Trial Outcomes & Findings for A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission (NCT NCT02927262)

NCT ID: NCT02927262

Last Updated: 2024-11-26

Results Overview

RFS was defined as the time from the date of randomization until the date of documented relapse or death from any cause, whichever occurred first. Relapse after complete remission (CR) \[including complete remission with incomplete platelet recovery (CRp) and Complete remission with incomplete hematologic recovery (CRi)\], was defined as bone marrow blasts 5% or higher (not attributable to regenerating bone marrow), any circulating blasts, any extra-medullary blast foci as per Revised International Working Group (IWG) criteria. Participants were classified as: CRi, if they fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia \< 1 × 10\^9/L with or without complete platelet recovery. RBC and platelet transfusion independence was not required. CRp, if they achieved CR except for incomplete platelet recovery (\< 100 × 10\^9/L). RFS was estimated using Kaplan-Meier estimates. hazard ratio (HR), cox proportional hazards model (CHM)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 98 participants
• Primary outcome timeframe: From the date of randomization until the date of documented relapse, or death; (Median time on study drug was 427 days for gilteritinib group and 212 days for placebo group)
• Results posted on: 2024-11-26

Participant Flow

Adult participants diagnosed with FMS-like tyrosine kinase 3 (FLT3)/internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1), including complete remission with incomplete platelet recovery (CRp) and complete remission with incomplete hematologic recovery (CRi) for whom a decision not to proceed with transplantation was made, or a suitable donor could not be identified, were enrolled in this study.

Randomization was stratified based on: Age (<60 or ≥60 years), Geographic region (North America or Europe or rest of the world), Presence of Minimal Residual Disease (MRD) at screening (yes or no), Use of FLT3-inhibiting agents during induction/consolidation (yes or no).

Participant milestones

Measure	Gilteritinib Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.	Placebo Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Treatment Period (Up to 744 Days) STARTED	63	35
Treatment Period (Up to 744 Days) COMPLETED	24	12
Treatment Period (Up to 744 Days) NOT COMPLETED	39	23
Long Term Follow-up (Up to 1201 Days) STARTED	60	35
Long Term Follow-up (Up to 1201 Days) Did Not Enter Long Term Follow up Period	3	0
Long Term Follow-up (Up to 1201 Days) COMPLETED	35	21
Long Term Follow-up (Up to 1201 Days) NOT COMPLETED	25	14

Reasons for withdrawal

Measure	Gilteritinib Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.	Placebo Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Treatment Period (Up to 744 Days) Withdrawal by Subject	3	0
Treatment Period (Up to 744 Days) Death	1	0
Treatment Period (Up to 744 Days) Treatment ended due to transplant procedure	1	0
Treatment Period (Up to 744 Days) Physician Decision	1	0
Treatment Period (Up to 744 Days) Becomes eligible for and proceeds to transplant	0	1
Treatment Period (Up to 744 Days) Participant relapsed and became eligible for and proceeded to transplant	0	1
Treatment Period (Up to 744 Days) Randomized in error	1	0
Treatment Period (Up to 744 Days) Participant was not eligible for the study	1	0
Treatment Period (Up to 744 Days) MRD positive	0	1
Treatment Period (Up to 744 Days) Disease Relapse	23	18
Treatment Period (Up to 744 Days) Adverse Event	7	1
Treatment Period (Up to 744 Days) Investigators decision to take participant off trial due to molecular relapse	1	0
Treatment Period (Up to 744 Days) Clinicians decision as suspected relapse	0	1
Long Term Follow-up (Up to 1201 Days) Withdrawal by Subject	0	2
Long Term Follow-up (Up to 1201 Days) Lost to Follow-up	2	0
Long Term Follow-up (Up to 1201 Days) Death	23	12

Baseline Characteristics

A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission

Baseline characteristics by cohort

Measure	Gilteritinib n=63 Participants Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.	Placebo n=35 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.	Total n=98 Participants Total of all reporting groups
Age, Continuous	61.4 Years STANDARD_DEVIATION 11.0 • n=5 Participants	59.9 Years STANDARD_DEVIATION 13.9 • n=7 Participants	60.9 Years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	20 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	15 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	29 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	22 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Age (<60 or ≥60 years) <60 years	24 Participants n=5 Participants	13 Participants n=7 Participants	37 Participants n=5 Participants
Age (<60 or ≥60 years) ≥60 years	39 Participants n=5 Participants	22 Participants n=7 Participants	61 Participants n=5 Participants
Geographic Region North America	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Geographic Region Europe	40 Participants n=5 Participants	20 Participants n=7 Participants	60 Participants n=5 Participants
Geographic Region Rest of the world	18 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants
Presence of MRD MRD = Yes	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Presence of MRD MRD = No	55 Participants n=5 Participants	29 Participants n=7 Participants	84 Participants n=5 Participants
Use of FLT3-inhibitors Use of FLT3 Inhibitor = Yes	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Use of FLT3-inhibitors Use of FLT3 Inhibitor = No	51 Participants n=5 Participants	25 Participants n=7 Participants	76 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of randomization until the date of documented relapse, or death; (Median time on study drug was 427 days for gilteritinib group and 212 days for placebo group)

Population: The full analysis set (FAS) consisted of all participants who were randomized.

RFS was defined as the time from the date of randomization until the date of documented relapse or death from any cause, whichever occurred first. Relapse after complete remission (CR) [including complete remission with incomplete platelet recovery (CRp) and Complete remission with incomplete hematologic recovery (CRi)], was defined as bone marrow blasts 5% or higher (not attributable to regenerating bone marrow), any circulating blasts, any extra-medullary blast foci as per Revised International Working Group (IWG) criteria.

Participants were classified as:

CRi, if they fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia < 1 × 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence was not required.

CRp, if they achieved CR except for incomplete platelet recovery (< 100 × 10^9/L).

RFS was estimated using Kaplan-Meier estimates. hazard ratio (HR), cox proportional hazards model (CHM)

Outcome measures

Measure	Gilteritinib n=63 Participants Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.	Placebo n=35 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Relapse-free Survival (RFS) Per Independent Review Committee (IRC) Adjudication	24.02 Months Interval 14.06 to Upper limit was not estimable due to low number of events	15.84 Months Interval 3.02 to Upper limit was not estimable due to low number of events

SECONDARY outcome

Timeframe: From the date of randomization until the date of death from any cause; (Median time on study drug was 427 days for gilteritinib group and 212 days for placebo group)

Population: FAS Population

OS was defined as the time from the date of randomization until the date of death from any cause. OS was estimated using Kaplan-Meiers method.

Outcome measures

Measure	Gilteritinib n=63 Participants Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.	Placebo n=35 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Overall Survival (OS)	NA Months Interval 30.42 to Median and upper limit were not estimable due to low number of events	NA Months Interval 43.56 to Median and upper limit were not estimable due to low number of events

SECONDARY outcome

Timeframe: From date of randomization until the date of documented relapse or discontinuation of the treatment, or initiation of other anti-leukemic treatment or death from any cause; (Median time on study drug was 427 days for gilteritinib and 212 days for Placebo)

Population: FAS Population

EFS was defined as the time from the date of randomization until the date of documented relapse or discontinuation of the treatment, or initiation of other anti-leukemic treatment or death from any cause, whichever occurred first. Relapse after CR (including CRp and CRi), was defined as bone marrow blasts 5% or higher (not attributable to regenerating bone marrow), any circulating blasts, any extra-medullary blast foci as per Revised IWG criteria.

Participants were classified as:

CRi, if they fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia < 1 × 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence was not required.

CRp, if they achieved CR except for incomplete platelet recovery (< 100 × 10^9/L).

EFS was estimated using Kaplan-Meier's method.

Outcome measures

Measure	Gilteritinib n=63 Participants Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.	Placebo n=35 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Event-Free Survival (EFS)	14.06 Months Interval 9.89 to 23.72	6.74 Months Interval 2.86 to 21.95

SECONDARY outcome

Timeframe: Baseline and months 3, 6, 12, 24/EoT

Population: FAS population with available data at specified time point.

MRD was measured from bone marrow samples. FLT3/ITD mutation ratio was measured in relation to total FLT3. For a participant with multiple ITD mutations, the overall FLT3/ITD mutation ratio was calculated from the sum of all ITD mutations. Absence of Minimal Residual Disease (MRD) is defined as log10-transformed overall FLT3/ITD mutation ratio ≤ -4.

Outcome measures

Measure	Gilteritinib n=48 Participants Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.	Placebo n=22 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Change From Baseline in Quantitative Minimal Residual Disease Measured as Log10-transformed Overall FLT3/ITD Mutation Ratio at Months 3, 6, 12, 24/End of Treatment (EoT) Month 3	0.14 Ratio Standard Deviation 0.96	0.14 Ratio Standard Deviation 1.46
Change From Baseline in Quantitative Minimal Residual Disease Measured as Log10-transformed Overall FLT3/ITD Mutation Ratio at Months 3, 6, 12, 24/End of Treatment (EoT) Month 6	0.07 Ratio Standard Deviation 0.92	-0.17 Ratio Standard Deviation 0.79
Change From Baseline in Quantitative Minimal Residual Disease Measured as Log10-transformed Overall FLT3/ITD Mutation Ratio at Months 3, 6, 12, 24/End of Treatment (EoT) Month 12	-0.11 Ratio Standard Deviation 0.60	-0.34 Ratio Standard Deviation 0.67
Change From Baseline in Quantitative Minimal Residual Disease Measured as Log10-transformed Overall FLT3/ITD Mutation Ratio at Months 3, 6, 12, 24/End of Treatment (EoT) Month 24/EoT	-0.12 Ratio Standard Deviation 1.08	0.23 Ratio Standard Deviation 1.63

SECONDARY outcome

Timeframe: From first dose date up to 30 days after last dose or data cut-off date 25-May 2021 (Maximum treatment duration was 744 days)

Population: The safety analysis set (SAF) consisted of all randomized participants who received at least one dose of study drug.

An AE is any untoward medical occurrence in a participant administered a study drug, which does not necessarily have to have a causal relationship with treatment. It can, be any unfavorable and unintended sign, symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product whether considered related to the medicinal product. An AE is considered "serious" if, it results in results in death, is life-threatening (an AE is considered "life-threatening" if, its occurrence places the participant at immediate risk of death, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, Requires inpatient hospitalization (except for planned procedures as allowed per study) or leads to prolongation of hospitalization.

TEAE was defined as an AE observed after starting administration of the study drug through 30 days after the last dose.

Outcome measures

Measure	Gilteritinib n=62 Participants Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.	Placebo n=35 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Number of Participants With Adverse Events (AE) TEAE	58 Participants	33 Participants
Number of Participants With Adverse Events (AE) Drug-Related TEAE	51 Participants	20 Participants
Number of Participants With Adverse Events (AE) TEAE before Relapse	57 Participants	28 Participants
Number of Participants With Adverse Events (AE) Drug-Related TEAE before Relapse	51 Participants	15 Participants
Number of Participants With Adverse Events (AE) Serious TEAE	24 Participants	14 Participants
Number of Participants With Adverse Events (AE) Drug-Related Serious TEAE	10 Participants	3 Participants
Number of Participants With Adverse Events (AE) TEAE Leading to Death	1 Participants	1 Participants
Number of Participants With Adverse Events (AE) Drug-Related TEAE Leading to Death	0 Participants	1 Participants
Number of Participants With Adverse Events (AE) TEAE Leading to Withdrawal of Treatment	15 Participants	6 Participants
Number of Participants With Adverse Events (AE) Drug-Related TEAE Leading to Withdrawal of Treatment	5 Participants	2 Participants
Number of Participants With Adverse Events (AE) TEAE Leading to Dose Reduction	15 Participants	1 Participants
Number of Participants With Adverse Events (AE) Drug-Related TEAE Leading to Dose Reduction	14 Participants	1 Participants
Number of Participants With Adverse Events (AE) TEAE Leading to Dose Interruption	35 Participants	4 Participants
Number of Participants With Adverse Events (AE) Drug-Related TEAE Leading to Dose Interruption	31 Participants	1 Participants
Number of Participants With Adverse Events (AE) Grade 3 or Higher Treatment-Emergent Adverse Events	42 Participants	18 Participants
Number of Participants With Adverse Events (AE) Grade 3 or Higher Drug-related TEAE	33 Participants	4 Participants
Number of Participants With Adverse Events (AE) Death	20 Participants	11 Participants

SECONDARY outcome

Timeframe: Months 1, 2, 3, 4, 5, 6, 8, 10. 12, 14, 16, 18, 20, 22 and 24/EoT

Population: Safety population with available data at specified time point.

ECOG performance status was measured on an 6 point scale. 0-Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5. Dead.

Number of participants with ECOG PS was reported. ECOG PS grades with zero participants were not reported.

Outcome measures

Measure	Gilteritinib n=62 Participants Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.	Placebo n=35 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 24/EoT: Grade 4	1 Participants	1 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 22: Grade 0	20 Participants	11 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 22: Grade 1	4 Participants	2 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 24/EoT: Grade 0	34 Participants	20 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 24/EoT: Grade 1	14 Participants	6 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 24/EoT: Grade 2	1 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 24/EoT: Grade 3	1 Participants	1 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Baseline: Grade 0	39 Participants	22 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Baseline: Grade 1	23 Participants	13 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 2: Grade 0	38 Participants	18 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 2: Grade 1	16 Participants	9 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 2: Grade 2	0 Participants	1 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 3: Grade 0	33 Participants	20 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 3: Grade 1	19 Participants	4 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 3: Grade 2	0 Participants	1 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 4: Grade 0	37 Participants	16 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 4: Grade 1	12 Participants	6 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 5: Grade 0	35 Participants	17 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 5: Grade 1	11 Participants	4 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 6: Grade 0	32 Participants	17 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 6: Grade 1	11 Participants	2 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 8: Grade 0	32 Participants	12 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 8: Grade 1	8 Participants	6 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 8: Grade 2	1 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 10: Grade 0	29 Participants	14 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 10: Grade 1	8 Participants	3 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 12: Grade 0	24 Participants	14 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 12: Grade 1	11 Participants	3 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 14: Grade 0	21 Participants	13 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 14: Grade 1	9 Participants	3 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 16: Grade 0	22 Participants	11 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 16: Grade 1	4 Participants	2 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 16: Grade 2	2 Participants	0 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 18: Grade 0	19 Participants	13 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 18: Grade 1	8 Participants	1 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 20: Grade 0	18 Participants	13 Participants
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Month 20: Grade 1	7 Participants	1 Participants

Adverse Events

Gilteritinib

Serious events: 24 serious events

Other events: 53 other events

Deaths: 24 deaths

Placebo

Serious events: 14 serious events

Other events: 32 other events

Deaths: 12 deaths

Serious adverse events

Measure	Gilteritinib n=62 participants at risk Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.	Placebo n=35 participants at risk Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Blood and lymphatic system disorders Anaemia	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Blood and lymphatic system disorders Bone marrow failure	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Blood and lymphatic system disorders Febrile neutropenia	3.2% 2/62 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Blood and lymphatic system disorders Hyperleukocytosis	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Blood and lymphatic system disorders Neutropenia	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Blood and lymphatic system disorders Thrombocytopenia	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Cardiac disorders Atrial fibrillation	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Cardiac disorders Cardiac failure acute	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Gastrointestinal disorders Nausea	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Gastrointestinal disorders Vomiting	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
General disorders Pyrexia	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Hepatobiliary disorders Hepatitis	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Infections and infestations Device related infection	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Infections and infestations Influenza	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Infections and infestations Lower respiratory tract infection	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Infections and infestations Pneumonia	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Infections and infestations Sepsis	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Infections and infestations Upper respiratory tract infection	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Investigations Alanine aminotransferase increased	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Investigations Aspartate aminotransferase increased	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Investigations Neutrophil count decreased	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Investigations Platelet count decreased	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Metabolism and nutrition disorders Hyperglycaemia	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Musculoskeletal and connective tissue disorders Tenosynovitis	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	11.3% 7/62 • Number of events 7 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	14.3% 5/35 • Number of events 5 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chloroma	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial tumour haemorrhage	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia recurrent	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Systemic mastocytosis	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Nervous system disorders Cerebral haemorrhage	1.6% 1/62 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Nervous system disorders Epilepsy	1.6% 1/62 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Renal and urinary disorders Ureterolithiasis	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	1.6% 1/62 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Cough	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Skin and subcutaneous tissue disorders Skin ulcer	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Vascular disorders Neurogenic shock	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.

Other adverse events

Measure	Gilteritinib n=62 participants at risk Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.	Placebo n=35 participants at risk Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Blood and lymphatic system disorders Anaemia	8.1% 5/62 • Number of events 8 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	14.3% 5/35 • Number of events 8 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Blood and lymphatic system disorders Leukopenia	11.3% 7/62 • Number of events 8 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Blood and lymphatic system disorders Neutropenia	16.1% 10/62 • Number of events 32 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Blood and lymphatic system disorders Thrombocytopenia	17.7% 11/62 • Number of events 17 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	11.4% 4/35 • Number of events 4 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Ear and labyrinth disorders Vertigo	8.1% 5/62 • Number of events 5 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Eye disorders Dry eye	8.1% 5/62 • Number of events 6 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Gastrointestinal disorders Constipation	11.3% 7/62 • Number of events 8 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Gastrointestinal disorders Diarrhoea	8.1% 5/62 • Number of events 8 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	8.6% 3/35 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.5% 4/62 • Number of events 4 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Gastrointestinal disorders Nausea	12.9% 8/62 • Number of events 10 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	20.0% 7/35 • Number of events 7 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Gastrointestinal disorders Stomatitis	4.8% 3/62 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	8.6% 3/35 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Gastrointestinal disorders Vomiting	3.2% 2/62 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
General disorders Fatigue	16.1% 10/62 • Number of events 10 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	8.6% 3/35 • Number of events 4 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
General disorders Malaise	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	8.6% 3/35 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
General disorders Oedema peripheral	4.8% 3/62 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	11.4% 4/35 • Number of events 4 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
General disorders Pyrexia	4.8% 3/62 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	8.6% 3/35 • Number of events 4 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Hepatobiliary disorders Hepatic function abnormal	6.5% 4/62 • Number of events 5 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Infections and infestations Bronchitis	6.5% 4/62 • Number of events 4 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Infections and infestations Herpes zoster	1.6% 1/62 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Infections and infestations Influenza	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Infections and infestations Nasopharyngitis	11.3% 7/62 • Number of events 11 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	17.1% 6/35 • Number of events 11 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Infections and infestations Otitis media	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Infections and infestations Upper respiratory tract infection	4.8% 3/62 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Infections and infestations Urinary tract infection	4.8% 3/62 • Number of events 7 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Injury, poisoning and procedural complications Contusion	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	8.6% 3/35 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Investigations Alanine aminotransferase increased	12.9% 8/62 • Number of events 17 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Investigations Aspartate aminotransferase increased	11.3% 7/62 • Number of events 12 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Investigations Blood bilirubin increased	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 6 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Investigations Blood creatine phosphokinase increased	29.0% 18/62 • Number of events 37 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Investigations Blood creatinine increased	8.1% 5/62 • Number of events 5 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Investigations Blood lactate dehydrogenase increased	11.3% 7/62 • Number of events 7 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	0.00% 0/35 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Investigations Neutrophil count decreased	19.4% 12/62 • Number of events 46 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	8.6% 3/35 • Number of events 5 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Investigations Platelet count decreased	19.4% 12/62 • Number of events 24 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	11.4% 4/35 • Number of events 10 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Investigations Weight increased	12.9% 8/62 • Number of events 11 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 4 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Investigations White blood cell count decreased	9.7% 6/62 • Number of events 24 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	8.6% 3/35 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	8.6% 3/35 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Metabolism and nutrition disorders Hypertriglyceridaemia	3.2% 2/62 • Number of events 7 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 5 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Metabolism and nutrition disorders Hyperuricaemia	6.5% 4/62 • Number of events 7 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 4/62 • Number of events 6 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	8.6% 3/35 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Musculoskeletal and connective tissue disorders Back pain	3.2% 2/62 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	11.4% 4/35 • Number of events 4 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Musculoskeletal and connective tissue disorders Pain in extremity	6.5% 4/62 • Number of events 4 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Nervous system disorders Dizziness	12.9% 8/62 • Number of events 9 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	11.4% 4/35 • Number of events 4 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Nervous system disorders Headache	8.1% 5/62 • Number of events 9 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Psychiatric disorders Insomnia	6.5% 4/62 • Number of events 5 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Psychiatric disorders Restlessness	1.6% 1/62 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Reproductive system and breast disorders Erectile dysfunction	3.2% 2/62 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Cough	14.5% 9/62 • Number of events 12 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.5% 4/62 • Number of events 5 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.5% 4/62 • Number of events 5 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.6% 1/62 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Skin and subcutaneous tissue disorders Pruritus	9.7% 6/62 • Number of events 6 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Skin and subcutaneous tissue disorders Rash	4.8% 3/62 • Number of events 3 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	8.6% 3/35 • Number of events 4 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/62 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	5.7% 2/35 • Number of events 2 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.
Vascular disorders Hypertension	6.5% 4/62 • Number of events 4 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.	2.9% 1/35 • Number of events 1 • From the date of randomization up to end of study (85 months and 9 days) All randomized participants for All-cause mortality. Safety Population (SAF) for serious adverse events and non-serious adverse events. The SAF consisted of all randomized participants who took at least 1 dose of study intervention and was used for safety analyses.

Additional Information

Clinical trial Disclosure

Astellas Pharma Global Development, Inc

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Email: astellas.resultsdisclosure@astellas.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
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Restriction type: OTHER