Trial Outcomes & Findings for A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML) (NCT NCT02997202)

NCT ID: NCT02997202

Last Updated: 2025-01-17

Results Overview

RFS was defined as the time from the date of randomization until the date of documented morphological relapse, or death from any cause, whichever occurred first. Morphological relapse was defined as documentation of any of the following events: * BM blasts ≥ 5% (not attributable to regenerating BM) * Any circulating blasts (not attributable to regenerating BM or growth factors) * Presence of extramedullary blast foci per Revised International Working Group (RIWG) criteria * The earliest date of any of the relapse event was used for RFS.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 356 participants
• Primary outcome timeframe: From the date of randomization up to 64 months and 22 days
• Results posted on: 2025-01-17

Participant Flow

Participants with FMS-like tyrosine kinase 3/Internal tandem duplication (FLT3/ITD) acute myeloid leukemia (AML) in first morphological complete remission (CR1) including complete remission with incomplete platelet recovery (CRp) & complete remission with incomplete hematologic recovery (CRi) undergoing allogeneic hematopoietic cell transplant (HCT) were enrolled in the study.

Randomization was stratified by: Conditioning regimen intensity myeloablative vs reduced intensity/non-myeloablative (RIC/NMA); Time from first day of hematopoietic cell infusion to randomization (30 to 60 vs 61 to 90 days); Presence vs absence of/unknown, Minimal Residual Disease-4 (MRD-4) from the most recent pre-registration Bone marrow (BM).

Participant milestones

Measure	Gilteritinib Participants received gilteritinib 120 milligrams (mg) (three tablets of 40 mg) orally, once daily (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.
Overall Study STARTED	178	178
Overall Study Safety Analysis Population	178	177
Overall Study Intent to Treat (ITT) Population	178	178
Overall Study COMPLETED	122	116
Overall Study NOT COMPLETED	56	62

Reasons for withdrawal

Measure	Gilteritinib Participants received gilteritinib 120 milligrams (mg) (three tablets of 40 mg) orally, once daily (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.
Overall Study Miscellaneous	2	2
Overall Study Withdrawal by Subject	8	12
Overall Study Lost to Follow-up	5	3
Overall Study Death	41	45

Baseline Characteristics

A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)

Baseline characteristics by cohort

Measure	Gilteritinib n=178 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=178 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.	Total n=356 Participants Total of all reporting groups
Age, Continuous	50.3 Years STANDARD_DEVIATION 13.6 • n=5 Participants	51.8 Years STANDARD_DEVIATION 12.3 • n=7 Participants	51 Years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants	86 Participants n=7 Participants	173 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	92 Participants n=7 Participants	183 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	162 Participants n=5 Participants	162 Participants n=7 Participants	324 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	7 Participants n=7 Participants	20 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	47 Participants n=5 Participants	56 Participants n=7 Participants	103 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	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	114 Participants n=5 Participants	106 Participants n=7 Participants	220 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	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Number of participants with conditioning regimen intensity MAC	103 Participants n=5 Participants	103 Participants n=7 Participants	206 Participants n=5 Participants
Number of participants with conditioning regimen intensity RIC/NMA	75 Participants n=5 Participants	75 Participants n=7 Participants	150 Participants n=5 Participants
Number of Participants With Time from first day of hematopoietic cell infusion to randomization 30-60 days	95 Participants n=5 Participants	97 Participants n=7 Participants	192 Participants n=5 Participants
Number of Participants With Time from first day of hematopoietic cell infusion to randomization 61-90 days	83 Participants n=5 Participants	81 Participants n=7 Participants	164 Participants n=5 Participants
Presence of MRD Present	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Presence of MRD Absent/Unknown	144 Participants n=5 Participants	145 Participants n=7 Participants	289 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of randomization up to 64 months and 22 days

Population: ITT population

RFS was defined as the time from the date of randomization until the date of documented morphological relapse, or death from any cause, whichever occurred first. Morphological relapse was defined as documentation of any of the following events:

• BM blasts ≥ 5% (not attributable to regenerating BM)
• Any circulating blasts (not attributable to regenerating BM or growth factors)
• Presence of extramedullary blast foci per Revised International Working Group (RIWG) criteria
• The earliest date of any of the relapse event was used for RFS.

Outcome measures

Measure	Gilteritinib n=178 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=178 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)	NA months Data was not estimable because less than 50% of participants had event (data was estimated using Kaplan-Meier \[KM\] and it requires at least 50% of event to be able to calculate time using KM).	NA months Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM).

SECONDARY outcome

Timeframe: From the date of randomization up to 64 months and 22 day

Population: ITT population

OS was defined as the time from randomization until the date of death from any cause (death date - first dose date + 1). For a Participant who were not known to have died by the end of study follow-up, OS was censored at the date of last contact (date of last contact - first dose date + 1).

Outcome measures

Measure	Gilteritinib n=178 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=178 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 Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM).	NA months Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM).

SECONDARY outcome

Timeframe: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days

Population: Safety Analysis Population: consisted of all participants who took at least 1 dose of study drug (gilteritinib or placebo).

An Adverse event (AE) was any untoward medical occurrence in a participant administered a study drug, and which did not have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether considered related to the medicinal product.

TEAE defined as an AE event observed through 30 days after the last dose.

Outcome measures

Measure	Gilteritinib n=178 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=177 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 Treatment Emergent Adverse Events (TEAE)	175 participants	162 participants

SECONDARY outcome

Timeframe: Baseline, month 24

Population: Safety Analysis Population with available data was analyzed.

KPS scores of participants were reported. KPS was a standard way of measuring ability of cancer participants to perform ordinary tasks. It was 11 level score which ranged between 0-100%. 100 =Normal, no complaints, no evidence of disease 90 =Able to carry on normal activity, minor signs or symptoms of disease 80 =Normal activity with effort, some signs or symptoms of disease 70 =Care for self, unable to carry on normal activity or to do work 60 =Required occasional assistance but was able to care for most of his needs 50 =Required considerable assistance & frequent medical care 40 =Disabled, required special care & assistance 30 = Severely disabled, hospitalization indicated, although death not imminent 20 =Very sick, hospitalization necessary, active supportive treatment necessary 10 =moribund fatal processes progressing rapidly 0 =Dead.

Outcome measures

Measure	Gilteritinib n=174 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=169 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Karnofsky Performance Status Scores Baseline	84.20 unit on a scale Standard Deviation 10.65	84.73 unit on a scale Standard Deviation 10.69
Karnofsky Performance Status Scores Month 24	93.12 unit on a scale Standard Deviation 8.34	91.67 unit on a scale Standard Deviation 9.48

SECONDARY outcome

Timeframe: From the date of randomization up to 64 months and 22 days

Population: ITT population

NRM was defined as death from any cause other than relapse or disease progression (DP). Relapse was defined as documentation of any of the following events:

• BM blasts ≥ 5% (not attributable to regenerating BM)
• Any circulating blasts (not attributable to regenerating BM or growth factors)
• Presence of extramedullary blast foci per RIWG criteria
• The earliest date of any of the relapse event were used for RFS. DP: >=20% increase in sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non-target lesions. Appearance of at least 1 new lesion. Incidence of NRM was estimated using the cumulative incidence function, treating relapse/progression as a competing risk.

Outcome measures

Measure	Gilteritinib n=178 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=178 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Percentage of Participants With Non-relapse Mortality (NRM)	13.6 percentage of participants Interval 8.9 to 19.2	6.6 percentage of participants Interval 3.5 to 11.0

SECONDARY outcome

Timeframe: From the date of randomization up to 64 months and 22 days

Population: ITT population

EFS: Time from date of randomization until documented relapse, or premature discontinuation of treatment or initiation of other anti-leukemic treatment or death from any cause, whichever occurred first.

Relapse was defined as documentation of any of following events:

• BM blasts ≥ 5% (not attributable to regenerating BM)
• Any circulating blasts (not attributable to regenerating BM or growth factors)
• Presence of extramedullary blast foci per RIWG criteria
• The earliest date of any of relapse event were used for RFS.

Anti-leukemic treatment was defined as hypomethylating agents, chemotherapy, oral anticancer agents, Donor lymphocyte infusion (DLI) or cellular therapies given because of detectable disease, not meeting R-IWG criteria for relapse.

Outcome measures

Measure	Gilteritinib n=178 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=178 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)	NA months Interval 19.65 to Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM).	NA months Interval 15.05 to Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM).

SECONDARY outcome

Timeframe: From the date of randomization up to 6 months

Population: ITT population

The cumulative incidence at 6 months after randomization of grades II-IV and grades III-IV aGVHD were reported, treating death prior to aGVHD as the competing risk. It was graded according to diagnosis and severity scoring used by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The acute GVHD algorithm calculated the grade based on the organ (skin, gastrointestinal (GI)and liver) stage and etiology/biopsy reported on the weekly GVHD form. Grade I aGVHD was defined as Skin stage of 1-2 and stage 0 for both GI and liver organs. Grade II aGVHD was stage 3 of skin, or stage 1 of GI, or stage 1 of liver. Grade III is stage 2-4 for GI, or stage 2-3 of liver. Grade IV was stage 4 of skin, or stage 4 of liver. Grade IV was the worst outcome. Treatment emergent was defined as an event observed through 30 days after the last dose.

Outcome measures

Measure	Gilteritinib n=178 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=178 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Percentage of Participants With Treatment Emergent Acute Graft vs. Host Disease (aGVHD) aGVHD II to IV	16.5 percentage of participants Interval 11.3 to 22.5	19.2 percentage of participants Interval 13.6 to 25.6
Percentage of Participants With Treatment Emergent Acute Graft vs. Host Disease (aGVHD) aGVHD III to IV	5.9 percentage of participants Interval 3.0 to 10.1	4.1 percentage of participants Interval 1.8 to 7.9

SECONDARY outcome

Timeframe: From the date of randomization up to 12 months

Population: ITT population

Chronic GVHD was graded according to diagnosis and severity scoring from the National Institute of Health (NIH) 2014 Consensus Criteria. Eight organs - skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia were scored on a 0-3 scale to reflect degree of chronic GVHD involvement, where 0 = no involvement/no symptoms & 3 indicated the worst symptom. This system staged severity in each individual organ, and then a global score defined as mild, moderate or severe, based on number of organs involved and organ severity score was calculated. The cumulative incidence of chronic GVHD (mild, moderate, severe) at 12 months after randomization was reported, treating death prior to chronic GVHD as the competing risk. Treatment emergent was defined as an event observed through 30 days after the last dose.

Outcome measures

Measure	Gilteritinib n=178 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=178 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Percentage of Participants With Treatment Emergent Chronic GVHD at 12 Months	57.0 percentage of participants Interval 48.5 to 64.6	48.1 percentage of participants Interval 39.5 to 56.2

SECONDARY outcome

Timeframe: From the date of randomization up to 24 months

Population: ITT population

Chronic GVHD was graded according to diagnosis and severity scoring from the NIH 2014 Consensus Criteria. Eight organs- skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are scored on a 0-3 scale to reflect degree of chronic GVHD involvement where 0 = no involvement/no symptoms & 3 indicated the worst symptom. This system staged severity in each individual organ, and then a global score defined as mild, moderate or severe, based on number of organs involved and organ severity score was calculated. The cumulative incidence of chronic GVHD (mild, moderate, severe) at 24 months after randomization was reported, treating death prior to chronic GVHD as the competing risk. Treatment emergent was defined as an event observed through 30 days after the last dose.

Outcome measures

Measure	Gilteritinib n=178 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=178 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Percentage of Participants With Treatment Emergent Chronic GVHD at 24 Months	61.9 percentage of participants Interval 53.3 to 69.4	51.8 percentage of participants Interval 42.9 to 59.9

SECONDARY outcome

Timeframe: From the date of randomization up to 64 months and 22 days

Population: ITT population with available data was analyzed.

The presence of MRD was considered Detectable in participants who were FLT3/ITD MRD undetectable prior to randomization if log10-transformed overall FLT3/ITD mutation ratio greater than -4 otherwise presence of MRD was considered Not Detectable. Participants who had detectable FLT3/ITD MRD prior to randomization were considered eradicated if log10-transformed overall FLT3/ITD mutation ratio ≤ -4. Incidence of MRD Eradication and Detection were estimated using the cumulative incidence function, treating death during MRD assessment period without documentation of MRD event as competing risk.

Outcome measures

Measure	Gilteritinib n=165 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=162 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Percentage of Participants With FMS-like Tyrosine Kinase 3/Internal Tandem Duplication (FLT3/ITD) Minimal Residual Disease (MRD) MRD Eradication	80 percentage of participants Interval 4.7 to 98.4	NA percentage of participants Data was not estimable because no participants in Placebo group were followed up to 1 year (cumulative incidence function requires at least 1 participant to calculate the cumulative incidence rate).
Percentage of Participants With FMS-like Tyrosine Kinase 3/Internal Tandem Duplication (FLT3/ITD) Minimal Residual Disease (MRD) MRD 10^-4 Detection	7.1 percentage of participants Interval 3.4 to 12.4	9.2 percentage of participants Interval 5.0 to 15.0

SECONDARY outcome

Timeframe: From the date of randomization up to 64 months and 22 days

Population: ITT population

Cumulative incidence of relapse was reported, treating death in remission as a competing risk. Relapse was defined as documentation of any of the following events:

• BM blasts ≥ 5% (not attributable to regenerating BM)
• Any circulating blasts (not attributable to regenerating BM or growth factors)
• Presence of extramedullary blast foci per RIWG criteria
• The earliest date of any of the relapse event were used for RFS.

Outcome measures

Measure	Gilteritinib n=178 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=178 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Percentage of Participants With Relapse	12.4 percentage of participants Interval 7.9 to 17.8	26.7 percentage of participants Interval 20.3 to 33.5

SECONDARY outcome

Timeframe: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days

Population: ITT population

Severity of Infection was assessed based on the following criteria:

Grade 1-Mild Asymptomatic or mild symptoms, clinical or diagnostic observations noted intervention not indicated.

Grade 2-Moderate Local or noninvasive intervention indicated. Grade 3-Severe Medically significant but not immediately life threatening, hospitalization or prolonged hospitalization. Grade 4-Life Threatening Life threatening consequences, urgent intervention indicated.

Grade 5-Death related to the AE. Cumulative incidence of grade 3 to 5 infections were reported, treating death (grade 5) as a competing event. Treatment emergent was defined as an event observed through 30 days after the last dose.

Outcome measures

Measure	Gilteritinib n=178 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=178 Participants Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
Percentage of Participants With Treatment Emergent Infection by Severity.	39.6 percentage of participants Interval 31.3 to 47.8	27.2 percentage of participants Interval 19.9 to 35.0

Adverse Events

Gilteritinib

Serious events: 92 serious events

Other events: 175 other events

Deaths: 42 deaths

Placebo

Serious events: 81 serious events

Other events: 169 other events

Deaths: 44 deaths

Serious adverse events

Measure	Gilteritinib n=178 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=177 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 Agranulocytosis	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Blood and lymphatic system disorders Anaemia	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Blood and lymphatic system disorders Cytopenia	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Blood and lymphatic system disorders Febrile neutropenia	3.4% 6/178 • Number of events 6 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	1.1% 2/177 • Number of events 3 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Blood and lymphatic system disorders Haemolysis	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Blood and lymphatic system disorders Neutropenia	2.2% 4/178 • Number of events 4 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Blood and lymphatic system disorders Thrombocytopenia	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Cardiac disorders Atrial fibrillation	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Cardiac disorders Cardiac failure	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	1.1% 2/177 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Cardiac disorders Cardiomyopathy	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Cardiac disorders Coronary artery occlusion	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Cardiac disorders Pericardial effusion	1.1% 2/178 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Cardiac disorders Prinzmetal angina	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Congenital, familial and genetic disorders Antithrombin III deficiency	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Congenital, familial and genetic disorders Phimosis	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Ear and labyrinth disorders Deafness	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Ear and labyrinth disorders Deafness neurosensory	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Endocrine disorders Adrenal insufficiency	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Abdominal pain	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Colitis	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Colitis ulcerative	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Diarrhoea	1.1% 2/178 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Dyspepsia	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Large intestine polyp	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Nausea	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Vomiting	0.56% 1/178 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
General disorders Death	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
General disorders Polyserositis	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
General disorders Pyrexia	2.2% 4/178 • Number of events 5 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	2.3% 4/177 • Number of events 4 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Hepatobiliary disorders Bile duct stone	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	1.1% 2/177 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Hepatobiliary disorders Hepatic function abnormal	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Hepatobiliary disorders Liver disorder	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Immune system disorders Acute graft versus host disease	10.7% 19/178 • Number of events 24 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	12.4% 22/177 • Number of events 27 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Immune system disorders Acute graft versus host disease in liver	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Immune system disorders Chronic graft versus host disease	5.6% 10/178 • Number of events 10 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	4.5% 8/177 • Number of events 8 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Immune system disorders Graft versus host disease	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Immune system disorders Graft versus host disease in gastrointestinal tract	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Immune system disorders Graft versus host disease in liver	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Immune system disorders Graft versus host disease in lung	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Appendicitis	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Bacteraemia	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Bronchopulmonary aspergillosis allergic	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Central nervous system infection	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Clostridium difficile colitis	1.1% 2/178 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Cystitis bacterial	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Gastroenteritis	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Lower respiratory tract infection	1.7% 3/178 • Number of events 3 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Neutropenic sepsis	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Ophthalmic herpes zoster	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Pharyngeal abscess	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Pneumonia	9.0% 16/178 • Number of events 20 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	3.4% 6/177 • Number of events 7 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Pneumonia bacterial	1.1% 2/178 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Pneumonia fungal	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Pneumonia pseudomonal	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Pseudomembranous colitis	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Sepsis	1.7% 3/178 • Number of events 5 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Urinary tract infection bacterial	1.7% 3/178 • Number of events 4 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Viral haemorrhagic cystitis	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Injury, poisoning and procedural complications Accidental overdose	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Injury, poisoning and procedural complications Fall	1.1% 2/178 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Injury, poisoning and procedural complications Femoral neck fracture	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Injury, poisoning and procedural complications Femur fracture	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	1.1% 2/177 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Injury, poisoning and procedural complications Hip fracture	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Injury, poisoning and procedural complications Incorrect dose administered	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Injury, poisoning and procedural complications Medication error	2.2% 4/178 • Number of events 4 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	3.4% 6/177 • Number of events 6 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Injury, poisoning and procedural complications Stress fracture	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Alanine aminotransferase increased	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Aspartate aminotransferase increased	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Blood creatinine increased	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Blood glucose increased	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Electrocardiogram QT prolonged	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Hepatic enzyme increased	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Liver function test increased	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Neutrophil count decreased	2.2% 4/178 • Number of events 5 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Platelet count decreased	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Troponin increased	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Metabolism and nutrition disorders Fluid overload	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Metabolism and nutrition disorders Hyperglycaemia	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Metabolism and nutrition disorders Hyperkalaemia	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Metabolism and nutrition disorders Hyponatraemia	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Musculoskeletal and connective tissue disorders Muscular weakness	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Musculoskeletal and connective tissue disorders Myalgia	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Musculoskeletal and connective tissue disorders Polymyositis	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	2.8% 5/177 • Number of events 5 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large granular lymphocytosis	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemic retinopathy	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal squamous cell carcinoma	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Post transplant lymphoproliferative disorder	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Nervous system disorders Cerebral haemorrhage	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Nervous system disorders Encephalopathy	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Nervous system disorders Lacunar stroke	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Nervous system disorders Loss of consciousness	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Nervous system disorders Motor neurone disease	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Nervous system disorders Myelitis transverse	0.56% 1/178 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Nervous system disorders Neuralgia	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Nervous system disorders Seizure	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Nervous system disorders Syncope	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Pregnancy, puerperium and perinatal conditions Unintended pregnancy	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Psychiatric disorders Psychotic disorder	0.56% 1/178 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Psychiatric disorders Somatic symptom disorder	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Psychiatric disorders Suicidal ideation	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Renal and urinary disorders Acute kidney injury	3.4% 6/178 • Number of events 8 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	2.3% 4/177 • Number of events 4 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Renal and urinary disorders Cystitis haemorrhagic	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Renal and urinary disorders Renal failure	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Renal and urinary disorders Renal impairment	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Reproductive system and breast disorders Vulvovaginal adhesion	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	1.7% 3/177 • Number of events 3 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Skin and subcutaneous tissue disorders Rash	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Social circumstances Miscarriage of partner	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Vascular disorders Deep vein thrombosis	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Vascular disorders Embolism	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Vascular disorders Vena cava thrombosis	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Adenoviral upper respiratory infection	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Adenovirus infection	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Arthritis infective	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations COVID-19	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Clostridial sepsis	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Clostridium difficile infection	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Cytomegalovirus colitis	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Cytomegalovirus enterocolitis	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Cytomegalovirus viraemia	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Device related infection	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Enterobacter sepsis	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Enterococcal sepsis	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Epstein-Barr viraemia	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Escherichia sepsis	1.7% 3/178 • Number of events 3 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	1.1% 2/177 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Escherichia urinary tract infection	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Eye infection	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Gastroenteritis norovirus	1.1% 2/178 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Gastrointestinal infection	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Genital infection bacterial	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Herpes zoster	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Influenza	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	1.1% 2/177 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Klebsiella sepsis	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Lower respiratory tract infection bacterial	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Lower respiratory tract infection fungal	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Lower respiratory tract infection viral	1.1% 2/178 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	1.1% 2/177 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Oesophageal infection	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Oral candidiasis	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Pneumocystis jirovecii pneumonia	1.1% 2/178 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Pneumonia mycoplasmal	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Pseudomonal sepsis	1.1% 2/178 • Number of events 4 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Pseudomonas infection	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Respiratory syncytial virus infection	3.4% 6/178 • Number of events 6 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	1.7% 3/177 • Number of events 3 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Respiratory tract infection bacterial	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Respiratory tract infection fungal	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Respiratory tract infection viral	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Septic shock	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Staphylococcal sepsis	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Staphylococcal skin infection	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Streptococcal bacteraemia	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Tonsillitis	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Upper respiratory tract infection bacterial	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Urinary tract infection	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Viraemia	0.56% 1/178 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Viral sepsis	1.7% 3/178 • Number of events 3 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Viral skin infection	0.00% 0/178 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Viral upper respiratory tract infection	1.7% 3/178 • Number of events 3 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.

Other adverse events

Measure	Gilteritinib n=178 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=177 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	16.9% 30/178 • Number of events 36 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	11.3% 20/177 • Number of events 24 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Blood and lymphatic system disorders Neutropenia	12.9% 23/178 • Number of events 30 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	6.2% 11/177 • Number of events 13 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Blood and lymphatic system disorders Thrombocytopenia	12.4% 22/178 • Number of events 29 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	7.3% 13/177 • Number of events 14 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Eye disorders Dry eye	10.7% 19/178 • Number of events 21 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	11.9% 21/177 • Number of events 21 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Abdominal pain	6.2% 11/178 • Number of events 13 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	6.2% 11/177 • Number of events 13 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Constipation	11.2% 20/178 • Number of events 22 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	6.8% 12/177 • Number of events 14 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Diarrhoea	24.7% 44/178 • Number of events 55 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	16.9% 30/177 • Number of events 48 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Dry mouth	12.4% 22/178 • Number of events 26 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	8.5% 15/177 • Number of events 17 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Nausea	21.3% 38/178 • Number of events 48 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	22.6% 40/177 • Number of events 47 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Gastrointestinal disorders Vomiting	13.5% 24/178 • Number of events 34 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	15.8% 28/177 • Number of events 34 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
General disorders Fatigue	16.9% 30/178 • Number of events 40 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	15.8% 28/177 • Number of events 29 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
General disorders Non-cardiac chest pain	5.6% 10/178 • Number of events 11 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.56% 1/177 • Number of events 1 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
General disorders Oedema peripheral	15.7% 28/178 • Number of events 30 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	12.4% 22/177 • Number of events 27 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
General disorders Pyrexia	9.0% 16/178 • Number of events 20 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	9.0% 16/177 • Number of events 20 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Alanine aminotransferase increased	18.5% 33/178 • Number of events 44 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	12.4% 22/177 • Number of events 26 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Aspartate aminotransferase increased	16.3% 29/178 • Number of events 40 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	11.9% 21/177 • Number of events 24 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Blood alkaline phosphatase increased	8.4% 15/178 • Number of events 18 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	7.3% 13/177 • Number of events 13 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Blood creatine phosphokinase increased	18.5% 33/178 • Number of events 41 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	1.7% 3/177 • Number of events 3 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Blood creatinine increased	9.6% 17/178 • Number of events 22 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	6.8% 12/177 • Number of events 21 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Blood lactate dehydrogenase increased	5.1% 9/178 • Number of events 11 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	0.00% 0/177 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Neutrophil count decreased	27.5% 49/178 • Number of events 64 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	9.6% 17/177 • Number of events 43 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations Platelet count decreased	18.0% 32/178 • Number of events 44 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	9.6% 17/177 • Number of events 21 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Investigations White blood cell count decreased	12.4% 22/178 • Number of events 31 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	4.5% 8/177 • Number of events 8 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Metabolism and nutrition disorders Decreased appetite	6.2% 11/178 • Number of events 12 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	10.2% 18/177 • Number of events 26 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Metabolism and nutrition disorders Hyperglycaemia	7.3% 13/178 • Number of events 15 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	1.7% 3/177 • Number of events 3 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Metabolism and nutrition disorders Hyperkalaemia	5.1% 9/178 • Number of events 10 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	1.1% 2/177 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Metabolism and nutrition disorders Hypokalaemia	9.6% 17/178 • Number of events 23 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	2.3% 4/177 • Number of events 8 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Metabolism and nutrition disorders Hypomagnesaemia	7.3% 13/178 • Number of events 17 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	6.8% 12/177 • Number of events 25 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Metabolism and nutrition disorders Hypophosphataemia	5.1% 9/178 • Number of events 14 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	2.8% 5/177 • Number of events 6 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Musculoskeletal and connective tissue disorders Arthralgia	7.9% 14/178 • Number of events 15 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	6.8% 12/177 • Number of events 13 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Musculoskeletal and connective tissue disorders Back pain	9.0% 16/178 • Number of events 19 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	4.5% 8/177 • Number of events 9 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Musculoskeletal and connective tissue disorders Muscle spasms	7.3% 13/178 • Number of events 13 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	3.4% 6/177 • Number of events 6 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Musculoskeletal and connective tissue disorders Myalgia	10.1% 18/178 • Number of events 19 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	5.1% 9/177 • Number of events 13 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Musculoskeletal and connective tissue disorders Pain in extremity	8.4% 15/178 • Number of events 17 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	3.4% 6/177 • Number of events 6 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Nervous system disorders Dizziness	13.5% 24/178 • Number of events 34 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	7.9% 14/177 • Number of events 15 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Nervous system disorders Headache	10.7% 19/178 • Number of events 23 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	7.3% 13/177 • Number of events 17 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Nervous system disorders Neuropathy peripheral	5.1% 9/178 • Number of events 10 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	2.3% 4/177 • Number of events 5 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Nervous system disorders Paraesthesia	5.1% 9/178 • Number of events 10 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	4.0% 7/177 • Number of events 7 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Nervous system disorders Peripheral sensory neuropathy	5.1% 9/178 • Number of events 9 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	1.1% 2/177 • Number of events 2 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Psychiatric disorders Anxiety	5.6% 10/178 • Number of events 10 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	2.3% 4/177 • Number of events 4 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Psychiatric disorders Insomnia	7.9% 14/178 • Number of events 15 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	9.6% 17/177 • Number of events 19 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Respiratory, thoracic and mediastinal disorders Cough	18.5% 33/178 • Number of events 40 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	16.9% 30/177 • Number of events 39 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.6% 17/178 • Number of events 21 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	7.3% 13/177 • Number of events 15 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.2% 11/178 • Number of events 12 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	5.1% 9/177 • Number of events 11 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.2% 4/178 • Number of events 4 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	5.1% 9/177 • Number of events 13 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Skin and subcutaneous tissue disorders Dry skin	7.9% 14/178 • Number of events 16 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	4.0% 7/177 • Number of events 7 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Skin and subcutaneous tissue disorders Pruritus	7.3% 13/178 • Number of events 13 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	7.3% 13/177 • Number of events 15 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Skin and subcutaneous tissue disorders Rash	5.6% 10/178 • Number of events 13 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	9.0% 16/177 • Number of events 22 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.7% 12/178 • Number of events 13 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	5.1% 9/177 • Number of events 11 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Vascular disorders Hypertension	15.7% 28/178 • Number of events 35 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	7.3% 13/177 • Number of events 21 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Immune system disorders Acute graft versus host disease	37.6% 67/178 • Number of events 90 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	36.2% 64/177 • Number of events 91 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Immune system disorders Chronic graft versus host disease	52.8% 94/178 • Number of events 156 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	43.5% 77/177 • Number of events 131 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Cytomegalovirus viraemia	4.5% 8/178 • Number of events 10 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	6.8% 12/177 • Number of events 16 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Influenza	6.2% 11/178 • Number of events 11 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	2.8% 5/177 • Number of events 5 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Pneumonia	4.5% 8/178 • Number of events 9 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	5.6% 10/177 • Number of events 12 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Upper respiratory tract infection	11.8% 21/178 • Number of events 25 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	12.4% 22/177 • Number of events 34 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.
Infections and infestations Viral upper respiratory tract infection	10.1% 18/178 • Number of events 21 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.	6.2% 11/177 • Number of events 11 • All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.

Additional Information

Clinical Transparency

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Results disclosure agreements

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