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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001790-41 | EudraCT Number |
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This was a clinical study for adult participants who were recently diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some participants with AML have a mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called FLT3. This protein causes the leukemia cells to grow faster.
For participants with AML who could not receive standard chemotherapy, azacitidine (also known as Vidaza®) was a current standard of care treatment option in the United States. This clinical study tested an experimental medicine called ASP2215, also known as gilteritinib. Gilteritinib worked by stopping the leukemia cells from making the FLT3 protein. This helped stop the leukemia cells from growing faster.
This study compared two different treatments. Participants were assigned to one of these two groups by chance: a medicine called azacitidine, also known as Vidaza®, or an experimental medicine gilteritinib in combination with azacitidine. There was a twice as much chance to receive both medicines combined than azacitidine alone. The clinical study may help show which treatment helps patients live longer.
Participants considered an adult according to local regulation at the time of obtaining informed consent participated in the study.
Safety Cohort Prior to initiation of the randomized trial, 15 participants were enrolled to evaluate the safety and tolerability of ASP2215 given with azacitidine therapy in the study population.
Randomized Trial Approximately 250 participants were randomized in a 2:1 ratio to receive ASP2215 plus azacitidine (Arm AC) or azacitidine only (Arm C). Participants entered the screening period up to 14 days prior to the start of treatment. Participants administered treatment over 28-day cycles.
Earlier protocol versions included a 1:1:1 randomization ratio to receive Arm A: ASP2215, Arm AC: ASP2215 + azacitidine or Arm C: azacitidine. Participants previously randomized to Arm A continued following treatment and assessments as outlined in the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Cohort: Gilteritinib + Azacitidine (AZA) | Experimental | Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
|
| Randomized Cohort: Gilteritinib + AZA | Experimental | Participants received 120 mg(3 tablets of 40 mg)of gilteritinib orally once daily for continuous 28-day cycles in combination with 75mg/m^2 of AZA daily via subcutaneous injection or IV infusion for 7days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator,unacceptable toxicity occurred,or the participant met another treatment discontinuation criterion.After the end of treatment period,participants were followed up for 30-day follow up period.Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment,EQ-5D-5L,remission status and survival (cause and date of death).Participants in long-term follow-up who were no longer receiving treatment were followed every 3months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study,as further survival data were no longer needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gilteritinib | Drug | Tablet, oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from the date of randomization until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact. Kaplan-Meier (KM) estimates was used for analysis. | From the date of randomization until the date of death from any cause ( maximum duration up to 79 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival (EFS) | EFS: time from the date of randomization until the date of documented relapse from Complete Remission (CR), treatment failure(failing to achieve CR within 6 cycles of treatment) or death from any cause, whichever occurred first. CR: bone marrow(BM) regenerating normal hematopoietic cells, morphologically leukemia-free state, absolute neutrophil count (ANC) ≥1 × 10^9/L, platelet count ≥100 × 10^9/L, normal marrow differential with <5% myeloblast counts, missing/≤2% peripheral blood blast counts and being red blood cell (RBC) and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. Relapse: reappearance of leukemic blasts >2% in the peripheral blood/≥ 5% myeloblasts in the BM unattributable to any other cause/new/reappearance of extramedullary leukemia. |
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Inclusion Criteria:
Subject is considered an adult according to local regulation at the time of obtaining informed consent.
Subject has a diagnosis of previously-untreated AML according to World Health Organization (WHO) classification [Swerdlow et al, 2008] as determined by pathology review at the treating institution.
Subject is positive for FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD] [D835/I836] mutation) (or for Korea only: ITD alone or ITD with concurrent TKD activating mutation) in bone marrow or whole blood as determined by central laboratory. Note: Only requirement of FLT3 mutation assessment by central laboratory is only applicable to the randomization portion of the study.
Subject is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:
Subject must meet the following criteria as indicated on the clinical laboratory tests:
Subject is suitable for oral administration of study drug.
Female subject is eligible to participate if female subject is not pregnant and at least one of the following conditions applies:
Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 60 days after the final study drug administration.
Female subject must not donate ova starting at screening and throughout the study period, and for 180 days after the final study drug administration.
Male subject with female partners of childbearing potential must agree to use contraception as detailed in Contraception Requirements, starting at screening and continue throughout the study period, and for 120 days after the final study drug administration.
Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration.
Subject agrees not to participate in another interventional study while on treatment.
Exclusion Criteria:
Subject was diagnosed as acute promyelocytic leukemia (APL).
Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
Subject has received previous therapy for AML, with the exception of the following:
Subject has clinically active central nervous system leukemia.
Subject has been diagnosed with another malignancy that requires concurrent treatment (with the exception of hormone therapy limited to those therapies that prevent recurrence and/or spread of cancer) or hepatic malignancy regardless of need for treatment.
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 CYP3A/P-glycoprotein (P-gp).
Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-gp with the exception of drugs that are considered absolutely essential for the care of the subject.
Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.
Subject has congestive heart failure classified as New York Heart Association Class IV.
Subject with mean Fridericia-corrected QT interval (QTcF) > 480 ms at screening based on central reading.
Subject with a history of Long QT Syndrome at screening.
[Ex-US Only]: Subject has known pulmonary function tests with diffusion capacity of lung for carbon monoxide (DLCO) ≤ 50%, forced expiratory volume in the first second (FEV1) ≤ 60%, dyspnea at rest or requiring oxygen or any pleural neoplasm (Transient use of supplemental oxygen is allowed.)
Subject has active hepatitis B or C or other active hepatic disorder.
Subject has any condition which makes the subject unsuitable for study participation, including any contraindications of azacitidine.
Subject has a known or suspected hypersensitivity to ASP2215, azacitidine or any components of the formulations used.
[US Only]: Subject is ≥ 65 to 74 years of age, suitable for and willing to receive intensive induction chemotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA David Geffen School of Medicine | Los Angeles | California | 90095 | United States | ||
| University of California, Irvine Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35917453 | Derived | Wang ES, Montesinos P, Minden MD, Lee JH, Heuser M, Naoe T, Chou WC, Laribi K, Esteve J, Altman JK, Havelange V, Watson AM, Gambacorti-Passerini C, Patkowska E, Liu S, Wu R, Philipose N, Hill JE, Gill SC, Rich ES, Tiu RV. Phase 3 trial of gilteritinib plus azacitidine vs azacitidine for newly diagnosed FLT3mut+ AML ineligible for intensive chemotherapy. Blood. 2022 Oct 27;140(17):1845-1857. doi: 10.1182/blood.2021014586. |
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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Prior to randomized cohort, participants were enrolled for safety cohort to evaluate safety and tolerability of gilteritinib given with azacitidine therapy.
Participants with newly diagnosed, FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML) not eligible for intensive induction were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Safety Cohort: Gilteritinib + Azacitidine (AZA) | Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Safety Cohort: Approximately 5 Years |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2022 | Jul 16, 2025 |
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| Randomized Cohort: AZA |
| Experimental |
Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
|
| Randomized Cohort: Gilteritinib | Active Comparator | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
|
|
| azacitidine | Drug | Subcutaneous injection or intravenous infusion |
|
| From the date of randomization until the date of documented relapse from CR, treatment failure or death from any cause, whichever occurred first (up to 39.7 months) |
| Percentage of Participants With Best Response | Best response for a participant was defined as the best measured response (in the order of CR, CR with Incomplete Platelet Recovery (CRp), CR with Incomplete Hematologic Recovery (CRi), and treatment failure) from all post-baseline visits. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10^9/L, platelet count ≥100 × 10^9/L, normal marrow differential with <5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (< 100 × 10^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required. | From the date of randomization until the date of death from any cause (up to 57 months) |
| Completed Remission (CR) Rate | CR rate: number of participants who achieved the best response of CR divided by the number of participants in the analysis population. Participants with unknown or missing response, or who provided no information on response at the end of treatment were included in the denominator when calculating rates. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10^9/L, platelet count ≥100 × 10^9/L, normal marrow differential with <5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent(1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. | From the date of randomization until the date of death from any cause (approximately 49.7 months) |
| CRc Rate | CRc rate was defined as participants with best response of (CR + CRp + CRi) divided by the number of participants in the analysis population. Participants were classified as: CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10^9/L, platelet count ≥100 × 10^9/L, normal marrow differential with <5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (< 100 × 10^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required. Percentage of participants with CRc was reported. | From the date of randomization until the date of death from any cause (approximately 54.5 months) |
| Complete Remission With Partial Hematologic Recovery (CRh) | CRh was defined as the response at a post baseline visit as CRh having bone marrow myeloblast count < 5%, partial hematologic recovery ANC ≥ 0.5 x 10^9/L and platelets ≥ 50 x 10^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood must be ≤ 2% or missing. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10^9/L, platelet count ≥100 × 10^9/L, normal marrow differential with <5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. Percentage of participants with CRh was reported. | From the date of randomization until the date of death from any cause (up to 49.7 months) |
| CR/CRh Rate | CR/CRh rate: number of participants who achieved CR or CRh divided by the number of participants in the analysis population. CR/CRh: CR/CRh if it fulfilled criteria for CR or CRh at the visit. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10^9/L, platelet count ≥100 × 10^9/L, normal marrow differential with <5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRh: response at a post baseline visit as CRh having bone marrow myeloblast count < 5%, partial hematologic recovery ANC ≥ 0.5 x 10^9/L and platelets ≥ 50 x 10^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood must be ≤ 2% or missing. Percentage of participants with CR/CRh was reported. | From the date of randomization until the date of death from any cause (up to 49.7 months) |
| Percentage of Participants With Transfusion Conversion Rate | Transfusion conversion rate was defined as the number of participants who were transfusion dependent at baseline period but became transfusion independent at post-baseline period divided by the total number of participants who were transfusion dependent at baseline period. | From baseline up to 57 months |
| Percentage of Participants With Transfusion Maintenance Rate | Transfusion maintenance rate was defined as the number of participants who were transfusion independent at baseline period and remained transfusion independent post-baseline period divided by the total number of participants who were transfusion independent at baseline period. | From baseline up to 57 months |
| Leukemia-free Survival (LFS) | LFS: time from the date of first CRc (CR + CRp + CRi) until the date of documented relapse (excluding relapse from PR) or death for participants who achieved CRc. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10^9/L, platelet count ≥100 × 10^9/L, normal marrow differential with <5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (< 100 × 10^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required. CRc: fulfilled criteria for CR, CRp or CRi. Based on KM estimates. | From first day of achieving first CRc to the first day of confirmed relapse/death (up to 54.5 months) |
| Duration of Remission | Duration of remission included CRc, CR, CRh, CR/CRh, and response duration [CRc + PR]. Duration of CRc, CR, CRh: the time from the date of first CRc until the date of first documented relapse for participants who achieved CRc, CR, and CRh, respectively. CR/CRh: fulfilled criteria for CR or CRh at the visit. CRh: marrow blasts <5%, ANC ≥0.5×10^9/L, platelets ≥50×10^9/L, not meeting CR criteria. PR: If marrow myeloblasts between <5% and 25% and ≤2% or missing peripheral blood blast and a decrease from baseline of at least 50% in the marrow myeloblasts and no evidence of extramedullary leukemia, the response was classified as PR. If marrow myeloblasts <5% and ≤2% or missing peripheral blood blast and no evidence of extramedullary leukemia, the response was classified as PR even with Auer rods. | From first day of achieving first response to the first day of confirmed relapse/death (up to 56.4 months) |
| Change From Baseline in Brief Fatigue Inventory (BFI) | The BFI was a tool to assess fatigue severity and impact on daily function in cancer participants over 24 hours. It included 9 items. A global fatigue score was computed by averaging the scores of the 9 items measured on the numeric rating scale. Scores were calculated if ≥5 of 9 items were answered. A higher score indicates a higher degree of fatigue. The first 3 rate fatigue from 0 (no fatigue) to 10 (worst imaginable), with higher scores indicating worse outcomes. The remaining 6 assess how fatigue interferes with daily activities from 0 (no interference) to 10 (completely interferes). A global fatigue score (0-10) was the average of all items, with higher scores indicating worse fatigue. Overall BFI score is reported. | From baseline to 31 months |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE was defined as an adverse event observed after starting administration of the study drug until 30 days from the last study treatment | From first dose up to end of study duration (101 months) |
| Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores | ECOG performance scores at each assessment time were be provided by treatment group. Negative change scores indicated an improvement and positive scores indicate a decline in performance. The grades were defined as follows: 0: Fully active, able to carry on all pre-disease performance without restriction.
| From baseline to end of treatment (up to 57 months) |
| Orange |
| California |
| 92868 |
| United States |
| Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 60611-5975 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| St. Louis University Cancer Center - Hematology/Oncology | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center - John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Hematology-Oncology Associates of Northern NJ | Morristown | New Jersey | 07962 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Weill Cornell Medical College-New York Presbyterian Hospital | New York | New York | 10021 | United States |
| GHS Cancer Institute | Greenville | South Carolina | 26615 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Site AU61004 | Liverpool | New South Wales | 2170 | Australia |
| Site AU61008 | Adelaide | South Australia | SA 5000 | Australia |
| Site AU61007 | Geelong | Victoria | 3220 | Australia |
| Site BE32007 | Brussels | Brussels Capital | 1090 | Belgium |
| Site BE32003 | Brussels | Bruxelles-Capitale, Region de | 1200 | Belgium |
| Site BE32006 | Ghent | 9000 | Belgium |
| Site CA15009 | Edmonton | Alberta | T6G 2B7 | Canada |
| Site CA15011 | Toronto | Ontario | M4N 3M5 | Canada |
| Site CA15002 | Toronto | Ontario | M5G 2M9 | Canada |
| Site CA15006 | Montreal | Quebec | H4A 3J1 | Canada |
| Site FR33003 | Nîmes | Gard | 30029 | France |
| Site FR33002 | Pessac | Gironde | 33604 | France |
| Site FR33015 | Rouen | Haute-Normandie | 76038 | France |
| Site FR33019 | Montpellier | Herault | 34295 | France |
| Site FR33018 | Rennes | Ille-et-Vilaine | 35033 | France |
| Site FR33001 | Nantes | Loire-Atlantique | 44093 | France |
| Site FR33023 | Valenciennes | Nord | 59322 | France |
| Site FR33013 | Pierre-Bénite | Rhone | 69310 | France |
| Site FR33017 | Le Mans | Sarthe | 72037 | France |
| Site FR33012 | Poitiers | Vienne | 86000 | France |
| Site FR33009 | Angers | 49033 | France |
| Site FR33020 | Bayonne | France |
| Site FR33004 | Lille | 59020 | France |
| Site FR33006 | Lille | 59037 | France |
| Site DE49002 | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Site DE49007 | München | Bavaria | 81737 | Germany |
| Site DE49005 | Frankfurt am Main | Hesse | 60590 | Germany |
| Site DE49012 | Braunschweig | Lower Saxony | 38118 | Germany |
| Site DE49004 | Hanover | Lower Saxony | 30625 | Germany |
| Site DE49015 | Rostock | Mecklenburg-Vorpommern | 18057 | Germany |
| Site DE49009 | Halle | Saxony-Anhalt | 06120 | Germany |
| Site DE49003 | Berlin | 13353 | Germany |
| Site DE49011 | Stuttgart | 70376 | Germany |
| Site IT39009 | Ancona | 60126 | Italy |
| Site IT39015 | Bologna | 40138 | Italy |
| Site IT39012 | Florence | Italy |
| Site IT39004 | Milan | 20162 | Italy |
| Site IT39007 | Monza | Italy |
| Site IT39001 | Naples | 80131 | Italy |
| Site IT39014 | Novara | Italy |
| Site IT39006 | Palermo | 90146 | Italy |
| Site IT39005 | Pavia | Italy |
| Site IT39011 | San Giovanni Rotondo | 71013 | Italy |
| Site JP81018 | Anjo | Aichi-ken | Japan |
| Site JP81007 | Nagoya | Aichi-ken | Japan |
| Site JP81027 | Matsuyama | Ehime | Japan |
| Site JP81021 | Fukuyama | Hiroshima | Japan |
| Site JP81031 | Sapporo | Hokkaido | Japan |
| Site JP81033 | Sapporo | Hokkaido | Japan |
| Site JP81015 | Kobe | Hyōgo | Japan |
| Site JP81034 | Hitachi | Ibaraki | Japan |
| Site JP81023 | Kanazawa | Ishikawa-ken | Japan |
| Site JP81001 | Isehara | Kanagawa | Japan |
| Site JP81032 | Yokohama | Kanagawa | Japan |
| Site JP81012 | Sendai | Miyagi | Japan |
| Site JP81011 | Kurashiki | Okayama-ken | Japan |
| Site JP81029 | Shibuya-ku | Tokyo | Japan |
| Site JP81014 | Shinagawa-ku | Tokyo | Japan |
| Site JP81035 | Chiba | Japan |
| Site JP81008 | Fukuoka | Japan |
| Site JP81024 | Gifu | Japan |
| Site JP81005 | Kumamoto | Japan |
| Site JP81016 | Kyoto | Japan |
| Site JP81004 | Nagasaki | Japan |
| Site JP81017 | Nagasaki | Japan |
| Site JP81030 | Osaka | Japan |
| Site JP81036 | Osaka | Japan |
| Site JP81026 | Tokushima | Japan |
| Site JP81019 | Toyama | Japan |
| Site PL48003 | Lublin | Lublin Voivodeship | 20-081 | Poland |
| Site PL48004 | Warsaw | Masovian Voivodeship | 02-776 | Poland |
| Site PL48002 | Opole | Opole Voivodeship | 45-061 | Poland |
| Site PL48001 | Olsztyn | Warmian-Masurian Voivodeship | 10-228 | Poland |
| Site KR82003 | Namdong | Incheon Gwang'yeogsiv | 405 760 | South Korea |
| Site KR82013 | Seoul | Seoul Teugbyeolsi | 05505 | South Korea |
| Site KR82006 | Seoul | Seoul Teugbyeolsi | 110-744 | South Korea |
| Site KR82002 | Seoul | Seoul Teugbyeolsi | 137-701 | South Korea |
| Site KR82001 | Ulsan | Ulsan Gwang'yeogsi | 682-714 | South Korea |
| Site KR82014 | Busan | 49241 | South Korea |
| Site KR82010 | Hwasun-gun | South Korea |
| Site KR82015 | Seongnam-si | South Korea |
| Site KR82012 | Seoul | 156-707 | South Korea |
| Site ES34007 | Palma de Mallorca | Balearic Islands | 07010 | Spain |
| Site ES34003 | Oviedo | Principality of Asturias | 33011 | Spain |
| Site ES34008 | Barcelona | 08003 | Spain |
| Site ES34004 | Barcelona | 08035 | Spain |
| Site ES34010 | Barcelona | 08036 | Spain |
| Site ES34009 | Barcelona | 8041 | Spain |
| Site ES34002 | Cáceres | 10003 | Spain |
| Site ES34013 | Madrid | Spain |
| Site ES34005 | Valencia | 46026 | Spain |
| Site TW88604 | Kaohsiung City | 83301 | Taiwan |
| Site TW88605 | Kwei Shan Hsiang | Taiwan |
| Site TW88602 | Tainan | 704 | Taiwan |
| Site TW88609 | Tainan | 736 | Taiwan |
| Site TW88601 | Taipei | 10002 | Taiwan |
| Site TW88608 | Taipei | 10449 | Taiwan |
| Site TW88610 | Taipei | 11217 | Taiwan |
| Site GB44007 | Sheffield | S10 2JF | United Kingdom |
| FG001 | Randomized Cohort: Gilteritinib + AZA | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| FG002 | Randomized Cohort: AZA | Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| FG003 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Randomization: Approximately 3 Years |
|
|
| Long-term Follow-up: up to 3 Years |
|
|
The Full Analysis Set (FAS) was defined as the intention to treat set, which consisted of participants who were randomized and were used for efficacy analyses.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Safety Cohort: Gilteritinib + Azacitidine (AZA) | Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| BG001 | Randomized Cohort: Gilteritinib + AZA | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| BG002 | Randomized Cohort: AZA | Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| BG003 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Data reported for Race. | Count of Participants | Participants |
| |||||||||||||||
| Age group per Interactive Response Technology (IRT) | IRT is a system used in clinical trials to manage randomization, treatment allocation, and trial supply logistics. | Count of Participants | Participants |
| |||||||||||||||
| FMS-like tyrosine kinase 3 (FLT3) mutation type | FLT3 is a receptor tyrosine kinase that is expressed almost exclusively in the hematopoietic compartment. | Count of Participants | Participants |
| |||||||||||||||
| Cytogenetic risk status | The cytogenetic risk status was categorized as Favorable [Core binding factor: inv(16) or t(16;16) or t(8;21). Other cytogenetic abnormalities in addition to these do not alter better risk status], Intermediate [Normal cytogenetics, +8 alone, t(9;11), Other non-defined cytogenetic abnormality], or Unfavorable [Complex (≥ 3 clonal chromosomal abnormalities), Monosomal karyotype, -5, 5q-, -7, 7q-, 11q23 - non t(9;11), inv(3), t(3;3), t(6;9)] | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | OS was defined as the time from the date of randomization until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact. Kaplan-Meier (KM) estimates was used for analysis. | The full analysis set (FAS) was defined as the intention to treat set, which consisted of participants who were randomized and were used for efficacy analyses. | Posted | Median | 95% Confidence Interval | months | From the date of randomization until the date of death from any cause ( maximum duration up to 79 months) |
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| Secondary | Event-free Survival (EFS) | EFS: time from the date of randomization until the date of documented relapse from Complete Remission (CR), treatment failure(failing to achieve CR within 6 cycles of treatment) or death from any cause, whichever occurred first. CR: bone marrow(BM) regenerating normal hematopoietic cells, morphologically leukemia-free state, absolute neutrophil count (ANC) ≥1 × 10^9/L, platelet count ≥100 × 10^9/L, normal marrow differential with <5% myeloblast counts, missing/≤2% peripheral blood blast counts and being red blood cell (RBC) and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. Relapse: reappearance of leukemic blasts >2% in the peripheral blood/≥ 5% myeloblasts in the BM unattributable to any other cause/new/reappearance of extramedullary leukemia. | FAS population | Posted | Median | 95% Confidence Interval | months | From the date of randomization until the date of documented relapse from CR, treatment failure or death from any cause, whichever occurred first (up to 39.7 months) |
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| Secondary | Percentage of Participants With Best Response | Best response for a participant was defined as the best measured response (in the order of CR, CR with Incomplete Platelet Recovery (CRp), CR with Incomplete Hematologic Recovery (CRi), and treatment failure) from all post-baseline visits. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10^9/L, platelet count ≥100 × 10^9/L, normal marrow differential with <5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (< 100 × 10^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required. | FAS population | Posted | Number | percentage of participants | From the date of randomization until the date of death from any cause (up to 57 months) |
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| Secondary | Completed Remission (CR) Rate | CR rate: number of participants who achieved the best response of CR divided by the number of participants in the analysis population. Participants with unknown or missing response, or who provided no information on response at the end of treatment were included in the denominator when calculating rates. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10^9/L, platelet count ≥100 × 10^9/L, normal marrow differential with <5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent(1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. | FAS population | Posted | Number | percentage of participants | From the date of randomization until the date of death from any cause (approximately 49.7 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CRc Rate | CRc rate was defined as participants with best response of (CR + CRp + CRi) divided by the number of participants in the analysis population. Participants were classified as: CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10^9/L, platelet count ≥100 × 10^9/L, normal marrow differential with <5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (< 100 × 10^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required. Percentage of participants with CRc was reported. | FAS population | Posted | Number | percentage of participants | From the date of randomization until the date of death from any cause (approximately 54.5 months) |
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| Secondary | Complete Remission With Partial Hematologic Recovery (CRh) | CRh was defined as the response at a post baseline visit as CRh having bone marrow myeloblast count < 5%, partial hematologic recovery ANC ≥ 0.5 x 10^9/L and platelets ≥ 50 x 10^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood must be ≤ 2% or missing. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10^9/L, platelet count ≥100 × 10^9/L, normal marrow differential with <5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. Percentage of participants with CRh was reported. | FAS population | Posted | Number | percentage of participants | From the date of randomization until the date of death from any cause (up to 49.7 months) |
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| Secondary | CR/CRh Rate | CR/CRh rate: number of participants who achieved CR or CRh divided by the number of participants in the analysis population. CR/CRh: CR/CRh if it fulfilled criteria for CR or CRh at the visit. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10^9/L, platelet count ≥100 × 10^9/L, normal marrow differential with <5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRh: response at a post baseline visit as CRh having bone marrow myeloblast count < 5%, partial hematologic recovery ANC ≥ 0.5 x 10^9/L and platelets ≥ 50 x 10^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood must be ≤ 2% or missing. Percentage of participants with CR/CRh was reported. | FAS population | Posted | Number | percentage of participants | From the date of randomization until the date of death from any cause (up to 49.7 months) |
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| Secondary | Percentage of Participants With Transfusion Conversion Rate | Transfusion conversion rate was defined as the number of participants who were transfusion dependent at baseline period but became transfusion independent at post-baseline period divided by the total number of participants who were transfusion dependent at baseline period. | FAS population included participants who were transfusion dependent at baseline period. | Posted | Number | 95% Confidence Interval | percentage of participants | From baseline up to 57 months |
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| Secondary | Percentage of Participants With Transfusion Maintenance Rate | Transfusion maintenance rate was defined as the number of participants who were transfusion independent at baseline period and remained transfusion independent post-baseline period divided by the total number of participants who were transfusion independent at baseline period. | FAS population included participants who were transfusion independent at baseline period. | Posted | Number | 95% Confidence Interval | percentage of participants | From baseline up to 57 months |
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| Secondary | Leukemia-free Survival (LFS) | LFS: time from the date of first CRc (CR + CRp + CRi) until the date of documented relapse (excluding relapse from PR) or death for participants who achieved CRc. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10^9/L, platelet count ≥100 × 10^9/L, normal marrow differential with <5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (< 100 × 10^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required. CRc: fulfilled criteria for CR, CRp or CRi. Based on KM estimates. | FAS population included participants who had achieved CRc. | Posted | Median | 95% Confidence Interval | months | From first day of achieving first CRc to the first day of confirmed relapse/death (up to 54.5 months) |
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| Secondary | Duration of Remission | Duration of remission included CRc, CR, CRh, CR/CRh, and response duration [CRc + PR]. Duration of CRc, CR, CRh: the time from the date of first CRc until the date of first documented relapse for participants who achieved CRc, CR, and CRh, respectively. CR/CRh: fulfilled criteria for CR or CRh at the visit. CRh: marrow blasts <5%, ANC ≥0.5×10^9/L, platelets ≥50×10^9/L, not meeting CR criteria. PR: If marrow myeloblasts between <5% and 25% and ≤2% or missing peripheral blood blast and a decrease from baseline of at least 50% in the marrow myeloblasts and no evidence of extramedullary leukemia, the response was classified as PR. If marrow myeloblasts <5% and ≤2% or missing peripheral blood blast and no evidence of extramedullary leukemia, the response was classified as PR even with Auer rods. | FAS population with available data was analyzed. | Posted | Median | 95% Confidence Interval | months | From first day of achieving first response to the first day of confirmed relapse/death (up to 56.4 months) |
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| Secondary | Change From Baseline in Brief Fatigue Inventory (BFI) | The BFI was a tool to assess fatigue severity and impact on daily function in cancer participants over 24 hours. It included 9 items. A global fatigue score was computed by averaging the scores of the 9 items measured on the numeric rating scale. Scores were calculated if ≥5 of 9 items were answered. A higher score indicates a higher degree of fatigue. The first 3 rate fatigue from 0 (no fatigue) to 10 (worst imaginable), with higher scores indicating worse outcomes. The remaining 6 assess how fatigue interferes with daily activities from 0 (no interference) to 10 (completely interferes). A global fatigue score (0-10) was the average of all items, with higher scores indicating worse fatigue. Overall BFI score is reported. | FAS population with available data was analyzed. | Posted | Mean | Standard Deviation | Scores on scale | From baseline to 31 months |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE was defined as an adverse event observed after starting administration of the study drug until 30 days from the last study treatment | The Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine). | Posted | Number | participants | From first dose up to end of study duration (101 months) |
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| Secondary | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores | ECOG performance scores at each assessment time were be provided by treatment group. Negative change scores indicated an improvement and positive scores indicate a decline in performance. The grades were defined as follows: 0: Fully active, able to carry on all pre-disease performance without restriction.
| SAF population with available data was analyzed. | Posted | Number | participants | From baseline to end of treatment (up to 57 months) |
|
All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)
ACM: All randomized participants.
AEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Cohort: Gilteritinib + Azacitidine (AZA) | Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. | 14 | 15 | 14 | 15 | 15 | 15 |
| EG001 | Randomized Cohort: Gilteritinib + AZA | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. | 70 | 89 | 81 | 88 | 87 | 88 |
| EG002 | Randomized Cohort: AZA | Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. | 49 | 57 | 34 | 54 | 46 | 54 |
| EG003 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. | 22 | 22 | 20 | 22 | 22 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Torsade de pointes | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Antithrombin III deficiency | Congenital, familial and genetic disorders | MedDRA v23 | Systematic Assessment |
| |
| Retinitis pigmentosa | Congenital, familial and genetic disorders | MedDRA v23 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA v23 | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA v23 | Systematic Assessment |
| |
| Acquired macroglossia | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v23 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Organ failure | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Bacillus bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Bacterial urethritis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Clostridium bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Genital infection fungal | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Lower respiratory tract infection fungal | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Septic embolus | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Staphylococcus test positive | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Adult failure to thrive | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Central nervous system leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Chloroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Differentiation syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Central nervous system lesion | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Cluster headache | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Intracranial haematoma | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Prerenal failure | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Cardiac dysfunction | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v23 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA v23 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA v23 | Systematic Assessment |
| |
| Meibomian gland dysfunction | Eye disorders | MedDRA v23 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA v23 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Medical device pain | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Medical device site reaction | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Physical deconditioning | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Acinetobacter bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Enterobacter bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Lip infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Tongue fungal infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA v23 | Systematic Assessment |
|
Protocol versions 6.0 and earlier included a 1:1:1 randomization ratio to receive Gilteritinib + AZA, AZA-only and Gilteritinib-only. Randomization to arm Gilteritinib-only was removed in protocol version 7.0. Participants previously randomized to Gilteritinib-only arm continued following treatment and assessments as outlined in the protocol.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Transparency | Astellas Pharma Global Development, Inc. | 800-888-7704 | astellas.resultsdisclosure@astellas.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2022 | Jul 16, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609080 | gilteritinib |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided
| Disease Relapse |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Death |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Death |
|
| Miscellaneous |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Unknown |
|
| Other |
|
| >= 75 years |
|
| Tyrosine Kinase Domain (TKD) (D835/I836) Alone |
|
| ITD with TKD (D835/I836) |
|
| Others (unknown/missing/negative) |
|
| Intermediate |
|
| Unfavorable |
|
| Others (unknown, missing) |
|
| OG001 | Randomized Cohort: AZA | Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| OG002 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
|
|
|
| OG001 | Randomized Cohort: AZA | Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| OG002 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
|
|
| OG001 | Randomized Cohort: AZA | Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| OG002 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
|
|
|
| OG001 | Randomized Cohort: AZA | Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| OG002 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
|
|
|
| OG001 | Randomized Cohort: AZA | Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| OG002 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
|
|
|
| OG001 | Randomized Cohort: AZA | Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| OG002 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
|
|
|
| OG001 |
| Randomized Cohort: AZA |
Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| OG002 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
|
|
|
| OG001 |
| Randomized Cohort: AZA |
Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| OG002 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
|
|
|
| OG001 | Randomized Cohort: AZA | Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| OG002 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
|
|
|
| OG001 | Randomized Cohort: AZA | Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| OG002 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
|
|
|
| OG001 | Randomized Cohort: AZA | Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| OG002 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
|
|
|
| OG002 | Randomized Cohort: AZA | Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| OG003 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
|
|
Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.
| OG002 | Randomized Cohort: AZA | Participants received 75 mg/m^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed. |
| OG003 | Randomized Cohort: Gilteritinib | Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol. |
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