mL
Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose
ID
Title
Description
OG000
Gilteritinib 20 mg in Escalation Phase
Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study..
OG001
Gilteritinib 40 mg in Escalation Phase
Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study..
OG002
Gilteritinib 80 mg in Escalation Phase
Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Primary
Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) After Single and Multiple Doses of Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS with available data.
Posted
Mean
Standard Deviation
ng*h/mL
Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose
ID
Title
Description
OG000
Gilteritinib 20 mg in Escalation Phase
Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG001
Gilteritinib 40 mg in Escalation Phase
Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG002
Gilteritinib 80 mg in Escalation Phase
Primary
Time to Observed Cmax (Tmax) After Single and Multiple Doses of Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS with available data.
Posted
Median
Full Range
hours
Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose
ID
Title
Description
OG000
Gilteritinib 20 mg in Escalation Phase
Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG001
Gilteritinib 40 mg in Escalation Phase
Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG002
Gilteritinib 80 mg in Escalation Phase
Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Primary
Terminal Elimination Half-life (t1/2) After Multiple Doses of Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS with available data.
Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG001
Gilteritinib 40 mg in Escalation Phase
Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG002
Gilteritinib 80 mg in Escalation Phase
Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Primary
Accumulation Ratio After Multiple Doses of Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS with available data.
Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG001
Gilteritinib 40 mg in Escalation Phase
Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG002
Gilteritinib 80 mg in Escalation Phase
Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Secondary
Percentage of Participants With Complete Remission (CR) During the First 2 Cycles
CR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CR when they had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an absolute neutrophil count (ANC) > 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, normal marrow differential with < 5% blasts, had been red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion), had no presence of Auer rods and no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Exact 95% confidence interval was estimated using binomial distribution.
Full analysis set (FAS) - consisted of all participants who were enrolled, took at least 1 dose of study drug and who had at least 1 posttreatment data point. Re-enrolled participants and participants from one site due to concerns with this site's GCP compliance were excluded. Participants were summarized under planned reporting groups in the FAS.
Posted
Number
95% Confidence Interval
percentage of participants
During the first 2 cycles (56 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Percentage of Participants With CR During Treatment
CR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CR when they had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an absolute neutrophil count (ANC) > 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, normal marrow differential with < 5% blasts, had been red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion), had no presence of Auer rods and no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Exact 95% confidence interval was estimated using binomial distribution.
The analysis population was the FAS.
Posted
Number
95% Confidence Interval
percentage of participants
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Secondary
Percentage of Participants With CR With Incomplete Platelet Recovery (CRp)
CRp was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRp when they achieved CR except for incomplete platelet recovery (< 100 x 10^9/L). Exact 95% confidence interval was estimated using the binomial distribution.
The analysis population was the FAS.
Posted
Number
95% Confidence Interval
percentage of participants
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Percentage of Participants With CR With Incomplete Hematological Recovery (CRi)
CRi was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRi when they fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence were not required. Exact 95% confidence interval was estimated using the binomial distribution.
The analysis population was the FAS.
Posted
Number
95% Confidence Interval
percentage of participants
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh)
CRh was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRh when they could not be classified as being in CR and had bone marrow blasts < 5% and partial hematologic recovery ANC >= 0.5 x 10^9/L and platelets >= 50 x 10^9/L. There should not be evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution. CRh was calculated only for participants who were FLT3 mutation positive.
The analysis population was the FAS, with participants who were FLT3 mutation positive.
Posted
Number
95% Confidence Interval
percentage of participants
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Secondary
Percentage of Participants With Composite CR (CRc)
CRc was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRc when they had achieved either CR, complete remission with incomplete platelet recovery (CRp, defined as had achieved CR except for incomplete platelet recovery (< 100 x 10^9/L) or complete remission with incomplete hematologic recovery (CRi, defined as had fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery; RBC platelet transfusion independence not required). Exact 95% confidence interval was estimated using the binomial distribution.
The analysis population was the FAS.
Posted
Number
95% Confidence Interval
percentage of participants
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Secondary
Percentage of Participants With Partial Remission (PR)
PR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in PR when they had bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and with a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate with the total marrow blasts between 5% and 25%. A value of less or equal than 5% blasts was also considered a PR if Auer rods were present. There should be no evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution.
The analysis population was the FAS.
Posted
Number
95% Confidence Interval
percentage of participants
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Secondary
Percentage of Participants With Best Response
Best response was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). BR was defined as the best measured response for all visits (in the order of CR, CRp, CRi, and PR) post-treatment. Participants who achieved the best response of CR, CRp, CRi or PR were classified as responders. Participants who did not achieve at least PR were considered as non-responders. Exact 95% confidence interval was estimated using the binomial distribution.
The analysis population was the FAS.
Posted
Number
95% Confidence Interval
percentage of participants
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Percentage of Participants With Complete Remission and Complete Remission With Partial Hematologic Recovery (CR/CRh)
Participants with CR/CRh were defined as participants who achieved either CR or CRh. Participants with CR had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an ANC > 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, and normal marrow differential with < 5% blasts, had been RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). Also, there had been no presence of Auer rods, no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Participants with CRh could not be classified as being in CR and had bone marrow blasts < 5%, partial hematologic recovery ANC >= 0.5 x 10^9/L and platelets >= 50 x 10^9/L. There should not be evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution. CR/CRh was calculated only for participants who were FLT3 mutation positive.
The analysis population was the FAS, with participants who were FLT3 mutation positive.
Posted
Number
95% Confidence Interval
percentage of participants
Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Duration of CR (DCR)
DCR was defined as the time from the date of first CR until the date of documented relapse for participants who achieved CR. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study were considered non-events and censored at the last relapse-free disease assessment date. DCR was calculated using Kaplan-Meier method and therefore data are estimated.
The analysis population was the FAS. Only participants who achieved CR were included in the analysis.
Posted
Median
95% Confidence Interval
days
From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Secondary
Duration of CRp (DCRp)
DCRp was defined as the time from the date of first CRp until the date of documented relapse for participants who achieved CRp. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study were considered non-events and censored at the last relapse-free disease assessment date. DCRp was calculated using Kaplan-Meier method and therefore data are estimated.
The analysis population was the FAS. Only participants who achieved CRp were included in the analysis.
Posted
Median
95% Confidence Interval
days
From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Secondary
Duration of CRi (DCRi)
DCRi was defined as the time from the date of first CRi until the date of documented relapse for participants who achieved CRi. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRi was calculated using Kaplan-Meier method and therefore data are estimated.
The analysis population was the FAS. Only participants who achieved CRi were included in the analysis.
Posted
Median
95% Confidence Interval
days
From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Secondary
Duration of CRh (DCRh)
DCRh was defined as the time from the date of first CRh until the date of documented relapse for participants who achieved CRh but did not have a best response of CR. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRh was calculated using Kaplan-Meier method and therefore data are estimated. DCRh was calculated only for participants who were FLT3 mutation positive.
The analysis population was the FAS. Only participants who achieved CRh were included in the analysis.
Posted
Median
95% Confidence Interval
days
From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Secondary
Duration of CRc (DCRc)
DCRc was defined as the time from the date of first CRc until the date of documented relapse for participants who achieved CRc. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRc was calculated using Kaplan-Meier method and therefore data are estimated.
The analysis population was the FAS. Only participants who achieved CRc were included in the analysis.
Posted
Median
95% Confidence Interval
days
From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Secondary
Duration of CR/CRh (DCRCRh)
DCRCRh was defined as the time from the date of first DCRCRh until the date of documented relapse for participants who achieved CR or CRh. For participants who achieved both CR and CRh, the first CR date or CRh date, whichever occurred first, was used. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRCRh was calculated using Kaplan-Meier method and therefore data are estimated. DCRCRh was calculated only for participants who were FLT3 mutation positive.
The analysis population was the FAS. Only participants who achieved CR or CRh were included in the analysis.
Posted
Median
95% Confidence Interval
days
From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Duration of Response
Duration of response was defined as the time from the date of either first CRc or PR until the date of documented relapse of any type for participants who achieved CRc or PR. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study are considered non-events and censored at the last relapse-free assessment date. Duration of response was calculated using Kaplan-Meier method and therefore data are estimated.
The analysis population was the FAS. Only participants who achieved CRc or PR were included in the analysis.
Posted
Median
95% Confidence Interval
days
From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Time to CR (TTCR)
TTCR was defined as the time from the first dose of study drug until the date of first CR.
The analysis population was the FAS. Only participants who achieved CR were included in the analysis.
Posted
Median
Full Range
days
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Time to CRp (TTCRp)
TTCRp was defined as the time from the first dose of study drug until the date of first CRp. TTCRp was evaluated for participants who achieved CRp.
The analysis population was the FAS. Only participants who achieved CRp were included in the analysis.
Posted
Median
Full Range
days
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Time to CRi (TTCRi)
TTCRi was defined as the time from the first dose of study drug until the date of first CRi. TTCRi was evaluated for participants who achieved CRi.
The analysis population was the FAS. Only participants who achieved CRi were included in the analysis.
Posted
Median
Full Range
days
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Time to First CR/CRh (TTFCRCRh)
TTFCRCRh was defined as the time from the first dose of study drug until the date of first either CR or CRh. TTFCRCRh was evaluated for participants who achieved CR or CRh. For participants who achieve both CR and CRh, the first CR date or CRh date, whichever occurs first was used. TTFCRCRh was calculated only for participants who were FLT3 mutation positive.
The analysis population was the FAS. Only participants who achieved CR or CRh were included in the analysis.
Posted
Median
Full Range
days
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Secondary
Time to Best CR/CRh (TTBCRCRh)
TTBCRCRh was defined as the time from the first dose of study drug until the first date that the best response of CR or CRh was achieved. TTBCRCRh was evaluated for participants who achieved CR or CRh. For participants who achieve both CR and CRh, the first CR date was used. TTBCRCRh was calculated only for participants who were FLT3 mutation positive.
The analysis population was the FAS. Participants who achieved CR or CRh were included in the analysis.
Posted
Median
Full Range
days
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Secondary
Time to CRc (TTCRc)
TTCRc was defined as the time from the first dose of study drug until the date of first CRc. TTCRc was evaluated for participants who achieved CRc.
The analysis population was the FAS. Only participants who achieved CRc were included in the analysis.
Posted
Median
Full Range
days
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Time to Response (TTR)
TTR was defined as the time from the first dose of study drug until the date of either first CRc or PR. TTR was evaluated for participants who achieved CRc or PR.
The analysis population was the FAS. Only participants who achieved CRc or PR were included in the analysis.
Posted
Median
Full Range
days
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Time to Best Response (TTBR)
TTBR was defined as the time from the first dose of study drug until the first disease assessment date when participant achieved best response. TTBR was evaluated in participants who achieved best response of CR, CRp, CRi, or PR.
The analysis population was the FAS. Only participants who achieved CR, CRp, CRi, or PR were included in the analysis.
Posted
Median
Full Range
days
From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Overall Survival (OS)
The time from the date of first dose of study drug until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact. OS was calculated using Kaplan-Meier method and therefore data are estimated.
The analysis population was the FAS.
Posted
Median
95% Confidence Interval
days
From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Event Free Survival (EFS)
EFS was defined as the time from the date of first dose of study drug until the date of documented relapse, treatment failure or death from any cause, whichever occurred first. For a participant with none of these events, EFS was censored at the date of last relapse-free disease assessment. A participant without post-treatment disease assessment was censored at randomization date. Treatment failure included those participants who discontinued the treatment due to "progressive disease" or "lack of efficacy" without a previous response of CR, CRp, CRi or PR. Treatment failure date referred to the start of new anti-leukemia therapy or the last treatment evaluation date when new anti-leukemia therapy date was not available. For participants who were censored, last relapse-free disease assessment date referred to the participant's last disease assessment date. EFS was calculated using Kaplan-Meier method and therefore data are estimated.
The analysis population was the FAS.
Posted
Median
95% Confidence Interval
days
From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Secondary
Leukemia Free Survival (LFS)
LFS was defined as the time from the date of first CRc until the date of documented relapse or death for participants who achieved CRc. For a participant who was not known to have relapsed or died, LFS was censored on the date of last relapse-free disease assessment date. LFS was calculated using Kaplan-Meier method and therefore data are estimated.
The analysis population was the FAS. Only participants who achieved CRc were included in the analysis.
Posted
Median
95% Confidence Interval
days
From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Secondary
Percentage of Participants Who Achieved Transfusion Conversion
Participants who achieved transfusion conversion were defined as the number of participants who were transfusion dependent at baseline period but became transfusion independent at post-baseline period divided by the total number of participants who were transfusion dependent at baseline period. Participants were considered baseline transfusion dependent if there were RBC or platelet transfusions within the baseline period. Participants were considered post-baseline transfusion independent if they were on treatment >=84 days, and if there was one consecutive 56 days without any RBC or platelet transfusion within post-baseline period. If participants were on treatment >28 days but <84 days, and there was no RBC or platelet transfusion within post-baseline period, or on treatment <=28 days, post-baseline transfusion status was not evaluable. Exact 95% confidence interval was estimated using the binomial distribution.
The analysis population was the FAS. Participants who were transfusion dependent at baseline and had evaluable post-baseline transfusion status were included in the analysis.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (28 days prior to first dose until 28 days after the first dose) and postbaseline (from 29 days after first dose date until last dose date); median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
Percentage of Participants Who Achieved Transfusion Maintenance
Participants who achieved transfusion maintenance were defined as the number of participants who were transfusion independent at baseline period and still maintained transfusion independent at post-baseline period divided by the total number of participants who were transfusion independent at baseline period.
The analysis population was the FAS. Participants who were transfusion independent at baseline and had evaluable post-baseline transfusion status were included in the analysis.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (28 days prior to first dose until 28 days after the first dose) and postbaseline (from 29 days after first dose date until last dose date); median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days
ID
Title
Description
OG000
Gilteritinib 20 mg
Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Secondary
AUC24 of Gilteritinib in Co-administration With Voriconazole
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.
Posted
Mean
Standard Deviation
ng*h/mL
Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)
ID
Title
Description
OG000
Gilteritinib 20 mg in Expansion Phase
Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
Units
Counts
Participants
OG000
Secondary
Cmax of Gilteritinib in Co-administration With Voriconazole
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.
Posted
Mean
Standard Deviation
ng/mL
Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)
ID
Title
Description
OG000
Gilteritinib 20 mg in Expansion Phase
Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
Units
Counts
Participants
OG000
Secondary
AUClast of Gilteritinib in Co-administration With Voriconazole
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.
Posted
Mean
Standard Deviation
ng*h/mL
Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)
ID
Title
Description
OG000
Gilteritinib 20 mg in Expansion Phase
Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
Units
Counts
Participants
OG000
Secondary
Tmax of Gilteritinib in Co-administration With Voriconazole
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.
Posted
Median
Full Range
hours
Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)
ID
Title
Description
OG000
Gilteritinib 20 mg in Expansion Phase
Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
Units
Counts
Participants
OG000
Secondary
AUC24 of Midazolam Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.
Posted
Mean
Standard Deviation
ng*h/mL
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
ID
Title
Description
OG000
Gilteritinib 300 mg in Expansion Phase
Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Units
Counts
Participants
OG000
Secondary
AUC24 of Metabolite 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.
Posted
Mean
Standard Deviation
ng*h/mL
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
ID
Title
Description
OG000
Gilteritinib 300 mg in Expansion Phase
Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Units
Counts
Participants
OG000
Secondary
Cmax of Midazolam Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.
Posted
Mean
Standard Deviation
ng/mL
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
ID
Title
Description
OG000
Gilteritinib 300 mg in Expansion Phase
Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Units
Counts
Participants
OG000
Secondary
Cmax of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.
Posted
Mean
Standard Deviation
ng/mL
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
ID
Title
Description
OG000
Gilteritinib 300 mg in Expansion Phase
Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Units
Counts
Participants
OG000
Secondary
AUClast of Midazolam Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.
Posted
Mean
Standard Deviation
ng*h/mL
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
ID
Title
Description
OG000
Gilteritinib 300 mg in Expansion Phase
Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Units
Counts
Participants
OG000
Secondary
AUClast of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.
Posted
Mean
Standard Deviation
ng*h/mL
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
ID
Title
Description
OG000
Gilteritinib 300 mg in Expansion Phase
Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Units
Counts
Participants
OG000
Secondary
Tmax of Midazolam Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.
Posted
Median
Full Range
hours
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
ID
Title
Description
OG000
Gilteritinib 300 mg in Expansion Phase
Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Units
Counts
Participants
OG000
Secondary
Tmax of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.
Posted
Median
Full Range
hours
Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)
ID
Title
Description
OG000
Gilteritinib 300 mg in Expansion Phase
Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Units
Counts
Participants
OG000
Secondary
Area Under the Concentration-time Curve From the Time of Dosing Extrapolated to Time Infinity (AUCinf) of Cephalexin Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.
Posted
Mean
Standard Deviation
ng*h/mL
Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)
ID
Title
Description
OG000
Gilteritinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
Units
Counts
Participants
OG000
Secondary
Cmax of Cephalexin Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.
Posted
Mean
Standard Deviation
ng/mL
Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)
ID
Title
Description
OG000
Gilteritinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
Units
Counts
Participants
OG000
Secondary
AUClast of Cephalexin Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.
Posted
Mean
Standard Deviation
ng*h/mL
Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)
ID
Title
Description
OG000
Gilteritinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
Units
Counts
Participants
OG000
Secondary
Tmax of Cephalexin Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.
Posted
Median
Full Range
hours
Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)
ID
Title
Description
OG000
Gilteritinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
Units
Counts
Participants
OG000
Secondary
T1/2 of Cephalexin Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.
Posted
Mean
Standard Deviation
hours
Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)
ID
Title
Description
OG000
Gilteritinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
Units
Counts
Participants
OG000
Secondary
Apparent Total Systemic Clearance After Single or Multiple Extravascular Dosing (CL/F) of Cephalexin Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.
Posted
Mean
Standard Deviation
L/h
Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)
ID
Title
Description
OG000
Gilteritinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
Units
Counts
Participants
OG000
Secondary
Apparent Volume of Distribution During the Terminal Elimination Phase After Single Extravascular Dosing (Vz/F) of Cephalexin Administered With and Without Gilteritinib
Plasma samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.
Posted
Mean
Standard Deviation
liters
Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)
ID
Title
Description
OG000
Gilteritinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
Units
Counts
Participants
OG000
Secondary
Amount of Drug Excreted in Urine (Aelast) of Cephalexin Administered With and Without Gilteritinib
Urine samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.
Posted
Mean
Standard Deviation
mg
Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)
ID
Title
Description
OG000
Gilteritinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
Units
Counts
Participants
OG000
Secondary
Fraction of Drug Excreted Into Urine in Percentage (%Ae) of Cephalexin Administered With and Without Gilteritinib
Urine samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.
Posted
Mean
Standard Deviation
percentage
Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)
ID
Title
Description
OG000
Gilteritinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
Units
Counts
Participants
OG000
Secondary
Renal Clearance (CLr) of Cephalexin in Administered With and Without Gilteritinib
Urine samples were used for pharmacokinetic assessments.
The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.
Posted
Mean
Standard Deviation
L/h
Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)
ID
Title
Description
OG000
Gilteritinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
Units
Counts
Participants
OG000
Time Frame
From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)
Description
The total number of deaths (all causes) includes deaths reported after the time frame above.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Gilterinib 20 mg in Escalation Phase
Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
4
5
2
5
5
5
EG001
Gilterinib 40 mg in Escalation Phase
Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
2
3
2
3
2
3
EG002
Gilterinib 80 mg in Escalation Phase
Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
3
3
2
3
3
3
EG003
Gilterinib 120 mg in Escalation Phase
Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
3
3
1
3
3
3
EG004
Gilterinib 200 mg in Escalation Phase
Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
2
3
2
3
3
3
EG005
Gilterinib 300 mg in Escalation Phase
Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
3
3
2
3
3
3
EG006
Gilterinib 450 mg in Escalation Phase
Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
3
3
2
3
3
3
EG007
Gilterinib 20 mg in Expansion Phase
Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
10
12
8
12
12
12
EG008
Gilterinib 40 mg in Expansion Phase
Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
13
13
12
13
12
13
EG009
Gilterinib 80 mg in Expansion Phase
Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
21
21
19
21
20
21
EG010
Gilterinib 120 mg in Expansion Phase
Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
53
66
52
66
62
66
EG011
Gilterinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
82
100
92
100
97
100
EG012
Gilterinib 300 mg in Expansion Phase
Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
16
17
14
17
16
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected13 at risk
EG0091 events1 affected21 at risk
EG0100 events0 affected66 at risk
EG0116 events4 affected100 at risk
EG0120 events0 affected17 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 20
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Atrial thrombosis
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diabetes insipidus
Endocrine disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctival oedema
Eye disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Papilloedema
Eye disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Large intestinal ulcer
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Malabsorption
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenic colitis
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rectal tenesmus
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Death
General disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sudden death
General disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute graft versus host disease
Immune system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute graft versus host disease in intestine
Immune system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute graft versus host disease in skin
Immune system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chronic graft versus host disease in skin
Immune system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Graft versus host disease in skin
Immune system disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 20
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Clostridial infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Clostridium bacteraemia
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Device related infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Encephalitis viral
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Enterococcal infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Epiglottitis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fungaemia
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hepatic infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Lung infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oral infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Periorbital infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia haemophilus
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia parainfluenzae viral
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Post procedural cellulitis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pseudomonas infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Septic shock
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sinusitis fungal
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin bacterial infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Streptococcal sepsis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Systemic candida
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Systemic mycosis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Toxic shock syndrome
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection enterococcal
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Liver function test increased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Transaminases increased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Troponin I increased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
White blood cell count increased
Investigations
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Necrotising myositis
Musculoskeletal and connective tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20
Systematic Assessment
EG0001 events1 affected5 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute myeloid leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Central nervous system leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
BG00519.75± NAData could not be calculated as there is only one participant in this arm who had available data.
BG0067.21± 4.27
BG00711.3± 6.61
BG00810.53± 11.22
BG00916.3± 9.85
BG01012.65± 11.33
BG01110.9± 9.94
BG01212.09± 17.76
BG01313.16± 14.97
3
ParticipantsBG0033
ParticipantsBG0043
ParticipantsBG0053
ParticipantsBG0063
ParticipantsBG00712
ParticipantsBG00813
ParticipantsBG00921
ParticipantsBG01066
ParticipantsBG011100
ParticipantsBG01217
ParticipantsBG013252
Title
Measurements
Negative
BG0001
BG0010
BG0020
BG0031
BG0041
BG0051
BG0061
BG0071
BG0088
BG00912
BG01013
BG01110
BG0129
BG01358
Positive
BG0004
BG0013
BG0023
BG0032
BG004
OG005
Gilteritinib 300 mg in Escalation Phase
Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG006
Gilteritinib 450 mg in Escalation Phase
Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG007
Gilteritinib 20 mg in Expansion Phase
Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
OG008
Gilteritinib 40 mg in Expansion Phase
Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
OG009
Gilteritinib 80 mg in Expansion Phase
Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
OG010
Gilteritinib 120 mg in Expansion Phase
Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
OG011
Gilteritinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
OG012
Gilteritinib 300 mg in Expansion Phase
Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
3
OG0043
OG0053
OG0063
OG0079
OG00811
OG00918
OG01062
OG01187
OG01213
0
OG0040
OG0050
OG0062
OG0071
OG0081
OG0092
OG0107
OG01115
OG0123
Blood and lymphatic system disorders
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0121
Cardiac disorders
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
OG0120
Eye disorders
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0100
OG0110
OG0120
Gastrointestinal disorders
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
OG0101
OG0114
OG0121
General disorders & administration site conditions
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0111
OG0120
Hepatobiliary disorders
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
OG0120
Infections and infestations
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
OG0091
OG0100
OG0110
OG0120
Investigations
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
OG0102
OG0116
OG0122
Metabolism and nutrition disorders
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0112
OG0120
Musculoskeletal and connective tissue disorders
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0111
OG0121
Nervous system disorders
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
OG0113
OG0120
Renal and urinary disorders
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
OG0120
Reproductive system and breast disorders
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0111
OG0120
Respiratory, thoracic and mediastinal disorders
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0112
OG0121
Vascular disorders
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0112
OG0121
OG001
Gilteritinib 40 mg in Escalation Phase
Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG002
Gilteritinib 80 mg in Escalation Phase
Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG003
Gilteritinib 120 mg in Escalation Phase
Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG004
Gilteritinib 200 mg in Escalation Phase
Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG005
Gilteritinib 300 mg in Escalation Phase
Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG006
Gilteritinib 450 mg in Escalation Phase
Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG007
Gilteritinib 20 mg in Expansion Phase
Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.
OG008
Gilteritinib 40 mg in Expansion Phase
Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
OG009
Gilteritinib 80 mg in Expansion Phase
Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
OG010
Gilteritinib 120 mg in Expansion Phase
Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.
OG011
Gilteritinib 200 mg in Expansion Phase
Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.
OG012
Gilteritinib 300 mg in Expansion Phase
Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.
Units
Counts
Participants
OG0005
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG00712
OG00813
OG00921
OG01066
OG011100
OG01217
Title
Denominators
Categories
AEs
Title
Measurements
OG0005
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG00712
OG00813
OG00920
OG01064
OG011100
OG01217
Drug-Related AEs
Title
Measurements
OG0003
OG0012
OG0021
OG003
Deaths
Title
Measurements
OG0002
OG0012
OG0020
OG003
Serious AEs
Title
Measurements
OG0002
OG0012
OG0022
OG003
Drug-Related Serious AEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
AEs Leading to Discontinuation of Study Drug
Title
Measurements
OG0002
OG0010
OG0021
OG003
Drug-Related AEs Leading to Discont. of Study Drug
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 or Higher TEAEs
Title
Measurements
OG0003
OG0012
OG0022
OG003
AEs During On-Study HSCT Period
Title
Measurements
OG0000
OG0010
OG0020
OG003
Serious AEs During On-Study HSCT
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Gilteritinib 80 mg in Escalation Phase
Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG003
Gilteritinib 120 mg in Escalation Phase
Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG004
Gilteritinib 200 mg in Escalation Phase
Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG005
Gilteritinib 300 mg in Escalation Phase
Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG006
Gilteritinib 450 mg in Escalation Phase
Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Units
Counts
Participants
OG0005
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
Title
Denominators
Categories
Day -2
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0062
Title
Measurements
OG000302.1± 207.0
OG001360.0± 223.5
OG0021216± 472.6
OG003
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.
Slope
0.990
2-Sided
90
0.788
1.19
Other
OG000
OG001
OG002
OG003
OG004
OG005
OG006
Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.
Slope
1.22
2-Sided
90
1.00
1.43
Other
OG003
Gilteritinib 120 mg in Escalation Phase
Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG004
Gilteritinib 200 mg in Escalation Phase
Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG005
Gilteritinib 300 mg in Escalation Phase
Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG006
Gilteritinib 450 mg in Escalation Phase
Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Units
Counts
Participants
OG0005
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
Title
Denominators
Categories
Day -2
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
Title
Measurements
OG00028.13± 21.49
OG00124.98± 14.58
OG00275.29± 25.22
OG003
Cycle 1 day 15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.
Slope
0.808
2-Sided
90
0.629
0.988
Other
OG000
OG001
OG002
OG003
OG004
OG005
OG006
Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.
Slope
1.21
2-Sided
90
1.02
1.41
Other
Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG003
Gilteritinib 120 mg in Escalation Phase
Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG004
Gilteritinib 200 mg in Escalation Phase
Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG005
Gilteritinib 300 mg in Escalation Phase
Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG006
Gilteritinib 450 mg in Escalation Phase
Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Units
Counts
Participants
OG0005
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
Title
Denominators
Categories
Day -2
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
Title
Measurements
OG000303.0± 207.1
OG001360.4± 224.1
OG0021216± 472.6
OG003
Cycle 1 day -15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
OG003
Gilteritinib 120 mg in Escalation Phase
Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG004
Gilteritinib 200 mg in Escalation Phase
Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG005
Gilteritinib 300 mg in Escalation Phase
Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG006
Gilteritinib 450 mg in Escalation Phase
Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Units
Counts
Participants
OG0005
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
Title
Denominators
Categories
Day -2
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
Title
Measurements
OG0002.00(0.500 to 4.03)
OG0015.983(3.97 to 24.0)
OG0024.000(4.00 to 4.08)
OG003
Cycle 1 day 15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
OG003
Gilteritinib 120 mg in Escalation Phase
Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG004
Gilteritinib 200 mg in Escalation Phase
Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG005
Gilteritinib 300 mg in Escalation Phase
Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG006
Gilteritinib 450 mg in Escalation Phase
Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Units
Counts
Participants
OG0003
OG0012
OG0023
OG0033
OG0042
OG0053
OG0060
Title
Denominators
Categories
Title
Measurements
OG00062.14± 17.88
OG001151.8± 129.2
OG00286.11± 24.08
OG00345.85± 18.83
OG004141.9± 61.51
OG005142.2± 55.04
OG003
Gilteritinib 120 mg in Escalation Phase
Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG004
Gilteritinib 200 mg in Escalation Phase
Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG005
Gilteritinib 300 mg in Escalation Phase
Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
OG006
Gilteritinib 450 mg in Escalation Phase
Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in in the escalation phase of the study.28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.
Units
Counts
Participants
OG0003
OG0012
OG0023
OG0033
OG0042
OG0053
OG0060
Title
Denominators
Categories
Title
Measurements
OG0004.259± 1.069
OG0019.640± 7.754
OG0025.693± 1.442
OG0033.290± 1.118
OG0049.041± 3.693
OG0059.057± 3.303
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG00016
OG00116
OG00224
OG00370
OG004100
OG00520
OG0063
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG00014
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00356
ParticipantsOG00489
ParticipantsOG00510
ParticipantsOG0062
Title
Measurements
OG0000(NA to NA)Data could not be calculated due to the low number of events.
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG0028.3(0.2 to 38.5)
OG003
FLT3 Mutation Negative
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00314
All Participants
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00224
ParticipantsOG00370
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG00016
OG00116
OG00224
OG00370
OG004100
OG00520
OG0063
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG00014
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00356
ParticipantsOG00489
ParticipantsOG00510
ParticipantsOG0062
Title
Measurements
OG0000(NA to NA)Data could not be calculated due to the low number of events.
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG00216.7(2.1 to 48.4)
OG003
FLT3 Mutation Negative
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00314
All Participants
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00224
ParticipantsOG00370
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG00016
OG00116
OG00224
OG00370
OG004100
OG00520
OG0063
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG00014
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00356
ParticipantsOG00489
ParticipantsOG00510
ParticipantsOG0062
Title
Measurements
OG0000(NA to NA)Data could not be calculated due to the low number of events.
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG0020(NA to NA)Data could not be calculated due to the low number of events.
OG003
FLT3 Mutation Negative
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00314
All Participants
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00224
ParticipantsOG00370
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG00016
OG00116
OG00224
OG00370
OG004100
OG00520
OG0063
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG00014
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00356
ParticipantsOG00489
ParticipantsOG00510
ParticipantsOG0062
Title
Measurements
OG0007.1(0.2 to 33.9)
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG00225.0(5.5 to 57.2)
OG003
FLT3 Mutation Negative
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00314
All Participants
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00224
ParticipantsOG00370
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG00014
OG0018
OG00212
OG00356
OG00489
OG00510
OG0062
Title
Denominators
Categories
Title
Measurements
OG0007.1(0.2 to 33.9)
OG0010(0 to 0)
OG0028.3(0.2 to 38.5)
OG00310.7(4.0 to 21.9)
OG0047.9(3.2 to 15.5)
OG00520.0(2.5 to 55.6)
OG0060(0 to 0)
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG00016
OG00116
OG00224
OG00370
OG004100
OG00520
OG0063
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG00014
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00356
ParticipantsOG00489
ParticipantsOG00510
ParticipantsOG0062
Title
Measurements
OG0007.1(0.2 to 33.9)
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG00241.7(15.2 to 72.3)
OG003
FLT3 Mutation Negative
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00314
All Participants
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00224
ParticipantsOG00370
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG00016
OG00116
OG00224
OG00370
OG004100
OG00520
OG0063
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG00014
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00356
ParticipantsOG00489
ParticipantsOG00510
ParticipantsOG0062
Title
Measurements
OG0007.1(0.2 to 33.9)
OG00137.5(8.5 to 75.5)
OG00225.0(5.5 to 57.2)
OG003
FLT3 Mutation Negative
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00314
All Participants
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00224
ParticipantsOG00370
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG00016
OG00116
OG00224
OG00370
OG004100
OG00520
OG0063
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG00014
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00356
ParticipantsOG00489
ParticipantsOG00510
ParticipantsOG0062
Title
Measurements
OG00014.3(1.8 to 42.8)
OG00137.5(8.5 to 75.5)
OG00266.7(34.9 to 90.1)
OG003
FLT3 Mutation Negative
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00314
All Participants
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00224
ParticipantsOG00370
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG00014
OG0018
OG00212
OG00356
OG00489
OG00510
OG0062
Title
Denominators
Categories
Title
Measurements
OG0007.1(0.2 to 33.9)
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG00225.0(5.5 to 57.2)
OG00323.2(13.0 to 36.4)
OG00419.1(11.5 to 28.8)
OG00530.0(6.7 to 65.2)
OG0060(NA to NA)Data could not be calculated due to the low number of events.
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0001
OG0010
OG0022
OG0037
OG00410
OG0051
OG0060
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0037
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG002NA(NA to NA)Data could not be calculated due to the low number of events.
OG003NA(86.0 to NA)Data could not be calculated due to the low number of events.
OG004419.0(64.0 to NA)Data could not be calculated due to the low number of events.
OG005
FLT3 Mutation Negative
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
All Participants
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0037
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0036
OG00412
OG0052
OG0060
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0036
ParticipantsOG00412
ParticipantsOG0052
ParticipantsOG0060
Title
Measurements
OG002NA(NA to NA)Data could not be calculated due to the low number of events.
OG003NA(57.0 to NA)Data could not be calculated due to the low number of events.
OG004450.0(43.0 to NA)Data could not be calculated due to the low number of events.
OG005
FLT3 Mutation Negative
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
All Participants
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0036
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0001
OG0010
OG0027
OG00324
OG00431
OG0051
OG0060
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG00323
ParticipantsOG00430
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG000NA(NA to NA)Data could not be calculated due to the low number of events.
OG002NA(79.0 to NA)Data could not be calculated due to the low number of events.
OG003120.0(56.0 to 383.0)
OG004
FLT3 Mutation Negative
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
All Participants
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0027
ParticipantsOG00324
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0036
OG0047
OG0052
OG0060
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data could not be calculated due to the low number of events.
OG002NA(NA to NA)Data could not be calculated due to the low number of events.
OG00364.0(18.0 to 85.0)
OG004101.0(29.0 to NA)Data could not be calculated due to the low number of events.
OG005NA(NA to NA)Data could not be calculated due to the low number of events.
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0002
OG0010
OG0027
OG00327
OG00437
OG0053
OG0060
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG00326
ParticipantsOG00436
ParticipantsOG0053
ParticipantsOG0060
Title
Measurements
OG000NA(NA to NA)Data could not be calculated due to the low number of events.
OG002NA(79.0 to NA)Data could not be calculated due to the low number of events.
OG00398.0(57.0 to 307.0)
OG004
FLT3 Mutation Negative
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
All Participants
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0027
ParticipantsOG00327
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0001
OG0010
OG0023
OG00313
OG00417
OG0053
OG0060
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data could not be calculated due to the low number of events.
OG002NA(NA to NA)Data could not be calculated due to the low number of events.
OG003307.0(56.0 to NA)Data could not be calculated due to the low number of events.
OG004308.0(101.0 to NA)Data could not be calculated due to the low number of events.
OG005NA(NA to NA)Data could not be calculated due to the low number of events.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0003
OG0013
OG00210
OG00332
OG00445
OG0056
OG0061
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG00330
ParticipantsOG00443
ParticipantsOG0056
ParticipantsOG0061
Title
Measurements
OG000NA(NA to NA)Data could not be calculated due to the low number of events.
OG001NA(NA to NA)Data could not be calculated due to the low number of events.
OG00288.0(9.0 to NA)Data could not be calculated due to the low number of events.
OG003
FLT3 Mutation Negative
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
All Participants
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG00332
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0001
OG0010
OG0022
OG0037
OG00410
OG0051
OG0060
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0037
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG002171.5(28 to 315)
OG003141.0(29 to 364)
OG00493.0(27 to 225)
OG005
FLT3 Mutation Negative
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
All Participants
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0037
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0036
OG00412
OG0052
OG0060
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0036
ParticipantsOG00412
ParticipantsOG0052
ParticipantsOG0060
Title
Measurements
OG002140.0(140 to 140)
OG003195.0(30 to 418)
OG00484.5(28 to 392)
OG005
FLT3 Mutation Negative
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
All Participants
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0036
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0001
OG0010
OG0027
OG00324
OG00431
OG0051
OG0060
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG00323
ParticipantsOG00430
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG00057.0(57 to 57)
OG00257.0(31 to 70)
OG00357.0(26 to 170)
OG004
FLT3 Mutation Negative
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
All Participants
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0027
ParticipantsOG00324
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0001
OG0010
OG0023
OG00313
OG00417
OG0053
OG0060
Title
Denominators
Categories
Title
Measurements
OG00057.0(57 to 57)
OG00257.0(28 to 140)
OG00359.0(29 to 280)
OG00457.0(27 to 245)
OG00528.0(28 to 30)
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0001
OG0010
OG0023
OG00313
OG00417
OG0053
OG0060
Title
Denominators
Categories
Title
Measurements
OG00057.0(57 to 57)
OG00257.0(28 to 315)
OG00363.0(29 to 364)
OG00488.0(27 to 245)
OG00530.0(28 to 56)
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0002
OG0010
OG0027
OG00327
OG00437
OG0053
OG0060
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG00326
ParticipantsOG00436
ParticipantsOG0053
ParticipantsOG0060
Title
Measurements
OG00057.0(57 to 57)
OG00256.0(28 to 64)
OG00330.0(26 to 211)
OG004
FLT3 Mutation Negative
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
All Participants
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0027
ParticipantsOG00327
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0003
OG0013
OG00210
OG00332
OG00445
OG0056
OG0061
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG00330
ParticipantsOG00443
ParticipantsOG0056
ParticipantsOG0061
Title
Measurements
OG00061.5(29 to 94)
OG00157.0(31 to 64)
OG00231.0(28 to 59)
OG003
FLT3 Mutation Negative
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
All Participants
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG00332
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0003
OG0013
OG00210
OG00332
OG00445
OG0056
OG0061
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG00330
ParticipantsOG00443
ParticipantsOG0056
ParticipantsOG0061
Title
Measurements
OG00075.5(57 to 94)
OG00157.0(31 to 64)
OG00244.0(28 to 315)
OG003
FLT3 Mutation Negative
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
All Participants
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00210
ParticipantsOG00332
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG00016
OG00116
OG00224
OG00370
OG004100
OG00520
OG0063
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG00014
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00356
ParticipantsOG00489
ParticipantsOG00510
ParticipantsOG0062
Title
Measurements
OG000123.0(17.0 to 267.0)
OG001199.5(56.0 to 905.0)
OG002197.5(61.0 to 329.0)
OG003
FLT3 Mutation Negative
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00314
All Participants
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00224
ParticipantsOG00370
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG00016
OG00116
OG00224
OG00370
OG004100
OG00520
OG0063
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG00014
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00356
ParticipantsOG00489
ParticipantsOG00510
ParticipantsOG0062
Title
Measurements
OG00052.0(14.0 to 88.0)
OG001109.0(29.0 to 357.0)
OG00293.5(61.0 to 127.0)
OG003
FLT3 Mutation Negative
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00314
All Participants
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00224
ParticipantsOG00370
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0002
OG0010
OG0027
OG00327
OG00437
OG0053
OG0060
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG00326
ParticipantsOG00436
ParticipantsOG0053
ParticipantsOG0060
Title
Measurements
OG000242.0(NA to NA)Data could not be calculated due to the low number of events.
OG00298.0(56.0 to 1126.0)
OG00398.0(58.0 to 187.0)
OG004
FLT3 Mutation Negative
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
All Participants
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0027
ParticipantsOG00327
OG001
Gilteritinib 40 mg
Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0007
OG0018
OG00216
OG00349
OG00463
OG0058
OG0062
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0028
ParticipantsOG00340
ParticipantsOG00457
ParticipantsOG0054
ParticipantsOG0061
Title
Measurements
OG0000(NA to NA)No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.
OG0010(NA to NA)No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.
OG00237.5(8.5 to 75.5)
OG003
FLT3 Mutation Negative
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0039
All Participants
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG00216
ParticipantsOG00349
OG002
Gilteritinib 80 mg
Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG003
Gilteritinib 120 mg
Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG004
Gilteritinib 200 mg
Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG005
Gilteritinib 300 mg
Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
OG006
Gilteritinib 450 mg
Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0037
OG00410
OG0050
OG0061
Title
Denominators
Categories
FLT3 Mutation Positive
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0034
ParticipantsOG00410
ParticipantsOG0050
ParticipantsOG0061
Title
Measurements
OG002100.0(2.5 to 100)
OG00375.0(19.4 to 99.4)
OG00480.0(44.4 to 97.5)
OG006
FLT3 Mutation Negative
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0033
All Participants
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0037
1
Title
Denominators
Categories
Title
Measurements
OG000919.3± NASD could not be calculated due to a sample size of 1.
1
Title
Denominators
Categories
Title
Measurements
OG00063.79± NASD could not be calculated due to a sample size of 1.
1
Title
Denominators
Categories
Title
Measurements
OG000919.3± NASD could not be calculated due to a sample size of 1.
1
Title
Denominators
Categories
Title
Measurements
OG0002.08(2.08 to 2.08)
17
Title
Denominators
Categories
Midazolam Alone (Day -1)
ParticipantsOG00015
Title
Measurements
OG00066.55± 57.70
Midazolam + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG0008
Title
Measurements
OG00081.56± 65.84
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of least squares (LS) means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.
Geometric LS Mean Ratio
109.46
2-Sided
90
49.82
240.48
Other
17
Title
Denominators
Categories
Midazolam Alone (Day -1)
ParticipantsOG00015
Title
Measurements
OG00020.44± 24.80
Midazolam + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG0008
Title
Measurements
OG00023.10± 21.64
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam alone and 1-hydroxymidazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.
Geometric LS Mean Ratio
149.90
90
74.88
300.06
Other
17
Title
Denominators
Categories
Midazolam Alone (Day -1)
ParticipantsOG00016
Title
Measurements
OG00014.68± 8.923
Midazolam + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG0009
Title
Measurements
OG00018.45± 9.452
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.
Geometric LS Mean Ratio
111.64
2-Sided
90
69.54
179.25
Other
17
Title
Denominators
Categories
Midazolam Alone (Day -1)
ParticipantsOG00016
Title
Measurements
OG0004.562± 2.858
Midazolam + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG0009
Title
Measurements
OG0005.053± 3.158
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam/midazolam alone and 1-hydroxymidazolam/midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.
Geometric LS Mean Ratio
123.47
2-Sided
90
72.41
210.52
Other
17
Title
Denominators
Categories
Midazolam Alone (Day -1)
ParticipantsOG00016
Title
Measurements
OG00059.48± 59.49
Midazolam + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG0009
Title
Measurements
OG00082.44± 64.25
17
Title
Denominators
Categories
Midazolam Alone (Day -1)
ParticipantsOG00016
Title
Measurements
OG00017.05± 24.70
Midazolam + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG0009
Title
Measurements
OG00023.58± 22.07
17
Title
Denominators
Categories
Midazolam Alone (Day -1)
ParticipantsOG00016
Title
Measurements
OG0000.5000(0.367 to 2.00)
Midazolam + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG0009
Title
Measurements
OG0001.00(0.317 to 4.13)
17
Title
Denominators
Categories
Midazolam Alone (Day -1)
ParticipantsOG00016
Title
Measurements
OG0000.5583(0.483 to 2.00)
Midazolam + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG0009
Title
Measurements
OG0001.00(0.317 to 4.13)
100
Title
Denominators
Categories
Cephalexin Alone (Day -1)
ParticipantsOG00018
Title
Measurements
OG00057650± 20386
Cephalexin + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG00013
Title
Measurements
OG00051873± 18819
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.
Geometric LS Mean Ratio
93.96
2-Sided
90
75.29
117.26
Other
100
Title
Denominators
Categories
Cephalexin Alone (Day -1)
ParticipantsOG00020
Title
Measurements
OG00017688± 6680
Cephalexin + Gilteritinib (Cycle 1 day 15)
ParticipantsOG00016
Title
Measurements
OG00016075± 4606
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.
Geometric LS Mean Ratio
91.46
2-Sided
90
74.60
112.12
Other
100
Title
Denominators
Categories
Cephalexin Alone (Day -1)
ParticipantsOG00020
Title
Measurements
OG00053183± 26877
Cephalexin + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG00016
Title
Measurements
OG00054963± 29531
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.
Geometric LS Mean Ratio
97.71
2-Sided
90
74.19
128.70
Other
100
Title
Denominators
Categories
Cephalexin Alone (Day -1)
ParticipantsOG00020
Title
Measurements
OG0001.500(1.00 to 4.02)
Cephalexin + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG00016
Title
Measurements
OG0001.483(1.00 to 5.88)
100
Title
Denominators
Categories
Cephalexin Alone (Day -1)
ParticipantsOG00018
Title
Measurements
OG0001.822± 0.5914
Cephalexin + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG00013
Title
Measurements
OG0001.827± 0.7175
100
Title
Denominators
Categories
Cephalexin Alone (Day -1)
ParticipantsOG00018
Title
Measurements
OG0009.713± 3.319
Cephalexin + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG00013
Title
Measurements
OG00010.58± 2.977
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.
Geometric LS Mean Ratio
106.42
2-Sided
90
85.28
132.81
Other
100
Title
Denominators
Categories
Cephalexin Alone (Day -1)
ParticipantsOG00018
Title
Measurements
OG00024.07± 7.173
Cephalexin + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG00013
Title
Measurements
OG00025.86± 5.346
100
Title
Denominators
Categories
Cephalexin Alone (Day -1)
ParticipantsOG00013
Title
Measurements
OG000548.9± 523.7
Cephalexin + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG00010
Title
Measurements
OG000448.8± 306.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.
Geometric LS Mean Ratio
83.93
2-Sided
90
46.53
151.39
Other
100
Title
Denominators
Categories
Cephalexin Alone (Day -1)
ParticipantsOG00013
Title
Measurements
OG000109.8± 104.7
Cephalexin + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG00010
Title
Measurements
OG00089.75± 61.21
100
Title
Denominators
Categories
Cephalexin Alone (Day -1)
ParticipantsOG00013
Title
Measurements
OG0008.784± 8.727
Cephalexin + Gilteritinib (Cycle 1 Day 15)
ParticipantsOG0006
Title
Measurements
OG00011.04± 8.430
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.
Geometric LS Mean Ratio
82.84
2-Sided
90
40.25
170.48
Other
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected13 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected66 at risk
EG0111 events1 affected100 at risk
EG0121 events1 affected17 at risk
1 events
1 affected
3 at risk
EG0046 events2 affected3 at risk
EG0055 events2 affected3 at risk
EG0060 events0 affected3 at risk
EG0076 events4 affected12 at risk
EG0087 events7 affected13 at risk
EG00911 events5 affected21 at risk
EG01028 events18 affected66 at risk
EG01158 events35 affected100 at risk
EG0124 events4 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected13 at risk
EG0091 events1 affected21 at risk
EG0100 events0 affected66 at risk
EG0110 events0 affected100 at risk
EG0120 events0 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected13 at risk
EG0090 events0 affected21 at risk
EG0102 events2 affected66 at risk
EG0113 events3 affected100 at risk
EG0121 events1 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected13 at risk
EG0090 events0 affected21 at risk
EG0102 events1 affected66 at risk
EG0112 events2 affected100 at risk
EG0120 events0 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected13 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected66 at risk
EG0112 events2 affected100 at risk
EG0120 events0 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected13 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected66 at risk
EG0112 events2 affected100 at risk
EG0120 events0 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected13 at risk
EG0091 events1 affected21 at risk
EG0100 events0 affected66 at risk
EG0111 events1 affected100 at risk
EG0120 events0 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected13 at risk
EG0090 events0 affected21 at risk
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EG0100 events0 affected66 at risk
EG01112 events7 affected100 at risk
EG0120 events0 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected12 at risk
EG0081 events1 affected13 at risk
EG0090 events0 affected21 at risk
EG01011 events11 affected66 at risk
EG01113 events11 affected100 at risk
EG0120 events0 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected12 at risk
EG0081 events1 affected13 at risk
EG0091 events1 affected21 at risk
EG0103 events3 affected66 at risk
EG0119 events7 affected100 at risk
EG0120 events0 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected12 at risk
EG0082 events1 affected13 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected66 at risk
EG0110 events0 affected100 at risk
EG0121 events1 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected13 at risk
EG0091 events1 affected21 at risk
EG0101 events1 affected66 at risk
EG0115 events5 affected100 at risk
EG0124 events2 affected17 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected13 at risk
EG0090 events0 affected21 at risk
EG0102 events2 affected66 at risk
EG0110 events0 affected100 at risk
EG0120 events0 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected12 at risk
EG0080 events0 affected13 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected66 at risk
EG0111 events1 affected100 at risk
EG0121 events1 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected12 at risk
EG0080 events0 affected13 at risk
EG0091 events1 affected21 at risk
EG0102 events2 affected66 at risk
EG0118 events6 affected100 at risk
EG0120 events0 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected13 at risk
EG0090 events0 affected21 at risk
EG0102 events2 affected66 at risk
EG0112 events2 affected100 at risk
EG0120 events0 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected12 at risk
EG0081 events1 affected13 at risk
EG0091 events1 affected21 at risk
EG0107 events7 affected66 at risk
EG01134 events16 affected100 at risk
EG0122 events1 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected12 at risk
EG0080 events0 affected13 at risk
EG0094 events3 affected21 at risk
EG01011 events10 affected66 at risk
EG01132 events25 affected100 at risk
EG0121 events1 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected13 at risk
EG0092 events1 affected21 at risk
EG0103 events3 affected66 at risk
EG0118 events8 affected100 at risk
EG0120 events0 affected17 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected12 at risk
EG0080 events0 affected13 at risk
EG0092 events2 affected21 at risk
EG0101 events1 affected66 at risk
EG0110 events0 affected100 at risk
EG0120 events0 affected17 at risk
1
BG0052
BG0063
BG0074
BG0089
BG0099
BG01029
BG01151
BG01212
BG013129
1
BG0053
BG0063
BG00710
BG0089
BG00914
BG01057
BG01191
BG01213
BG013213
1
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
BG0114
BG0120
BG0137
0
BG0050
BG0060
BG0071
BG0084
BG0093
BG0106
BG0111
BG0121
BG01316
0
BG0050
BG0060
BG0071
BG0081
BG0091
BG0104
BG0113
BG0120
BG01311
2
BG0052
BG0062
BG00711
BG0085
BG0099
BG01053
BG01190
BG0128
BG013194
3
OG0043
OG0052
OG0063
OG0077
OG0086
OG00917
OG01052
OG01177
OG01213
1
OG0041
OG0051
OG0061
OG0073
OG0084
OG00911
OG01023
OG01149
OG0127
1
OG0042
OG0052
OG0062
OG0078
OG00812
OG00919
OG01052
OG01192
OG01214
1
OG0041
OG0050
OG0062
OG0072
OG0081
OG00910
OG01019
OG01136
OG0124
0
OG0041
OG0050
OG0061
OG0072
OG0085
OG00911
OG01012
OG01146
OG0126
0
OG0040
OG0050
OG0060
OG0071
OG0081
OG0094
OG0105
OG01110
OG0123
1
OG0042
OG0052
OG0063
OG0079
OG00813
OG00920
OG01059
OG01199
OG01214
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0103
OG0117
OG0120
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0113
OG0120
2480
± 1972
OG0043022± 843.6
OG0054163± 3178
OG0063324± 221.1
Participants
OG004
2
ParticipantsOG0053
ParticipantsOG0061
Title
Measurements
OG0001299± 1006
OG0012482± 33.28
OG0026958± 3273
OG0036943± 3221
OG00431428± 21412
OG00531005± 10068
OG00634768± NAThis cannot be calculated due to insufficient data (only 1 participant had available data).
136.7
± 94.37
OG004168.2± 45.34
OG005204.3± 136.4
OG006207.6± 51.81
Participants
OG004
2
ParticipantsOG0053
ParticipantsOG0061
Title
Measurements
OG00064.64± 48.77
OG001107.6± 31.92
OG002376.4± 150.5
OG003374.2± 190.1
OG0041462± 815.1
OG0051525± 664.6
OG0061528± NAThis cannot be calculated due to insufficient data (only 1 participant had available data).
2480
± 1972
OG0043024± 846.2
OG0054181± 3189
OG0062544± 1427
Participants
OG004
2
ParticipantsOG0053
ParticipantsOG0061
Title
Measurements
OG0001030± 984.2
OG0011990± 1422
OG0027111± 3525
OG0036943± 3221
OG00432248± 22571
OG00531749± 10090
OG00635506± NAThis cannot be calculated due to insufficient data (only 1 participant had available data).
2.083
(2.00 to 3.83)
OG0045.233(4.00 to 5.97)
OG0056.067(4.08 to 24.1)
OG0065.783(4.08 to 5.92)
Participants
OG004
2
ParticipantsOG0053
ParticipantsOG0061
Title
Measurements
OG0004.008(4.00 to 6.00)
OG0013.867(0.50 to 6.00)
OG0024.333(4.00 to 4.42)
OG0032.167(1.95 to 5.75)
OG0046.033(6.00 to 6.07)
OG0056.050(4.08 to 6.07)
OG0065.933(NA to NA)This cannot be calculated due to insufficient data (only 1 participant had available data).
3.6
(0.4 to 12.3)
OG0043.4(0.7 to 9.5)
OG00510(0.3 to 44.5)
OG0060(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG00411
ParticipantsOG00510
ParticipantsOG0061
Title
Measurements
OG00050.0(1.3 to 98.7)
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG0020(NA to NA)Data could not be calculated due to the low number of events.
OG0030(NA to NA)Data could not be calculated due to the low number of events.
OG0040(NA to NA)Data could not be calculated due to the low number of events.
OG0050(NA to NA)Data could not be calculated due to the low number of events.
OG0060(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG004100
ParticipantsOG00520
ParticipantsOG0063
Title
Measurements
OG0006.3(0.2 to 30.2)
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG0024.2(0.1 to 21.1)
OG0032.9(0.3 to 9.9)
OG0043.0(0.6 to 8.5)
OG0055.0(0.1 to 24.9)
OG0060(NA to NA)Data could not be calculated due to the low number of events.
12.5
(5.2 to 24.1)
OG00411.2(5.5 to 19.7)
OG00510.0(0.3 to 44.5)
OG0060(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG00411
ParticipantsOG00510
ParticipantsOG0061
Title
Measurements
OG00050.0(1.3 to 98.7)
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG0020(NA to NA)Data could not be calculated due to the low number of events.
OG0030(NA to NA)Data could not be calculated due to the low number of events.
OG0040(NA to NA)Data could not be calculated due to the low number of events.
OG0050(NA to NA)Data could not be calculated due to the low number of events.
OG0060(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG004100
ParticipantsOG00520
ParticipantsOG0063
Title
Measurements
OG0006.3(0.2 to 30.2)
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG0028.3(1.0 to 27.0)
OG00310.0(4.1 to 19.5)
OG00410.0(4.9 to 17.6)
OG0055.0(0.1 to 54.9)
OG0060(NA to NA)Data could not be calculated due to the low number of events.
3.6
(0.4 to 12.3)
OG0049.0(4.0 to 16.9)
OG00510.0(0.3 to 44.5)
OG0060(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG00411
ParticipantsOG00510
ParticipantsOG0061
Title
Measurements
OG0000(NA to NA)Data could not be calculated due to the low number of events.
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG0020(NA to NA)Data could not be calculated due to the low number of events.
OG0030(NA to NA)Data could not be calculated due to the low number of events.
OG0040(NA to NA)Data could not be calculated due to the low number of events.
OG0050(NA to NA)Data could not be calculated due to the low number of events.
OG0060(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG004100
ParticipantsOG00520
ParticipantsOG0063
Title
Measurements
OG0000(NA to NA)Data could not be calculated due to the low number of events.
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG0020(NA to NA)Data could not be calculated due to the low number of events.
OG0032.9(0.3 to 9.9)
OG0048.0(3.5 to 15.2)
OG0055.0(0.1 to 24.9)
OG0060(NA to NA)Data could not be calculated due to the low number of events.
30.4
(18.8 to 44.1)
OG00420.2(12.4 to 30.1)
OG00510.0(0.3 to 44.5)
OG0060(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG00411
ParticipantsOG00510
ParticipantsOG0061
Title
Measurements
OG0000(NA to NA)Data could not be calculated due to the low number of events.
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG00216.7(2.1 to 48.4)
OG0037.1(0.2 to 33.9)
OG0049.1(0.2 to 41.3)
OG0050(NA to NA)Data could not be calculated due to the low number of events.
OG0060(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG004100
ParticipantsOG00520
ParticipantsOG0063
Title
Measurements
OG0006.3(0.2 to 30.2)
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG00220.8(7.1 to 42.2)
OG00325.7(16.0 to 37.6)
OG00419.0(11.8 to 28.1)
OG0055.0(0.1 to 24.9)
OG0060(NA to NA)Data could not be calculated due to the low number of events.
46.4
(33.0 to 60.3)
OG00440.4(30.2 to 51.4)
OG00530.0(6.7 to 65.2)
OG0060(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG00411
ParticipantsOG00510
ParticipantsOG0061
Title
Measurements
OG00050.0(1.3 to 98.7)
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG00216.7(2.1 to 48.4)
OG0037.1(0.2 to 33.9)
OG0049.1(0.2 to 41.3)
OG0050(NA to NA)Data could not be calculated due to the low number of events.
OG0060(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG004100
ParticipantsOG00520
ParticipantsOG0063
Title
Measurements
OG00012.5(1.6 to 38.3)
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG00229.2(12.6 to 51.1)
OG00338.6(27.2 to 51.0)
OG00437.0(27.6 to 47.2)
OG00515.0(3.2 to 37.9)
OG0060(NA to NA)Data could not be calculated due to the low number of events.
7.1
(2.0 to 17.3)
OG0047.9(3.2 to 15.5)
OG00530.0(6.7 to 65.2)
OG00650.0(1.3 to 98.7)
ParticipantsOG00411
ParticipantsOG00510
ParticipantsOG0061
Title
Measurements
OG0000(NA to NA)Data could not be calculated due to the low number of events.
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG0020(NA to NA)Data could not be calculated due to the low number of events.
OG0037.1(0.2 to 33.9)
OG0049.1(0.2 to 41.3)
OG0050(NA to NA)Data could not be calculated due to the low number of events.
OG0060(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG004100
ParticipantsOG00520
ParticipantsOG0063
Title
Measurements
OG0006.3(0.2 to 30.2)
OG00118.8(4.0 to 45.6)
OG00212.5(2.7 to 32.4)
OG0037.1(2.4 to 15.9)
OG0048.0(3.5 to 15.2)
OG00515.0(3.2 to 37.9)
OG00633.3(0.8 to 90.6)
53.6
(39.7 to 67.0)
OG00448.3(37.6 to 59.2)
OG00560.0(26.2 to 87.8)
OG00650.0(1.3 to 98.7)
ParticipantsOG00411
ParticipantsOG00510
ParticipantsOG0061
Title
Measurements
OG00050.0(1.3 to 98.7)
OG0010(NA to NA)Data could not be calculated due to the low number of events.
OG00216.7(2.1 to 48.4)
OG00314.3(1.8 to 42.8)
OG00418.2(2.3 to 51.8)
OG0050(NA to NA)Data could not be calculated due to the low number of events.
OG0060(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG004100
ParticipantsOG00520
ParticipantsOG0063
Title
Measurements
OG00018.8(4.0 to 45.6)
OG00118.8(4.0 to 45.6)
OG00241.7(22.1 to 63.4)
OG00345.7(33.7 to 58.1)
OG00445.0(35.0 to 55.3)
OG00530.0(11.9 to 54.3)
OG00633.3(0.8 to 90.6)
NA
(NA to NA)
Data could not be calculated due to the low number of events.
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000NA(NA to NA)Data could not be calculated due to the low number of events.
Participants
OG004
10
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG000NA(NA to NA)Data could not be calculated due to the low number of events.
OG002NA(NA to NA)Data could not be calculated due to the low number of events.
OG003NA(86.0 to NA)Data could not be calculated due to the low number of events.
OG004419.0(64.0 to NA)Data could not be calculated due to the low number of events.
OG005NA(NA to NA)Data could not be calculated due to the low number of events.
NA
(NA to NA)
Data could not be calculated due to the low number of events.
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Participants
OG004
12
ParticipantsOG0052
ParticipantsOG0060
Title
Measurements
OG002NA(NA to NA)Data could not be calculated due to the low number of events.
OG003NA(57.0 to NA)Data could not be calculated due to the low number of events.
OG004450.0(43.0 to NA)Data could not be calculated due to the low number of events.
OG005NA(NA to NA)Data could not be calculated due to the low number of events.
191.0
(57.0 to 420.0)
OG005NA(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00241.0(22.0 to 60.0)
OG00399.0(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG00431
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG000NA(NA to NA)Data could not be calculated due to the low number of events.
OG00279.0(22.0 to NA)Data could not be calculated due to the low number of events.
OG003120.0(58.0 to 383.0)
OG004191.0(57.0 to 420.0)
OG005NA(NA to NA)Data could not be calculated due to the low number of events.
191.0
(101.0 to 465.0)
OG005NA(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000NA(NA to NA)Data could not be calculated due to the low number of events.
OG00241.0(22.0 to 60.0)
OG00399.0(NA to NA)Data could not be calculated due to the low number of events.
OG004NA(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG00437
ParticipantsOG0053
ParticipantsOG0060
Title
Measurements
OG000NA(NA to NA)Data could not be calculated due to the low number of events.
OG00279.0(22.0 to NA)Data could not be calculated due to the low number of events.
OG00399.0(58.0 to 307.0)
OG004191.0(101.0 to 465.0)
OG005NA(NA to NA)Data could not be calculated due to the low number of events.
141.0
(58.0 to 383.0)
OG004220.0(111.0 to 482.0)
OG00559.0(15.0 to 59.0)
OG006NA(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000NA(NA to NA)Data could not be calculated due to the low number of events.
OG00241.0(22.0 to 60.0)
OG003109.5(99.0 to 120.0)
OG00485.0(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG00445
ParticipantsOG0056
ParticipantsOG0061
Title
Measurements
OG000NA(NA to NA)Data could not be calculated due to the low number of events.
OG001NA(NA to NA)Data could not be calculated due to the low number of events.
OG00279.0(9.0 to NA)Data could not be calculated due to the low number of events.
OG003126.0(58.0 to 307.0)
OG004220.0(85.0 to 482.0)
OG00559.0(15.0 to 59.0)
OG006NA(NA to NA)Data could not be calculated due to the low number of events.
56.0
(56 to 56)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00030.0(30 to 30)
Participants
OG004
10
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG00030.0(30 to 30)
OG002171.5(28 to 315)
OG003141.0(29 to 364)
OG00493.0(27 to 225)
OG00556.0(56 to 56)
29.0
(28 to 30)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Participants
OG004
12
ParticipantsOG0052
ParticipantsOG0060
Title
Measurements
OG002140.0(140 to 140)
OG003195.0(30 to 418)
OG00484.5(28 to 392)
OG00529.0(28 to 30)
39.5
(26 to 133)
OG00528.0(28 to 28)
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00271.5(71 to 72)
OG00330.0(30 to 30)
OG00430.0(30 to 30)
ParticipantsOG00431
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG00057.0(57 to 57)
OG00264.0(31 to 72)
OG00343.5(26 to 170)
OG00435.0(26 to 133)
OG00528.0(28 to 28)
31.5
(26 to 197)
OG00528.0(28 to 30)
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00030.0(30 to 30)
OG00271.5(71 to 72)
OG00330.0(30 to 30)
OG00430.0(30 to 30)
ParticipantsOG00437
ParticipantsOG0053
ParticipantsOG0060
Title
Measurements
OG00043.5(30 to 57)
OG00257.0(28 to 72)
OG00330.0(26 to 211)
OG00431.0(26 to 197)
OG00528.0(28 to 30)
29.0
(26 to 211)
OG00429.0(26 to 197)
OG00528.0(26 to 61)
OG00631.0(31 to 31)
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00030.0(30 to 30)
OG00271.5(71 to 72)
OG00329.5(29 to 30)
OG00429.5(29 to 30)
ParticipantsOG00445
ParticipantsOG0056
ParticipantsOG0061
Title
Measurements
OG00030.0(29 to 94)
OG00157.0(31 to 64)
OG00243.5(28 to 72)
OG00329.0(26 to 211)
OG00429.0(26 to 197)
OG00528.0(26 to 61)
OG00631.0(31 to 31)
43.5
(26 to 364)
OG00457.0(26 to 245)
OG00529.0(26 to 61)
OG00631.0(31 to 31)
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00030.0(30 to 30)
OG00271.5(71 to 72)
OG00329.5(29 to 30)
OG00429.5(29 to 30)
ParticipantsOG00445
ParticipantsOG0056
ParticipantsOG0061
Title
Measurements
OG00057.0(30 to 94)
OG00157.0(31 to 64)
OG00258.0(28 to 315)
OG00330.0(26 to 364)
OG00456.0(26 to 245)
OG00529.0(26 to 61)
OG00631.0(31 to 31)
246.0
(190.0 to 309.0)
OG004214.0(126.0 to 264.0)
OG005157.0(20.0 to 218.0)
OG006204.0(51.0 to 357.0)
ParticipantsOG00411
ParticipantsOG00510
ParticipantsOG0061
Title
Measurements
OG000NA(227.0 to NA)Data could not be calculated due to the low number of events.
OG00171.5(5.0 to 180.0)
OG002136.0(14.0 to 314.0)
OG003144.0(83.0 to 195.0)
OG00467.0(21.0 to 336.0)
OG00568.0(8.0 to 249.0)
OG00689.0(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG004100
ParticipantsOG00520
ParticipantsOG0063
Title
Measurements
OG000149.5(31.0 to 267.0)
OG00195.0(55.0 to 195.0)
OG002154.0(74.0 to 299.0)
OG003216.0(161.0 to 285.0)
OG004176.0(124.0 to 253.0)
OG005128.5(36.0 to 199.0)
OG00689.0(51.0 to 357.0)
112.0
(92.0 to 143.0)
OG004121.0(92.0 to 155.0)
OG00585.0(11.0 to 157.0)
OG00686.0(51.0 to 121.0)
ParticipantsOG00411
ParticipantsOG00510
ParticipantsOG0061
Title
Measurements
OG00058.0(NA to NA)Data could not be calculated due to the low number of events.
OG00139.0(5.0 to 67.0)
OG00274.0(12.0 to 131.0)
OG00385.5(37.0 to 126.0)
OG00445.0(21.0 to 113.0)
OG00543.0(8.0 to 83.0)
OG00671.0(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG004100
ParticipantsOG00520
ParticipantsOG0063
Title
Measurements
OG00058.0(19.0 to 88.0)
OG00155.5(38.0 to 92.0)
OG00276.0(61.0 to 119.0)
OG003108.0(90.0 to 126.0)
OG004118.0(88.0 to 140.0)
OG00565.0(20.0 to 100.0)
OG00671.0(51.0 to 121.0)
146.0
(47.0 to 247.0)
OG005296.0(130.0 to 462.0)
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000NA(NA to NA)Data could not be calculated due to the low number of events.
OG00241.0(22.0 to 60.0)
OG00399.0(NA to NA)Data could not be calculated due to the low number of events.
OG00438.0(NA to NA)Data could not be calculated due to the low number of events.
ParticipantsOG00437
ParticipantsOG0053
ParticipantsOG0060
Title
Measurements
OG000242.0(NA to NA)Data could not be calculated due to the low number of events.
OG00279.0(22.0 to 1126.0)
OG00398.0(58.0 to 187.0)
OG004146.0(45.0 to 247.0)
OG005296.0(130.0 to 462.0)
27.5
(14.6 to 43.9)
OG00440.4(27.6 to 54.2)
OG005NA(NA to NA)No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.
OG006NA(NA to NA)No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.
ParticipantsOG0046
ParticipantsOG0054
ParticipantsOG0061
Title
Measurements
OG000NA(NA to NA)No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.
OG001NA(NA to NA)No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.
OG00212.5(0.3 to 52.7)
OG00322.2(2.8 to 60.0)
OG00433.3(4.3 to 77.7)
OG005NA(NA to NA)No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.
OG006NA(NA to NA)No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.
ParticipantsOG00463
ParticipantsOG0058
ParticipantsOG0062
Title
Measurements
OG000NA(NA to NA)No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.
OG001NA(NA to NA)No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.
OG00225.0(7.3 to 52.4)
OG00326.5(14.9 to 41.1)
OG00439.7(27.6 to 52.8)
OG005NA(NA to NA)No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.
OG006NA(NA to NA)No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.