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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000140-42 | EudraCT Number |
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The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who were refractory to or had relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy, and determined the efficacy of ASP2215 therapy as assessed by the rate of complete remission and complete remission with partial hematological recovery (CR/CRh) in these participants. This study also determined the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.
Participants considered an adult according to local regulations at the time of signing informed consent participated in this study. Participants were randomized in a 2:1 ratio to receive ASP2215 or salvage chemotherapy. Participants entered the screening period up to 14 days prior to the start of treatment. Prior to randomization, a salvage chemotherapy regimen was pre-selected for each participant; options included low-dose cytarabine (LoDAC), azacitidine, mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC), or fludarabine, cytarabine, and granulocyte colony-stimulating factor (G-CSF) with idarubicin (FLAG-IDA). The randomization was stratified by response to first-line therapy and pre-selected salvage chemotherapy. Participants were administered treatment over continuous 28-day cycles. After treatment discontinuation, participants had a pre-hematopoietic stem cell transplant (HSCT)/end-of-treatment visit within 7 days after treatment discontinuation, followed by a 30-day follow-up for safety, in which a telephone contact with the participant was sufficient unless any assessment had to be repeated for resolution of treatment-related adverse events (AEs). After that, long term follow-up was done every 3 months up to 3 years from the participant's end-of-treatment visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gilteritinib | Experimental | Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. |
|
| Salvage Chemotherapy | Active Comparator | Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on MEC chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on FLAG-IDA chemotherapy received G-CSF 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gilteritinib | Drug | tablet, oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Overall Survival (OS) | Overall survival was defined as the time from the date of randomization until the date of death from any cause (death date - randomization date + 1). 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 (date of last contact - randomized date + 1). The date of last contact was the latest date that the participant was known to be alive. The last contact date was derived for participants alive at the analysis cutoff date. Survival rate and 95% CI were estimated using the Kaplan-Meier method and the Greenwood formula. | From randomization to until the date of death from any cause (median time of follow-up for OS was 17.8 months) |
| Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm | The CR/CRh rate was defined as the number of participants who achieved either CR or CRh divided by the number of participants in the analysis population. CR: For participants to be classified as being in CR at, they must have had bone marrow regenerating normal hematopoietic cells and achieved a morphologic leukemia-free state and must had an ANC ≥ 1 x 10^9/L and platelet count ≥ 100 x 10^9/L and normal marrow differential with < 5% blasts, and they were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There was no evidence of extramedullary leukemia. CRh: Participants were classified as CRh if they had marrow blasts < 5%, partial hematologic recovery ANC ≥ 0.5 x 10^9/L and platelets ≥ 50 x 10^9/L, no evidence of extramedullary leukemia and could not be classified as CR. | From the date of randomization up to at least 112 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Event-Free Survival (EFS) | EFS: time from randomization date up to date of documented relapse (excluding relapse after PR)/ treatment failure (failure to achieve CR, CRp, CRi /PR) /death, whichever occurred first. Relapse: leukemic blasts in peripheral blood 5/ ≥ 25% blasts in bone marrow (BM) aspirate due to no other cause/reappearance/new appearance of extramedullary leukemia. CR: BM regenerating normal hematopoietic cells, morphologic leukemia-free state, ANC ≥1x10^9/L, platelet count ≥100x10^9/L, normal marrow differential with <5% blasts, and RBC/platelet transfusion independent with no extramedullary leukemia. CRp: achieved CR except incomplete platelet recovery (<100x 0^9/L). CRi: criteria for CR fulfilled except incomplete hematological recovery with residual neutropenia <1x10^9/L with /without complete platelet recovery. PR: BM regenerating normal hematopoietic cells, peripheral recovery, no circulating blasts and decrease of 50% blasts in with total blasts between 5% -25% or, 5% if Auer rods present. |
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Inclusion Criteria:
Participant has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification (2008) as determined by pathology review at the treating institute.
Participant is refractory to or relapsed after first-line AML therapy (with or without hematopoietic stem cell transplant (HSCT)).
Refractory to first-line AML therapy is defined as:
1. Participant did not achieve complete remission/complete remission with incomplete hematologic recovery/complete remission with incomplete platelet recovery (CR/CRi/CRp) under initial therapy. A Participant eligible for standard therapy must receive at least one cycle of an anthracycline containing induction block in standard dose for the selected induction regimen. A Participant not eligible for standard therapy must have received at least one complete block of induction therapy seen as the optimum choice of therapy to induce remission for this subject.
Untreated first hematologic relapse is defined as:
Participant is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab. A Participant with rapidly proliferative disease and unable to wait for the central lab results can be enrolled based on a local test performed after completion of the last interventional treatment. Participants can be enrolled from a local test result if they have any of the following FLT3 mutations: FLT3 internal tandem duplication (ITD), FLT3 tyrosine kinase domain (TKD)/D835 or FLT3- TKD/I836.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Participant is eligible for pre-selected salvage chemotherapy.
Participant must meet the following criteria as indicated on the clinical laboratory tests:
Participant is suitable for oral administration of study drug.
Female Participant must either:
Be of non-child bearing potential:
Or, if of childbearing potential,
Female Participant must agree not to breastfeed at Screening and throughout the study period and for 60 days after the final study drug administration.
Female Participant must not donate ova starting at Screening and throughout the study period and for 180 days after the final study drug administration.
Male Participant and their female partners who are of childbearing potential must be using highly effective contraception per locally accepted standards in addition to a barrier method starting at Screening and continue throughout the study period and for 120 days after the final study drug administration.
Male Participant must not donate sperm starting at Screening and throughout the study period and 120 days after the final study drug administration.
Participant agrees not to participate in another interventional study while on treatment.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Executive Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site US10011 | Birmingham | Alabama | 35294-0006 | United States | ||
| Site US10012 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37019445 | Derived | Ritchie EK, Cella D, Fabbiano F, Pigneux A, Kanda Y, Ivanescu C, Pandya BJ, Shah MV. Patient-reported outcomes from the phase 3 ADMIRAL trial in patients with FLT3-mutated relapsed/refractory AML. Leuk Lymphoma. 2023 May;64(5):938-950. doi: 10.1080/10428194.2023.2186731. Epub 2023 Apr 5. | |
| 35130342 | Derived |
| Label | URL |
|---|---|
| Link to results and other applicable study documents on the Astellas Clinical Trials website | View source |
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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.
Participants entered the screening period up to 14 days prior to the start of treatment. Prior to randomization, the investigator preselected a salvage chemotherapy for each participant. The randomization was stratified by response to first-line AML therapy and preselected salvage chemotherapy. Treatment was given over continuous 28-day cycles.
Participants were recruited from approximately 140 centers in North America, Europe, Asia and the rest of the world and randomized in a 2:1 ratio to receive gilteritinib or salvage chemotherapy. Participants had FMS-like tyrosine kinase 3 (FLT3) mutations and relapsed or refractory acute myeloid leukemia (AML) after first-line therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gilteritinib | Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomization Period: Up to 3 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 | Dec 7, 2020 | Aug 11, 2025 |
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| LoDAC (Low Dose Cytarabine) | Drug | subcutaneous (SC) or intravenous (IV) injection |
|
| Azacitidine | Drug | SC or IV injection |
|
| MEC (Mitoxantrone, Etoposide, Cytarabine) | Drug | IV injection |
|
| FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin) | Drug | SC (G-CSF) and IV (Fludarabine, Cytarabine, Idarubicin) injection |
|
| From the date of randomization until the date of documented relapse, treatment failure or death from any cause (median time of follow-up was 17.8 months) |
| Percentage of Participants With Complete Remission (CR) Rate | The CR rate was defined as the number of participants who achieved the best response of CR divided by the number of participants in the analysis population. CR: For participants to be classified as being in CR, they must have had bone marrow regenerating normal hematopoietic cells and achieved a morphologic leukemia-free state and must had an ANC ≥ 1 x 10^9/L and platelet count ≥ 100 x 10^9/L and normal marrow differential with < 5% blasts, and they were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There was no evidence of extramedullary leukemia. | From the date of randomization up to at least 6 months |
| Duration of Leukemia-Free Survival (LFS) | LFS: time from the date of first CRc until the date of documented relapse or death for subjects who achieve CRc. For a subject who is not known to have relapsed or died, LFS is censored on the date of last relapse-free disease assessment date. CRc: achieved CR, CRp or CRi. Relapse: leukemic blasts in peripheral blood/ ≥ 25% blasts in bone marrow (BM) aspirate not due to any other cause/reappearance/new appearance of extramedullary leukemia. CR: BM regenerating normal hematopoietic cells, morphologic leukemia-free state, ANC ≥ 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, normal marrow differential with < 5% blasts, and RBC/platelet transfusion independent with no extramedullary leukemia. CRp: achieved CR except incomplete platelet recovery (< 100 x 10^9/L). CRi : criteria for CR fulfilled except incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with /without complete platelet recovery.. | From the date of first CRc until the date of documented relapse or death for participants who achieved CRc (median time of follow-up was 17.8 months) |
| Duration of Remission | Duration of remission included duration of CRc, CR/CRh, CRh, CR, CRi, CRp (defined as the time from the date of first CRc until the date of first documented relapse for participants who achieved CRc, CR/CRh, CRh, CR, CRi, CRp respectively) and duration of response (CRc + PR). CRc: achieved CR, CRp or CRi at the visit. CR: BM regenerating normal hematopoietic cells, morphologic leukemia-free state, ANC ≥1x10^9/L, platelet count ≥100x10^9/L, normal marrow differential with <5% blasts, and RBC/platelet transfusion independent with no extramedullary leukemia. CRp: achieved CR except incomplete platelet recovery (<100x 0^9/L). CRi: criteria for CR fulfilled except incomplete hematological recovery with residual neutropenia <1x10^9/L with /without complete platelet recovery. PR: BM regenerating normal hematopoietic cells, peripheral recovery, no circulating blasts and decrease of 50% blasts in with total blasts between 5% -25% or, 5% if Auer rods present. | From the date of first response until the date of documented relapse for participants who achieved CRc or PR (median time of follow-up was 17.8 months) |
| Percentage of Participants With Composite Complete Remission (CRc Rate) | CRc rate: Number of participants with best response of CRc (CR,complete remission with incomplete platelet recovery [CRp] or complete remission with incomplete hematologic recovery [CRi]) divided by number of participants in the analysis population. CRc : Participants who achieved CR, CRp or CRi at a post-baseline visit. CR: Participants having bone marrow regenerating normal hematopoietic cells, a morphologic leukemia-free state, an ANC ≥ 1 x 10^9/L and platelet count ≥ 100 x 10^9/L, normal marrow differential with < 5% blasts, and being RBC and platelet transfusion independent with no evidence of extramedullary leukemia at a post-baseline visit. CRp: Participants achieving CR except for incomplete platelet recovery (< 100 x 10^9/L) at a post-baseline visit. CRi : Participants, who fulfilled all criteria for CR except incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery at a post-baseline visit. | From the date of randomization up to at least 6 months |
| Percentage of Participants Who Underwent Hematopoietic Stem Cell Transplant | Transplantation rate is defined as the percentage of participants undergoing Hematopoietic stem cell transplant (HSCT) during the study period. | From the date of randomization until end of study (median time of follow-up was 17.8 months) |
| Change From Baseline in Brief Fatigue Inventory (BFI) | The Brief Fatigue Inventory (BFI) was a screening tool designed to assess the severity and impact of fatigue on daily functioning of participants with cancer during the 24 hours. There are 9 items on the scale. The first three questions asked participants to rate their fatigues on a scale from 0 (no fatigue) - 10 (as bad as you can imagine), with higher scores indicating worse outcome. The remaining six questions asked participants to rate how much fatigue has interfered with their daily activities on a scale from 0 (Does not interfere) to 10 (Completely interferes). A global fatigue score can be obtained by averaging all the items on the BFI. The total score range is 0-10 with a higher BFI fatigue score indicates worse outcome. The global BFI score was calculated only if at least 5 of the 9 items are answered. | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 |
| Percentage of Participants With Complete Remission (CR) With Partial Hematological Recovery (CRh) | CRh rate was defined as the number of participants who achieved CRh at any of the postbaseline visits and did not have a best response of CR divided by the number of participants in the analysis population. CR: For participants to be classified as being in CR at a post-baseline visit, they must have had bone marrow regenerating normal hematopoietic cells and achieved a morphologic leukemia-free state and must had an ANC ≥ 1 x 10^9/L and platelet count ≥ 100 x 10^9/L and normal marrow differential with < 5% blasts, and they were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There was no evidence of extramedullary leukemia. CRh: At a post baseline visit, participantss were classified as CRh if they had marrow blasts < 5%, partial hematologic recovery ANC ≥ 0.5 x 10^9/L and platelets ≥ 50 x 10^9/L, no evidence of extramedullary leukemia and could not be classified as CR. | From the date of randomization up to at least 6 months |
| Percentage of Participants Who Achieved Transfusion Conversion and Maintenance | Transfusion conversion & maintenance rate was defined for gilteritinib arm. Participants were classified as transfusion independent if there were no RBC or platelet transfusions within 28 days prior to the first dose to 28 days after the first dose; otherwise they were classified as transfusion dependent at baseline. Participants were considered independent postbaseline if they had 1 consecutive 8 week period without any RBC or platelet transfusion from 29 days after the first dose until the last dose date. For participants who were on treatment ≤ 4 weeks or > 4 weeks but < 12 weeks and there was no RBC or platelet transfusion within postbaseline period, they were considered not evaluable; otherwise, they were considered postbaseline transfusion dependent. Transfusion conversion rate was defined for participants who had evaluable postbaseline transfusion status. Transfusion status (independent vs. dependent) at baseline and postbaseline was reported in a 2 by 2 contingency table. | From 29 days post first dose of study drug until last dose(median treatment duration was (126.00 [4.0, 885.0]) |
| Number of Participants With Treatment Emergent Adverse Events | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study drug, whether or not related to it. It could be any unfavorable/unintended sign (including abnormal laboratory finding), symptom, or disease (new/exacerbated) temporally associated with use of the study drug. A treatment-emergent adverse event (TEAE) : AEs observed after starting administration of study drug (gilteritinib or salvage chemotherapy). Serious AEs (SAEs): AEs which caused death, were life-threatening, resulted in persistent/significant disability/incapacity or disruption of the ability to conduct normal life functions, congenital anomaly, birth defect, required inpatient hospitalization/led to prolongation of hospitalization. Based on national cancer institute common terminology criteria (NCI-CTCAE), AEs were graded as grade 1=mild, grade 2=moderate, grade 3 =severe or medically significant, grade 4 =life threatening, grade 5 =death related to AE | From first dose of study drug up to 30 days after the last dose of study drug (median treatment duration for gilteritinib was (126.00 [4.0, 885.0]) days versus salvage chemotherapy 28.0 [5.0, 217.0] days) |
| Los Angeles |
| California |
| 90095-1752 |
| United States |
| Site US10076 | Orange | California | 92868 | United States |
| Site US10073 | San Francisco | California | 94143 | United States |
| Site US10067 | New Haven | Connecticut | 06504 | United States |
| Site US10045 | Gainesville | Florida | 32610 | United States |
| Site US10081 | Atlanta | Georgia | 30342 | United States |
| Site US10006 | Chicago | Illinois | 60637 | United States |
| Site US10075 | Westwood | Kansas | 66205 | United States |
| Site US10074 | Louisville | Kentucky | 40202 | United States |
| Site US10048 | New Orleans | Louisiana | 70112 | United States |
| Site US10005 | Baltimore | Maryland | 21201 | United States |
| Site US10034 | Boston | Massachusetts | 02114 | United States |
| Site US10022 | Boston | Massachusetts | 02215 | United States |
| Site US10085 | Boston | Massachusetts | 02215 | United States |
| Site US10087 | Detroit | Michigan | 48201 | United States |
| Site US10057 | Minneapolis | Minnesota | 55455 | United States |
| Site US10023 | Lebanon | New Hampshire | 03756-1000 | United States |
| Site US10027 | Hackensack | New Jersey | 07601 | United States |
| Site US10077 | New Brunswick | New Jersey | 08903 | United States |
| Site US10001 | Buffalo | New York | 14263 | United States |
| Site US10037 | New York | New York | 10029 | United States |
| Site US10008 | New York | New York | 10032 | United States |
| Site US10013 | New York | New York | 10065 | United States |
| Site US10072 | New York | New York | 10065 | United States |
| Site US10046 | Syracuse | New York | 13210 | United States |
| Site US10024 | Durham | North Carolina | 27710 | United States |
| Site US10078 | Winston-Salem | North Carolina | 27157 | United States |
| Site US10044 | Cleveland | Ohio | 44106 | United States |
| Site US10084 | Columbus | Ohio | 43210 | United States |
| Site US10058 | Oklahoma City | Oklahoma | 73104 | United States |
| Site US10041 | Hershey | Pennsylvania | 17033 | United States |
| Site US10010 | Philadelphia | Pennsylvania | 19104 | United States |
| Site US10080 | Philadelphia | Pennsylvania | 19107 | United States |
| Site US10014 | Charleston | South Carolina | 29425 | United States |
| Site US10063 | Nashville | Tennessee | 37232-0656 | United States |
| Site US10035 | Milwaukee | Wisconsin | 53226 | United States |
| Site BE32002 | Yvoir | 5530 | Belgium |
| Site CA15004 | Edmonton | Alberta | T6G 2G3 | Canada |
| Site CA15001 | Hamilton | Ontario | L8V 1C3 | Canada |
| Site CA15015 | Toronto | Ontario | M5G 2M9 | Canada |
| Site CA15003 | Montreal | Quebec | H1T 2M4 | Canada |
| Site FR33013 | Brest | 29609 | France |
| Site FR33002 | Le Chesnay | 78157 | France |
| Site FR33010 | Lille | 59037 | France |
| Site FR33009 | Pessac | 33604 | France |
| Site FR33014 | Rennes | 35033 | France |
| Site FR33008 | Toulouse | 31059 | France |
| Site DE49009 | Dresden | 01307 | Germany |
| Site DE49011 | Leipzig | 04103 | Germany |
| Site DE49003 | Marburg | 35043 | Germany |
| Site DE49002 | München | 81737 | Germany |
| Site DE49010 | Tübingen | 72076 | Germany |
| Site IL97201 | Ashkelon | 78278 | Israel |
| Site IL97209 | Haifa | 31096 | Israel |
| Site IL97203 | Jerusalem | 91031 | Israel |
| Site IL97210 | Jerusalem | 91120 | Israel |
| Site IL97206 | Petah Tikva | 49100 | Israel |
| Site IL97208 | Rehovot | 76100 | Israel |
| Site IT39005 | Bologna | 40138 | Italy |
| Site IT39010 | Brescia | 25126 | Italy |
| Site IT39001 | Milan | 20132 | Italy |
| Site IT39004 | Palermo | 90146 | Italy |
| Site IT39011 | Pavia | 27100 | Italy |
| Site IT39007 | Roma | 00189 | Italy |
| Site IT39002 | Varese | 21100 | Italy |
| Site JP81002 | Nagoya | Aichi-ken | Japan |
| Site JP81010 | Narita | Chiba | Japan |
| Site JP81026 | Yoshida-gun | Fukui | Japan |
| Site JP81016 | Sapporo | Hokkaido | Japan |
| Site JP81018 | Kobe | Hyōgo | Japan |
| Site JP81017 | Tsukuba | Ibaraki | Japan |
| Site JP81009 | Isehara | Kanagawa | Japan |
| Site JP81006 | Yokohama | Kanagawa | Japan |
| Site JP81012 | Sendai | Miyagi | Japan |
| Site JP81007 | Kurashiki | Okayama-ken | Japan |
| Site JP81014 | Sayama | Osaka | Japan |
| Site JP81020 | Kawagoe | Saitama | Japan |
| Site JP81027 | Shimotsuke | Tochigi | Japan |
| Site JP81005 | Chuo-ku | Tokyo | Japan |
| Site JP81004 | Shinagawa-ku | Tokyo | Japan |
| Site JP81022 | Shinjuku-ku | Tokyo | Japan |
| Site JP81023 | Akita | Japan |
| Site JP81021 | Aomori | Japan |
| Site JP81013 | Kumamoto | Japan |
| Site JP81025 | Kyoto | Japan |
| Site JP81008 | Nagasaki | Japan |
| Site JP81024 | Okayama | Japan |
| Site JP81011 | Osaka | Japan |
| Site PL48002 | Gdansk | 80-952 | Poland |
| Site PL48005 | Opole | 45-372 | Poland |
| Site PL48004 | Wroclaw | 50-367 | Poland |
| Site KR82005 | Suwon | Gyeonggi-do | 443380 | South Korea |
| Site KR82010 | Busan | 602739 | South Korea |
| Site KR82009 | Goyang | 602-715 | South Korea |
| Site KR82003 | Jeollanam-do | 519-809 | South Korea |
| Site KR82007 | Seoul | 110-744 | South Korea |
| Site KR82004 | Seoul | 120-752 | South Korea |
| Site KR82001 | Seoul | 135710 | South Korea |
| Site KR82002 | Seoul | 137701 | South Korea |
| Site KR82008 | Seoul | 138-736 | South Korea |
| Site KR82011 | Seoul | 156-707 | South Korea |
| Site ES34009 | Badalona | 08025 | Spain |
| Site ES34011 | Barcelona | 08035 | Spain |
| Site ES34012 | Barcelona | 08036 | Spain |
| Site ES34010 | Barcelona | 08916 | Spain |
| Site ES34016 | Girona | 17007 | Spain |
| Site ES34005 | L'Hospitalet de Llobregat | 08907 | Spain |
| Site ES34014 | Salamanca | 37007 | Spain |
| Site ES34017 | Valencia | 46026 | Spain |
| Site TW88606 | Kaohsiung City | 112 | Taiwan |
| Site TW88604 | Kaohsiung City | 83301 | Taiwan |
| Site TW88608 | Taichung | 404 | Taiwan |
| Site TW88609 | Taichung | 40705 | Taiwan |
| Site TW88601 | Tainan | 704 | Taiwan |
| Site TW88603 | Taipei | 10002 | Taiwan |
| Site TW88610 | Taipei | 10449 | Taiwan |
| Site TW88611 | Taipei | 112 | Taiwan |
| Site TW88602 | Taipei | 114 | Taiwan |
| Site TW88605 | Taoyuan | 33305 | Taiwan |
| Site TR90001 | Ankara | 06100 | Turkey (Türkiye) |
| Site TR90004 | Ankara | 06500 | Turkey (Türkiye) |
| Site GB44014 | Bournemouth | BH7 7DW | United Kingdom |
| Site GB44013 | Harrow | HA1 3UJ | United Kingdom |
| Site GB44003 | Manchester | M13 9WL | United Kingdom |
| Site GB44015 | Plymouth | PL6 8DH | United Kingdom |
| Smith CC, Levis MJ, Perl AE, Hill JE, Rosales M, Bahceci E. Molecular profile of FLT3-mutated relapsed/refractory patients with AML in the phase 3 ADMIRAL study of gilteritinib. Blood Adv. 2022 Apr 12;6(7):2144-2155. doi: 10.1182/bloodadvances.2021006489. |
| 35081255 | Derived | Perl AE, Larson RA, Podoltsev NA, Strickland S, Wang ES, Atallah E, Schiller GJ, Martinelli G, Neubauer A, Sierra J, Montesinos P, Recher C, Yoon SS, Hosono N, Onozawa M, Chiba S, Kim HJ, Hasabou N, Lu Q, Tiu R, Levis MJ. Follow-up of patients with R/R FLT3-mutation-positive AML treated with gilteritinib in the phase 3 ADMIRAL trial. Blood. 2022 Jun 9;139(23):3366-3375. doi: 10.1182/blood.2021011583. |
| 31665578 | Derived | Perl AE, Martinelli G, Cortes JE, Neubauer A, Berman E, Paolini S, Montesinos P, Baer MR, Larson RA, Ustun C, Fabbiano F, Erba HP, Di Stasi A, Stuart R, Olin R, Kasner M, Ciceri F, Chou WC, Podoltsev N, Recher C, Yokoyama H, Hosono N, Yoon SS, Lee JH, Pardee T, Fathi AT, Liu C, Hasabou N, Liu X, Bahceci E, Levis MJ. Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML. N Engl J Med. 2019 Oct 31;381(18):1728-1740. doi: 10.1056/NEJMoa1902688. |
| Link to plain language summary of the study on the Trial Results Summaries website | View source |
| FG001 | Salvage Chemotherapy | Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment 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). |
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| COMPLETED |
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| NOT COMPLETED |
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| Long Term Follow up: up to 3 Years |
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The analysis population was the Intention to Treatment (ITT), which consisted of all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gilteritinib | Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment. |
| BG001 | Salvage Chemotherapy | Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Ethnicity | Count of Participants | Participants |
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| Cytogenic Risk Status | The category of "Other" includes those with cytogenetic risk status that cannot be categorized as favorable, intermediate or unfavorable. | Count of Participants | Participants |
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| Baseline Eastern Cooperative Oncology Group (ECOG) | ECOG performance status is a scale used to assess impact on daily activities. It is based on the investigator assessment. Scores range from 0 to 5, with 0-signifying fully active participant; 1-restricted in physically strenuous activity; 2-ambulatory and capable of all self-care, unable to work; 3-capable of only limited self-care, confined to bed more than 50% of waking hours; 4-completely disabled and 5-dead. Negative numerical score indicates an improvement and positive numerical score indicates a decline in participant's daily activities, indicating disease progression. | Count of Participants | Participants |
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| FLT3 Mutation Status by Central Testing by FLT3 CDx | Count of Participants | Participants |
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| Prior Use of FLT3 Inhibitor | Prior use of FLT3 inhibitor is defined as 'Yes' if participants received prior AML therapy of midostaurin, sorafenib or quizartinib; otherwise, prior use of FLT3 inhibitor is assigned as No. | Count of Participants | Participants |
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| Region | Count of Participants | Participants |
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| Baseline Body Surface Area (BSA) | The analysis population was the ITT, with available data. | Mean | Standard Deviation | m^2 |
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| Baseline Height | The analysis population was the ITT, with available data. | Mean | Standard Deviation | centimeter (cm) |
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| Baseline Weight | The analysis population was the ITT, with available data. | Mean | Standard Deviation | kilogram (kg) |
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| Response to First Line Therapy | Baseline stratification factors. | Count of Participants | Participants |
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| Preselected Salvage Chemotherapy | Baseline stratification factors. | Count of Participants | Participants |
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| Response to First Line Therapy-Preselected Salvage Chemotherapy | Baseline stratification factors. HSCT is hematopoietic stem cell transplant. CRc is composite complete remission. | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Duration of Overall Survival (OS) | Overall survival was defined as the time from the date of randomization until the date of death from any cause (death date - randomization date + 1). 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 (date of last contact - randomized date + 1). The date of last contact was the latest date that the participant was known to be alive. The last contact date was derived for participants alive at the analysis cutoff date. Survival rate and 95% CI were estimated using the Kaplan-Meier method and the Greenwood formula. | The analysis population was the Intention to Treatment (ITT) which consisted of all randomized participants. | Posted | Median | 95% Confidence Interval | Months | From randomization to until the date of death from any cause (median time of follow-up for OS was 17.8 months) |
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| Primary | Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm | The CR/CRh rate was defined as the number of participants who achieved either CR or CRh divided by the number of participants in the analysis population. CR: For participants to be classified as being in CR at, they must have had bone marrow regenerating normal hematopoietic cells and achieved a morphologic leukemia-free state and must had an ANC ≥ 1 x 10^9/L and platelet count ≥ 100 x 10^9/L and normal marrow differential with < 5% blasts, and they were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There was no evidence of extramedullary leukemia. CRh: Participants were classified as CRh if they had marrow blasts < 5%, partial hematologic recovery ANC ≥ 0.5 x 10^9/L and platelets ≥ 50 x 10^9/L, no evidence of extramedullary leukemia and could not be classified as CR. | The analysis population was the response analysis set (RAS) which consisted of participants who were who were at least 112 days past the first dose of gilteritinib or randomization (for participants who did not receive gilteritinib). The participants were analyzed based on the randomized treatments. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of randomization up to at least 112 days |
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| Secondary | Duration of Event-Free Survival (EFS) | EFS: time from randomization date up to date of documented relapse (excluding relapse after PR)/ treatment failure (failure to achieve CR, CRp, CRi /PR) /death, whichever occurred first. Relapse: leukemic blasts in peripheral blood 5/ ≥ 25% blasts in bone marrow (BM) aspirate due to no other cause/reappearance/new appearance of extramedullary leukemia. CR: BM regenerating normal hematopoietic cells, morphologic leukemia-free state, ANC ≥1x10^9/L, platelet count ≥100x10^9/L, normal marrow differential with <5% blasts, and RBC/platelet transfusion independent with no extramedullary leukemia. CRp: achieved CR except incomplete platelet recovery (<100x 0^9/L). CRi: criteria for CR fulfilled except incomplete hematological recovery with residual neutropenia <1x10^9/L with /without complete platelet recovery. PR: BM regenerating normal hematopoietic cells, peripheral recovery, no circulating blasts and decrease of 50% blasts in with total blasts between 5% -25% or, 5% if Auer rods present. | The analysis population was the ITT with available data. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization until the date of documented relapse, treatment failure or death from any cause (median time of follow-up was 17.8 months) |
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| Secondary | Percentage of Participants With Complete Remission (CR) Rate | The CR rate was defined as the number of participants who achieved the best response of CR divided by the number of participants in the analysis population. CR: For participants to be classified as being in CR, they must have had bone marrow regenerating normal hematopoietic cells and achieved a morphologic leukemia-free state and must had an ANC ≥ 1 x 10^9/L and platelet count ≥ 100 x 10^9/L and normal marrow differential with < 5% blasts, and they were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There was no evidence of extramedullary leukemia. | The analysis population was the ITT. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of randomization up to at least 6 months |
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| Secondary | Duration of Leukemia-Free Survival (LFS) | LFS: time from the date of first CRc until the date of documented relapse or death for subjects who achieve CRc. For a subject who is not known to have relapsed or died, LFS is censored on the date of last relapse-free disease assessment date. CRc: achieved CR, CRp or CRi. Relapse: leukemic blasts in peripheral blood/ ≥ 25% blasts in bone marrow (BM) aspirate not due to any other cause/reappearance/new appearance of extramedullary leukemia. CR: BM regenerating normal hematopoietic cells, morphologic leukemia-free state, ANC ≥ 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, normal marrow differential with < 5% blasts, and RBC/platelet transfusion independent with no extramedullary leukemia. CRp: achieved CR except incomplete platelet recovery (< 100 x 10^9/L). CRi : criteria for CR fulfilled except incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with /without complete platelet recovery.. | The analysis population was the ITT, with participants with best response of CRc. | Posted | Median | 95% Confidence Interval | Months | From the date of first CRc until the date of documented relapse or death for participants who achieved CRc (median time of follow-up was 17.8 months) |
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| Secondary | Duration of Remission | Duration of remission included duration of CRc, CR/CRh, CRh, CR, CRi, CRp (defined as the time from the date of first CRc until the date of first documented relapse for participants who achieved CRc, CR/CRh, CRh, CR, CRi, CRp respectively) and duration of response (CRc + PR). CRc: achieved CR, CRp or CRi at the visit. CR: BM regenerating normal hematopoietic cells, morphologic leukemia-free state, ANC ≥1x10^9/L, platelet count ≥100x10^9/L, normal marrow differential with <5% blasts, and RBC/platelet transfusion independent with no extramedullary leukemia. CRp: achieved CR except incomplete platelet recovery (<100x 0^9/L). CRi: criteria for CR fulfilled except incomplete hematological recovery with residual neutropenia <1x10^9/L with /without complete platelet recovery. PR: BM regenerating normal hematopoietic cells, peripheral recovery, no circulating blasts and decrease of 50% blasts in with total blasts between 5% -25% or, 5% if Auer rods present. | The analysis population was the ITT, Duration of CR was only applicable to participants with best overall response of CR. | Posted | Median | 95% Confidence Interval | Months | From the date of first response until the date of documented relapse for participants who achieved CRc or PR (median time of follow-up was 17.8 months) |
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| Secondary | Percentage of Participants With Composite Complete Remission (CRc Rate) | CRc rate: Number of participants with best response of CRc (CR,complete remission with incomplete platelet recovery [CRp] or complete remission with incomplete hematologic recovery [CRi]) divided by number of participants in the analysis population. CRc : Participants who achieved CR, CRp or CRi at a post-baseline visit. CR: Participants having bone marrow regenerating normal hematopoietic cells, a morphologic leukemia-free state, an ANC ≥ 1 x 10^9/L and platelet count ≥ 100 x 10^9/L, normal marrow differential with < 5% blasts, and being RBC and platelet transfusion independent with no evidence of extramedullary leukemia at a post-baseline visit. CRp: Participants achieving CR except for incomplete platelet recovery (< 100 x 10^9/L) at a post-baseline visit. CRi : Participants, who fulfilled all criteria for CR except incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery at a post-baseline visit. | The analysis population was the ITT. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of randomization up to at least 6 months |
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| Secondary | Percentage of Participants Who Underwent Hematopoietic Stem Cell Transplant | Transplantation rate is defined as the percentage of participants undergoing Hematopoietic stem cell transplant (HSCT) during the study period. | The analysis population is the ITT. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of randomization until end of study (median time of follow-up was 17.8 months) |
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| Secondary | Change From Baseline in Brief Fatigue Inventory (BFI) | The Brief Fatigue Inventory (BFI) was a screening tool designed to assess the severity and impact of fatigue on daily functioning of participants with cancer during the 24 hours. There are 9 items on the scale. The first three questions asked participants to rate their fatigues on a scale from 0 (no fatigue) - 10 (as bad as you can imagine), with higher scores indicating worse outcome. The remaining six questions asked participants to rate how much fatigue has interfered with their daily activities on a scale from 0 (Does not interfere) to 10 (Completely interferes). A global fatigue score can be obtained by averaging all the items on the BFI. The total score range is 0-10 with a higher BFI fatigue score indicates worse outcome. The global BFI score was calculated only if at least 5 of the 9 items are answered. | The analysis population was the ITT, with participants with data at baseline. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 |
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| Secondary | Percentage of Participants With Complete Remission (CR) With Partial Hematological Recovery (CRh) | CRh rate was defined as the number of participants who achieved CRh at any of the postbaseline visits and did not have a best response of CR divided by the number of participants in the analysis population. CR: For participants to be classified as being in CR at a post-baseline visit, they must have had bone marrow regenerating normal hematopoietic cells and achieved a morphologic leukemia-free state and must had an ANC ≥ 1 x 10^9/L and platelet count ≥ 100 x 10^9/L and normal marrow differential with < 5% blasts, and they were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There was no evidence of extramedullary leukemia. CRh: At a post baseline visit, participantss were classified as CRh if they had marrow blasts < 5%, partial hematologic recovery ANC ≥ 0.5 x 10^9/L and platelets ≥ 50 x 10^9/L, no evidence of extramedullary leukemia and could not be classified as CR. | The analysis population was the ITT. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of randomization up to at least 6 months |
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| Secondary | Percentage of Participants Who Achieved Transfusion Conversion and Maintenance | Transfusion conversion & maintenance rate was defined for gilteritinib arm. Participants were classified as transfusion independent if there were no RBC or platelet transfusions within 28 days prior to the first dose to 28 days after the first dose; otherwise they were classified as transfusion dependent at baseline. Participants were considered independent postbaseline if they had 1 consecutive 8 week period without any RBC or platelet transfusion from 29 days after the first dose until the last dose date. For participants who were on treatment ≤ 4 weeks or > 4 weeks but < 12 weeks and there was no RBC or platelet transfusion within postbaseline period, they were considered not evaluable; otherwise, they were considered postbaseline transfusion dependent. Transfusion conversion rate was defined for participants who had evaluable postbaseline transfusion status. Transfusion status (independent vs. dependent) at baseline and postbaseline was reported in a 2 by 2 contingency table. | The analysis population was the ITT, with participants who had evaluable postbaseline transfusion status. | Posted | Number | Percentage of participants | From 29 days post first dose of study drug until last dose(median treatment duration was (126.00 [4.0, 885.0]) |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study drug, whether or not related to it. It could be any unfavorable/unintended sign (including abnormal laboratory finding), symptom, or disease (new/exacerbated) temporally associated with use of the study drug. A treatment-emergent adverse event (TEAE) : AEs observed after starting administration of study drug (gilteritinib or salvage chemotherapy). Serious AEs (SAEs): AEs which caused death, were life-threatening, resulted in persistent/significant disability/incapacity or disruption of the ability to conduct normal life functions, congenital anomaly, birth defect, required inpatient hospitalization/led to prolongation of hospitalization. Based on national cancer institute common terminology criteria (NCI-CTCAE), AEs were graded as grade 1=mild, grade 2=moderate, grade 3 =severe or medically significant, grade 4 =life threatening, grade 5 =death related to AE | The analysis population was the safety analysis set (SAF), which consisted of participants who received who received at least 1 dose of study drug (gilteritinib or salvage chemotherapy). | Posted | Count of Participants | Participants | From first dose of study drug up to 30 days after the last dose of study drug (median treatment duration for gilteritinib was (126.00 [4.0, 885.0]) days versus salvage chemotherapy 28.0 [5.0, 217.0] days) |
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Adverse events: From first dose of study drug up to 30 days after the last dose of study drug (median treatment duration for gilteritinib was (126.00 [4.0, 885.0]) days versus salvage chemotherapy 28.0 [5.0, 217.0] days) All cause mortality: From randomization up to end of study (approximately 112 months)
Adverse events: The SAF consisted of all participants who received at least dose of study treatment (gilteritinib or salvage chemotherapy).
All cause mortality: All randomised participants.
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 | Gilteritinib | Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment. | 204 | 247 | 211 | 246 | 242 | 246 |
| EG001 | Salvage Chemotherapy | Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment 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). | 96 | 124 | 34 | 109 | 103 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
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| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
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| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
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| Bone marrow failure | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
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| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
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| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA v23 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA v23 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA v23 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA v23 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA v23 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA v23 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA v23 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA v23 | Systematic Assessment |
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| Myocarditis | Cardiac disorders | MedDRA v23 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA v23 | Systematic Assessment |
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| Pericardial haemorrhage | Cardiac disorders | MedDRA v23 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA v23 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA v23 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA v23 | Systematic Assessment |
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| Accessory breast | Congenital, familial and genetic disorders | MedDRA v23 | Systematic Assessment |
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| Hamartoma | Congenital, familial and genetic disorders | MedDRA v23 | Systematic Assessment |
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| Deafness bilateral | Ear and labyrinth disorders | MedDRA v23 | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA v23 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA v23 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Anal fissure | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Duodenal perforation | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Intestinal ischaemia | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Mouth haemorrhage | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Stomatitis necrotising | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Tongue haematoma | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA v23 | Systematic Assessment |
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| Chills | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Death | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Mucosal haemorrhage | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA v23 | Systematic Assessment |
| |
| Acute graft versus host disease in intestine | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Graft versus host disease in gastrointestinal tract | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Abscess bacterial | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Adenoviral upper respiratory infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Bacterial colitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Cellulitis | 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 |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Epstein-Barr viraemia | 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 sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Eye infection bacterial | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Eye infection toxoplasmal | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Hepatic infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Leptotrichia infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Lower respiratory tract infection fungal | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Oesophageal infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Periorbital infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumococcal sepsis | 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 respiratory syncytial viral | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia viral | 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 |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Respiratory tract infection fungal | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Scrotal infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Systemic bacterial infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Systemic mycosis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Tooth infection | 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 |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Vulval cellulitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Anaphylactic transfusion reaction | Injury, poisoning and procedural complications | 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 |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA v23 | Systematic Assessment |
| |
| Toxicity to various agents | 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 fibrinogen decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Blood pressure decreased | 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 |
| |
| General physical condition abnormal | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Menstruation normal | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Norovirus test positive | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| White blood cell count increased | 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 |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyperphosphataemia | 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 |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hyponatraemic syndrome | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v23 | Systematic Assessment |
| |
| Metabolic acidosis | 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 |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Soft tissue necrosis | 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 |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Cancer pain | 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 |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Leukaemia cutis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Soft tissue sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Cerebellar haemorrhage | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Mental status changes | 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 |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v23 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA v23 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v23 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | 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 |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Obliterative bronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Organising pneumonia | 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 |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Pulmonary artery thrombosis | 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 |
| |
| Pulmonary hypertension | 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 |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Haemorrhage | 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 |
| |
| Venous thrombosis | Vascular 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 |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v23 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v23 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA v23 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v23 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Nausea | 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 |
| |
| Chills | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Fatigue | 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 |
| |
| Pyrexia | General disorders | MedDRA v23 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA v23 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v23 | Systematic Assessment |
| |
| Upper respiratory tract infection | 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 |
| |
| 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 lactate dehydrogenase increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v23 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v23 | Systematic Assessment |
| |
| Weight increased | 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 |
| |
| 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 |
| |
| 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 |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Muscular weakness | 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 |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v23 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v23 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v23 | Systematic Assessment |
| |
| Haematuria | Renal and urinary 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 |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v23 | Systematic Assessment |
| |
| Epistaxis | 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 |
| |
| Productive cough | Respiratory, thoracic and mediastinal 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 |
| |
| 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 |
| |
| Hypertension | Vascular disorders | MedDRA v23 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v23 | Systematic Assessment |
|
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 Trial Disclosure | Astellas Pharma Global Development, Inc. | 800-888-7704 | astellas.resultsdisclosure@astellas.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2022 | Aug 11, 2025 | SAP_003.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 |
| D003561 | Cytarabine |
| D001374 | Azacitidine |
| D008942 | Mitoxantrone |
| D005047 | Etoposide |
| D016179 | Granulocyte Colony-Stimulating Factor |
| C024352 | fludarabine |
| D015255 | Idarubicin |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D012263 | Ribonucleosides |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
Not provided
Not provided
| Death |
|
| Miscellaneous |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Relapse within 6 months after CRc and no HSCT |
|
|
| Relapse after 6 months after CRc and no HSCT |
|
|
| Relapse within 6 months after allogeneic HSCT |
|
|
| Relapse after 6 months after allogeneic HSCT |
|
|
|
| Low intensity chemotherapy |
|
|
|
| Primary refractory w/o HSCT, low IT |
|
|
| Relapse w/I 6 mths after CRc and no HSCT, high IT |
|
|
| Relapse w/I 6 mths after CRc and no HSCT low IT |
|
|
| Relapse after 6 mths after CRc and no HSCT high IT |
|
|
| Relapse w/I 6 mths after allogeneic HSCT low IT |
|
|
| Relapse w/I 6 mths after allogeneic HSCT high IT |
|
|
| Relapse after 6 mths after allogeneic HSCT high IT |
|
|
| Relapse after 6 mths after CRc and no HSCT low IT |
|
|
| Relapse after 6 mths after allogeneic HSCT low IT |
|
|
|
|
| OG001 | Salvage Chemotherapy | Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment 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). |
|
|
|
| OG001 | Salvage Chemotherapy | Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment 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). |
|
|
|
| OG001 | Salvage Chemotherapy | Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment 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). |
|
|
|
| OG001 | Salvage Chemotherapy | Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment 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). |
|
|
|
| OG001 | Salvage Chemotherapy | Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment 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). |
|
|
|
|
|
|
| OG001 | Salvage Chemotherapy | Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment 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). |
|
|
|
| OG001 | Salvage Chemotherapy | Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment 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). |
|
|
|
|
|
| OG001 | Salvage Chemotherapy | Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment 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). |
|
|