Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-05-30 @ 1:09 AM
Study NCT ID:
NCT02752035
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2016-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609080', 'term': 'gilteritinib'}, {'id': 'D001374', 'term': 'Azacitidine'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astellas.resultsdisclosure@astellas.com', 'phone': '800-888-7704', 'title': 'Clinical Transparency', 'organization': 'Astellas Pharma Global Development, Inc.'}, 'certainAgreement': {'otherDetails': "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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Protocol versions 6.0 and earlier included a 1:1:1 randomization ratio to receive Gilteritinib + AZA, AZA-only and Gilteritinib-only. Randomization to arm Gilteritinib-only was removed in protocol version 7.0. Participants previously randomized to Gilteritinib-only arm continued following treatment and assessments as outlined in the protocol.'}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality (ACM): From randomization up to end of study duration (101 months) AEs: From first dose up to end of study duration (101 months)', 'description': 'ACM: All randomized participants.\n\nAEs: SAF consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).', 'eventGroups': [{'id': 'EG000', 'title': 'Safety Cohort: Gilteritinib + Azacitidine (AZA)', 'description': 'Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 14, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 89, 'otherNumAffected': 87, 'seriousNumAtRisk': 88, 'deathsNumAffected': 70, 'seriousNumAffected': 81}, {'id': 'EG002', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 57, 'otherNumAffected': 46, 'seriousNumAtRisk': 54, 'deathsNumAffected': 49, 'seriousNumAffected': 34}, {'id': 'EG003', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 22, 'seriousNumAtRisk': 22, 'deathsNumAffected': 22, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 59, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 30, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 23, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 104, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 35, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 22, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 63, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 11, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Cardiac dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Meibomian gland dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Anal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 52, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 53, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 55, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 38, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 37, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Catheter site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Neutrophilic dermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG001', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG002', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.82', 'groupId': 'OG000', 'lowerLimit': '8.11', 'upperLimit': '13.17'}, {'value': '9.23', 'groupId': 'OG001', 'lowerLimit': '4.34', 'upperLimit': '12.55'}, {'value': '5.24', 'groupId': 'OG002', 'lowerLimit': '2.46', 'upperLimit': '15.18'}]}]}], 'analyses': [{'pValue': '0.523', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.870', 'ciLowerLimit': '0.570', 'ciUpperLimit': '1.329', 'estimateComment': 'Based on Cox proportional hazards model.', 'groupDescription': 'Stratification factors were age group per IRT, risk groups and baseline FLT3 mutation status, with potential of strata pooling.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until the date of death from any cause ( maximum duration up to 79 months)', 'description': 'OS was defined as the time from the date of randomization until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact. Kaplan-Meier (KM) estimates was used for analysis.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) was defined as the intention to treat set, which consisted of participants who were randomized and were used for efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG001', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG002', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'comment': 'Lower and upper limits of the 95% confidence interval were not estimable due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.03', 'comment': 'Lower and upper limits of the 95% confidence interval were not estimable due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '2.46'}]}]}], 'analyses': [{'pValue': '0.787', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.940', 'ciLowerLimit': '0.635', 'ciUpperLimit': '1.393', 'estimateComment': 'Based on Cox proportional hazards model.', 'groupDescription': 'Stratification factors were age group per IRT, risk groups and baseline FLT3 mutation status, with potential of strata pooling.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until the date of documented relapse from CR, treatment failure or death from any cause, whichever occurred first (up to 39.7 months)', 'description': 'EFS: time from the date of randomization until the date of documented relapse from Complete Remission (CR), treatment failure(failing to achieve CR within 6 cycles of treatment) or death from any cause, whichever occurred first. CR: bone marrow(BM) regenerating normal hematopoietic cells, morphologically leukemia-free state, absolute neutrophil count (ANC) ≥1 × 10\\^9/L, platelet count ≥100 × 10\\^9/L, normal marrow differential with \\<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being red blood cell (RBC) and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. Relapse: reappearance of leukemic blasts \\>2% in the peripheral blood/≥ 5% myeloblasts in the BM unattributable to any other cause/new/reappearance of extramedullary leukemia.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Best Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG001', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG002', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000'}, {'value': '17.5', 'groupId': 'OG001'}, {'value': '9.1', 'groupId': 'OG002'}]}]}, {'title': 'CRp', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '18.2', 'groupId': 'OG002'}]}]}, {'title': 'CRi', 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000'}, {'value': '10.5', 'groupId': 'OG001'}, {'value': '27.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization until the date of death from any cause (up to 57 months)', 'description': 'Best response for a participant was defined as the best measured response (in the order of CR, CR with Incomplete Platelet Recovery (CRp), CR with Incomplete Hematologic Recovery (CRi), and treatment failure) from all post-baseline visits. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\\^9/L, platelet count ≥100 × 10\\^9/L, normal marrow differential with \\<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (\\< 100 × 10\\^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia \\< 1 x 10\\^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population'}, {'type': 'SECONDARY', 'title': 'Completed Remission (CR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG001', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG002', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000'}, {'value': '17.5', 'groupId': 'OG001'}, {'value': '9.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.249', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.2', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '23.0', 'pValueComment': 'Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization until the date of death from any cause (approximately 49.7 months)', 'description': 'CR rate: number of participants who achieved the best response of CR divided by the number of participants in the analysis population. Participants with unknown or missing response, or who provided no information on response at the end of treatment were included in the denominator when calculating rates. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\\^9/L, platelet count ≥100 × 10\\^9/L, normal marrow differential with \\<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent(1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population'}, {'type': 'SECONDARY', 'title': 'CRc Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG001', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG002', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'groupId': 'OG000'}, {'value': '28.1', 'groupId': 'OG001'}, {'value': '54.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.3', 'ciLowerLimit': '16.6', 'ciUpperLimit': '50.0', 'pValueComment': 'Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization until the date of death from any cause (approximately 54.5 months)', 'description': 'CRc rate was defined as participants with best response of (CR + CRp + CRi) divided by the number of participants in the analysis population. Participants were classified as: CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\\^9/L, platelet count ≥100 × 10\\^9/L, normal marrow differential with \\<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (\\< 100 × 10\\^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia \\< 1 x 10\\^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required. Percentage of participants with CRc was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population'}, {'type': 'SECONDARY', 'title': 'Complete Remission With Partial Hematologic Recovery (CRh)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG001', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG002', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '22.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.5', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '17.1', 'pValueComment': 'Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization until the date of death from any cause (up to 49.7 months)', 'description': 'CRh was defined as the response at a post baseline visit as CRh having bone marrow myeloblast count \\< 5%, partial hematologic recovery ANC ≥ 0.5 x 10\\^9/L and platelets ≥ 50 x 10\\^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood must be ≤ 2% or missing. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\\^9/L, platelet count ≥100 × 10\\^9/L, normal marrow differential with \\<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. Percentage of participants with CRh was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population'}, {'type': 'SECONDARY', 'title': 'CR/CRh Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG001', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG002', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}, {'value': '19.3', 'groupId': 'OG001'}, {'value': '31.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.7', 'ciLowerLimit': '1.1', 'ciUpperLimit': '32.4', 'pValueComment': 'Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization until the date of death from any cause (up to 49.7 months)', 'description': 'CR/CRh rate: number of participants who achieved CR or CRh divided by the number of participants in the analysis population. CR/CRh: CR/CRh if it fulfilled criteria for CR or CRh at the visit. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\\^9/L, platelet count ≥100 × 10\\^9/L, normal marrow differential with \\<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRh: response at a post baseline visit as CRh having bone marrow myeloblast count \\< 5%, partial hematologic recovery ANC ≥ 0.5 x 10\\^9/L and platelets ≥ 50 x 10\\^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood must be ≤ 2% or missing. Percentage of participants with CR/CRh was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Transfusion Conversion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG001', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG002', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.6', 'groupId': 'OG000', 'lowerLimit': '24.7', 'upperLimit': '47.7'}, {'value': '44.7', 'groupId': 'OG001', 'lowerLimit': '28.6', 'upperLimit': '61.7'}, {'value': '61.1', 'groupId': 'OG002', 'lowerLimit': '35.7', 'upperLimit': '82.7'}]}]}], 'analyses': [{'pValue': '0.340', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9', 'ciLowerLimit': '-29.8', 'ciUpperLimit': '11.0', 'pValueComment': 'Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline up to 57 months', 'description': 'Transfusion conversion rate was defined as the number of participants who were transfusion dependent at baseline period but became transfusion independent at post-baseline period divided by the total number of participants who were transfusion dependent at baseline period.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included participants who were transfusion dependent at baseline period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Transfusion Maintenance Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG001', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG002', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '100.0'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}], 'analyses': [{'pValue': '0.221', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50', 'ciLowerLimit': '-61.0', 'ciUpperLimit': '100.0', 'pValueComment': 'Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline up to 57 months', 'description': 'Transfusion maintenance rate was defined as the number of participants who were transfusion independent at baseline period and remained transfusion independent post-baseline period divided by the total number of participants who were transfusion independent at baseline period.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included participants who were transfusion independent at baseline period.'}, {'type': 'SECONDARY', 'title': 'Leukemia-free Survival (LFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG001', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG002', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.16', 'groupId': 'OG000', 'lowerLimit': '6.01', 'upperLimit': '12.52'}, {'value': '8.08', 'groupId': 'OG001', 'lowerLimit': '2.46', 'upperLimit': '14.09'}, {'value': '3.20', 'groupId': 'OG002', 'lowerLimit': '0.89', 'upperLimit': '6.87'}]}]}], 'analyses': [{'pValue': '0.592', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.844', 'ciLowerLimit': '0.451', 'ciUpperLimit': '1.580', 'estimateComment': 'Based on Cox proportional hazards model adjusting age group per IRT.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From first day of achieving first CRc to the first day of confirmed relapse/death (up to 54.5 months)', 'description': 'LFS: time from the date of first CRc (CR + CRp + CRi) until the date of documented relapse (excluding relapse from PR) or death for participants who achieved CRc. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\\^9/L, platelet count ≥100 × 10\\^9/L, normal marrow differential with \\<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (\\< 100 × 10\\^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia \\< 1 x 10\\^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required. CRc: fulfilled criteria for CR, CRp or CRi. Based on KM estimates.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included participants who had achieved CRc.'}, {'type': 'SECONDARY', 'title': 'Duration of Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG001', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG002', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'classes': [{'title': 'Duration of CR/CRh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.94', 'comment': 'Median and upper limit of confidence interval was not estimable due to an insufficient number of events to determine 50% survival.', 'groupId': 'OG000', 'lowerLimit': '6.93', 'upperLimit': 'NA'}, {'value': '8.08', 'groupId': 'OG001', 'lowerLimit': '0.95', 'upperLimit': '8.57'}, {'value': '2.83', 'groupId': 'OG002', 'lowerLimit': '1.87', 'upperLimit': '5.95'}]}]}, {'title': 'Duration of CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.10', 'comment': 'Upper limit of confidence interval was not estimable due to an insufficient number of events to determine 50% survival.', 'groupId': 'OG000', 'lowerLimit': '7.39', 'upperLimit': 'NA'}, {'value': '8.25', 'comment': 'Upper limit of confidence interval was not estimable due to an insufficient number of events to determine 50% survival.', 'groupId': 'OG001', 'lowerLimit': '0.95', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median, lower and upper limit of confidence interval was not estimable due to an insufficient number of events to determine 50% survival.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Duration of CRc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.52', 'comment': 'Upper limit of confidence interval was not estimable due to an insufficient number of events to determine 50% survival.', 'groupId': 'OG000', 'lowerLimit': '6.77', 'upperLimit': 'NA'}, {'value': '8.25', 'groupId': 'OG001', 'lowerLimit': '2.10', 'upperLimit': '14.09'}, {'value': '3.65', 'groupId': 'OG002', 'lowerLimit': '0.89', 'upperLimit': '7.39'}]}]}, {'title': 'Duration of CRh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.77', 'groupId': 'OG000', 'lowerLimit': '1.35', 'upperLimit': '6.93'}, {'value': '8.08', 'comment': 'Lower and upper limit of 95% confidence interval was not estimable due to insufficient number of participants.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.83', 'groupId': 'OG002', 'lowerLimit': '1.87', 'upperLimit': '5.95'}]}]}, {'title': 'Duration of response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.92', 'groupId': 'OG000', 'lowerLimit': '3.98', 'upperLimit': '18.40'}, {'value': '7.62', 'groupId': 'OG001', 'lowerLimit': '0.95', 'upperLimit': '9.23'}, {'value': '3.65', 'groupId': 'OG002', 'lowerLimit': '0.95', 'upperLimit': '6.87'}]}]}], 'analyses': [{'pValue': '0.300', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.573', 'ciLowerLimit': '0.198', 'ciUpperLimit': '1.658', 'estimateComment': 'Based on Cox proportional hazards model adjusting age group per IRT.', 'groupDescription': 'Analysis reported for duration of CR/CRh.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.171', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.411', 'ciLowerLimit': '0.113', 'ciUpperLimit': '1.504', 'estimateComment': 'Based on Cox proportional hazards model adjusting age group per IRT.', 'groupDescription': 'Analysis reported for duration of CR.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.383', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.691', 'ciLowerLimit': '0.295', 'ciUpperLimit': '1.620', 'estimateComment': 'Based on Cox proportional hazards model adjusting age group per IRT.', 'groupDescription': 'Analysis reported for duration of CRc', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.998', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '999', 'ciLowerLimit': '0.001', 'estimateComment': 'Based on Cox proportional hazards model adjusting age group per IRT.', 'groupDescription': 'Analysis reported for duration of CRh.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'ciUpperLimitComment': 'Upper limit of 95% confidence interval was not estimable due to insufficient number of participants.'}, {'pValue': '0.174', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.628', 'ciLowerLimit': '0.321', 'ciUpperLimit': '1.229', 'estimateComment': 'Based on Cox proportional hazards model adjusting age group per IRT.', 'groupDescription': 'Analysis reported for duration of response.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From first day of achieving first response to the first day of confirmed relapse/death (up to 56.4 months)', 'description': 'Duration of remission included CRc, CR, CRh, CR/CRh, and response duration \\[CRc + PR\\]. Duration of CRc, CR, CRh: the time from the date of first CRc until the date of first documented relapse for participants who achieved CRc, CR, and CRh, respectively. CR/CRh: fulfilled criteria for CR or CRh at the visit. CRh: marrow blasts \\<5%, ANC ≥0.5×10\\^9/L, platelets ≥50×10\\^9/L, not meeting CR criteria. PR: If marrow myeloblasts between \\<5% and 25% and ≤2% or missing peripheral blood blast and a decrease from baseline of at least 50% in the marrow myeloblasts and no evidence of extramedullary leukemia, the response was classified as PR. If marrow myeloblasts \\<5% and ≤2% or missing peripheral blood blast and no evidence of extramedullary leukemia, the response was classified as PR even with Auer rods.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with available data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Brief Fatigue Inventory (BFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG001', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG002', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '2.92', 'groupId': 'OG001'}, {'value': '1.37', 'spread': '3.49', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.560', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '2.0', 'estimateComment': 'Least square mean difference and P-value were calculated using AZA as reference.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Using analysis of covariance including treatment, age group per IRT and baseline score as covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 31 months', 'description': 'The BFI was a tool to assess fatigue severity and impact on daily function in cancer participants over 24 hours. It included 9 items. A global fatigue score was computed by averaging the scores of the 9 items measured on the numeric rating scale. Scores were calculated if ≥5 of 9 items were answered. A higher score indicates a higher degree of fatigue. The first 3 rate fatigue from 0 (no fatigue) to 10 (worst imaginable), with higher scores indicating worse outcomes. The remaining 6 assess how fatigue interferes with daily activities from 0 (no interference) to 10 (completely interferes). A global fatigue score (0-10) was the average of all items, with higher scores indicating worse fatigue. Overall BFI score is reported.', 'unitOfMeasure': 'Scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population with available data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Cohort: Gilteritinib + AZA', 'description': 'Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made.'}, {'id': 'OG001', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG002', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG003', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to end of study duration (101 months)', 'description': 'An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \\& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE was defined as an adverse event observed after starting administration of the study drug until 30 days from the last study treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drug (ASP2215 or azacitidine).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Cohort: Gilteritinib + AZA', 'description': 'Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made.'}, {'id': 'OG001', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG002', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'OG003', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'classes': [{'title': 'Baseline: Grade 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Grade 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'End of Treatment (EOT): Grade 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'EOT: Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'EOT: Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'EOT: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'EOT: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'EOT: Grade 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to end of treatment (up to 57 months)', 'description': 'ECOG performance scores at each assessment time were be provided by treatment group. Negative change scores indicated an improvement and positive scores indicate a decline in performance. The grades were defined as follows:\n\n0: Fully active, able to carry on all pre-disease performance without restriction.\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.\n2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.\n3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.\n4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.\n5. Dead.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF population with available data was analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Safety Cohort: Gilteritinib + Azacitidine (AZA)', 'description': 'Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'FG001', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'FG002', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'FG003', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}], 'periods': [{'title': 'Safety Cohort: Approximately 5 Years', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Disease relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Randomization: Approximately 3 Years', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '57'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '57'}, {'groupId': 'FG003', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Disease Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}]}]}, {'title': 'Long-term Follow-up: up to 3 Years', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants with newly diagnosed, FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML) not eligible for intensive induction were enrolled.', 'preAssignmentDetails': 'Prior to randomized cohort, participants were enrolled for safety cohort to evaluate safety and tolerability of gilteritinib given with azacitidine therapy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '183', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Safety Cohort: Gilteritinib + Azacitidine (AZA)', 'description': 'Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'BG001', 'title': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles in combination with 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion.After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'BG002', 'title': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.'}, {'id': 'BG003', 'title': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.3', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '77.1', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '76.9', 'spread': '5.2', 'groupId': 'BG002'}, {'value': '78.5', 'spread': '4.2', 'groupId': 'BG003'}, {'value': '77.1', 'spread': '5.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '153', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '106', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Data reported for Race.', 'unitOfMeasure': 'Participants'}, {'title': 'Age group per Interactive Response Technology (IRT)', 'classes': [{'title': '< 75 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '131', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'IRT is a system used in clinical trials to manage randomization, treatment allocation, and trial supply logistics.', 'unitOfMeasure': 'Participants'}, {'title': 'FMS-like tyrosine kinase 3 (FLT3) mutation type', 'classes': [{'title': 'Internal Tandem Duplication (ITD) Alone', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}]}, {'title': 'Tyrosine Kinase Domain (TKD) (D835/I836) Alone', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}, {'title': 'ITD with TKD (D835/I836)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'Others (unknown/missing/negative)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'FLT3 is a receptor tyrosine kinase that is expressed almost exclusively in the hematopoietic compartment.', 'unitOfMeasure': 'Participants'}, {'title': 'Cytogenetic risk status', 'classes': [{'title': 'Favorable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Intermediate', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '131', 'groupId': 'BG004'}]}]}, {'title': 'Unfavorable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}, {'title': 'Others (unknown, missing)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The cytogenetic risk status was categorized as Favorable \\[Core binding factor: inv(16) or t(16;16) or t(8;21). Other cytogenetic abnormalities in addition to these do not alter better risk status\\], Intermediate \\[Normal cytogenetics, +8 alone, t(9;11), Other non-defined cytogenetic abnormality\\], or Unfavorable \\[Complex (≥ 3 clonal chromosomal abnormalities), Monosomal karyotype, -5, 5q-, -7, 7q-, 11q23 - non t(9;11), inv(3), t(3;3), t(6;9)\\]', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Full Analysis Set (FAS) was defined as the intention to treat set, which consisted of participants who were randomized and were used for efficacy analyses.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-14', 'size': 1289562, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-16T06:51', 'hasProtocol': True}, {'date': '2022-07-11', 'size': 1677393, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-16T06:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03070093', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-08', 'dispFirstSubmitDate': '2024-03-07', 'completionDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2016-04-22', 'resultsFirstSubmitDate': '2025-07-16', 'studyFirstSubmitQcDate': '2016-04-25', 'dispFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-25', 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of randomization until the date of death from any cause ( maximum duration up to 79 months)', 'description': 'OS was defined as the time from the date of randomization until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact. Kaplan-Meier (KM) estimates was used for analysis.'}], 'secondaryOutcomes': [{'measure': 'Event-free Survival (EFS)', 'timeFrame': 'From the date of randomization until the date of documented relapse from CR, treatment failure or death from any cause, whichever occurred first (up to 39.7 months)', 'description': 'EFS: time from the date of randomization until the date of documented relapse from Complete Remission (CR), treatment failure(failing to achieve CR within 6 cycles of treatment) or death from any cause, whichever occurred first. CR: bone marrow(BM) regenerating normal hematopoietic cells, morphologically leukemia-free state, absolute neutrophil count (ANC) ≥1 × 10\\^9/L, platelet count ≥100 × 10\\^9/L, normal marrow differential with \\<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being red blood cell (RBC) and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. Relapse: reappearance of leukemic blasts \\>2% in the peripheral blood/≥ 5% myeloblasts in the BM unattributable to any other cause/new/reappearance of extramedullary leukemia.'}, {'measure': 'Percentage of Participants With Best Response', 'timeFrame': 'From the date of randomization until the date of death from any cause (up to 57 months)', 'description': 'Best response for a participant was defined as the best measured response (in the order of CR, CR with Incomplete Platelet Recovery (CRp), CR with Incomplete Hematologic Recovery (CRi), and treatment failure) from all post-baseline visits. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\\^9/L, platelet count ≥100 × 10\\^9/L, normal marrow differential with \\<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (\\< 100 × 10\\^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia \\< 1 x 10\\^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required.'}, {'measure': 'Completed Remission (CR) Rate', 'timeFrame': 'From the date of randomization until the date of death from any cause (approximately 49.7 months)', 'description': 'CR rate: number of participants who achieved the best response of CR divided by the number of participants in the analysis population. Participants with unknown or missing response, or who provided no information on response at the end of treatment were included in the denominator when calculating rates. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\\^9/L, platelet count ≥100 × 10\\^9/L, normal marrow differential with \\<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent(1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods.'}, {'measure': 'CRc Rate', 'timeFrame': 'From the date of randomization until the date of death from any cause (approximately 54.5 months)', 'description': 'CRc rate was defined as participants with best response of (CR + CRp + CRi) divided by the number of participants in the analysis population. Participants were classified as: CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\\^9/L, platelet count ≥100 × 10\\^9/L, normal marrow differential with \\<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (\\< 100 × 10\\^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia \\< 1 x 10\\^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required. Percentage of participants with CRc was reported.'}, {'measure': 'Complete Remission With Partial Hematologic Recovery (CRh)', 'timeFrame': 'From the date of randomization until the date of death from any cause (up to 49.7 months)', 'description': 'CRh was defined as the response at a post baseline visit as CRh having bone marrow myeloblast count \\< 5%, partial hematologic recovery ANC ≥ 0.5 x 10\\^9/L and platelets ≥ 50 x 10\\^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood must be ≤ 2% or missing. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\\^9/L, platelet count ≥100 × 10\\^9/L, normal marrow differential with \\<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. Percentage of participants with CRh was reported.'}, {'measure': 'CR/CRh Rate', 'timeFrame': 'From the date of randomization until the date of death from any cause (up to 49.7 months)', 'description': 'CR/CRh rate: number of participants who achieved CR or CRh divided by the number of participants in the analysis population. CR/CRh: CR/CRh if it fulfilled criteria for CR or CRh at the visit. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\\^9/L, platelet count ≥100 × 10\\^9/L, normal marrow differential with \\<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRh: response at a post baseline visit as CRh having bone marrow myeloblast count \\< 5%, partial hematologic recovery ANC ≥ 0.5 x 10\\^9/L and platelets ≥ 50 x 10\\^9/L, no evidence of extramedullary leukemia and cannot be classified as CR. The blast counts in peripheral blood must be ≤ 2% or missing. Percentage of participants with CR/CRh was reported.'}, {'measure': 'Percentage of Participants With Transfusion Conversion Rate', 'timeFrame': 'From baseline up to 57 months', 'description': 'Transfusion conversion rate was defined as the number of participants who were transfusion dependent at baseline period but became transfusion independent at post-baseline period divided by the total number of participants who were transfusion dependent at baseline period.'}, {'measure': 'Percentage of Participants With Transfusion Maintenance Rate', 'timeFrame': 'From baseline up to 57 months', 'description': 'Transfusion maintenance rate was defined as the number of participants who were transfusion independent at baseline period and remained transfusion independent post-baseline period divided by the total number of participants who were transfusion independent at baseline period.'}, {'measure': 'Leukemia-free Survival (LFS)', 'timeFrame': 'From first day of achieving first CRc to the first day of confirmed relapse/death (up to 54.5 months)', 'description': 'LFS: time from the date of first CRc (CR + CRp + CRi) until the date of documented relapse (excluding relapse from PR) or death for participants who achieved CRc. CR: BM regenerating normal hematopoietic cells, morphologically leukemia-free state, ANC ≥1 × 10\\^9/L, platelet count ≥100 × 10\\^9/L, normal marrow differential with \\<5% myeloblast counts, missing/≤2% peripheral blood blast counts and being RBC and platelet transfusion independent (1 week without RBC and platelet transfusion prior to the disease assessment). No evidence of extramedullary leukemia and Auer rods. CRp: achieved CR except incomplete platelet recovery (\\< 100 × 10\\^9/L). CRi: achieved CR except incomplete hematological recovery with residual neutropenia \\< 1 x 10\\^9/L with or without complete platelet recovery. RBC and platelet transfusion independence not required. CRc: fulfilled criteria for CR, CRp or CRi. Based on KM estimates.'}, {'measure': 'Duration of Remission', 'timeFrame': 'From first day of achieving first response to the first day of confirmed relapse/death (up to 56.4 months)', 'description': 'Duration of remission included CRc, CR, CRh, CR/CRh, and response duration \\[CRc + PR\\]. Duration of CRc, CR, CRh: the time from the date of first CRc until the date of first documented relapse for participants who achieved CRc, CR, and CRh, respectively. CR/CRh: fulfilled criteria for CR or CRh at the visit. CRh: marrow blasts \\<5%, ANC ≥0.5×10\\^9/L, platelets ≥50×10\\^9/L, not meeting CR criteria. PR: If marrow myeloblasts between \\<5% and 25% and ≤2% or missing peripheral blood blast and a decrease from baseline of at least 50% in the marrow myeloblasts and no evidence of extramedullary leukemia, the response was classified as PR. If marrow myeloblasts \\<5% and ≤2% or missing peripheral blood blast and no evidence of extramedullary leukemia, the response was classified as PR even with Auer rods.'}, {'measure': 'Change From Baseline in Brief Fatigue Inventory (BFI)', 'timeFrame': 'From baseline to 31 months', 'description': 'The BFI was a tool to assess fatigue severity and impact on daily function in cancer participants over 24 hours. It included 9 items. A global fatigue score was computed by averaging the scores of the 9 items measured on the numeric rating scale. Scores were calculated if ≥5 of 9 items were answered. A higher score indicates a higher degree of fatigue. The first 3 rate fatigue from 0 (no fatigue) to 10 (worst imaginable), with higher scores indicating worse outcomes. The remaining 6 assess how fatigue interferes with daily activities from 0 (no interference) to 10 (completely interferes). A global fatigue score (0-10) was the average of all items, with higher scores indicating worse fatigue. Overall BFI score is reported.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose up to end of study duration (101 months)', 'description': 'An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \\& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE was defined as an adverse event observed after starting administration of the study drug until 30 days from the last study treatment'}, {'measure': 'Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Scores', 'timeFrame': 'From baseline to end of treatment (up to 57 months)', 'description': 'ECOG performance scores at each assessment time were be provided by treatment group. Negative change scores indicated an improvement and positive scores indicate a decline in performance. The grades were defined as follows:\n\n0: Fully active, able to carry on all pre-disease performance without restriction.\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.\n2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.\n3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.\n4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.\n5. Dead.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AML', 'ASP2215', 'Newly Diagnosed AML', 'gilteritinib', 'Acute Myeloid Leukemia (AML)', 'FLT3'], 'conditions': ['Acute Myeloid Leukemia (AML)', 'Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation']}, 'referencesModule': {'references': [{'pmid': '35917453', 'type': 'DERIVED', 'citation': 'Wang ES, Montesinos P, Minden MD, Lee JH, Heuser M, Naoe T, Chou WC, Laribi K, Esteve J, Altman JK, Havelange V, Watson AM, Gambacorti-Passerini C, Patkowska E, Liu S, Wu R, Philipose N, Hill JE, Gill SC, Rich ES, Tiu RV. Phase 3 trial of gilteritinib plus azacitidine vs azacitidine for newly diagnosed FLT3mut+ AML ineligible for intensive chemotherapy. Blood. 2022 Oct 27;140(17):1845-1857. doi: 10.1182/blood.2021014586.'}]}, 'descriptionModule': {'briefSummary': 'This was a clinical study for adult participants who were recently diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some participants with AML have a mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called FLT3. This protein causes the leukemia cells to grow faster.\n\nFor participants with AML who could not receive standard chemotherapy, azacitidine (also known as Vidaza®) was a current standard of care treatment option in the United States. This clinical study tested an experimental medicine called ASP2215, also known as gilteritinib. Gilteritinib worked by stopping the leukemia cells from making the FLT3 protein. This helped stop the leukemia cells from growing faster.\n\nThis study compared two different treatments. Participants were assigned to one of these two groups by chance: a medicine called azacitidine, also known as Vidaza®, or an experimental medicine gilteritinib in combination with azacitidine. There was a twice as much chance to receive both medicines combined than azacitidine alone. The clinical study may help show which treatment helps patients live longer.', 'detailedDescription': 'Participants considered an adult according to local regulation at the time of obtaining informed consent participated in the study.\n\nSafety Cohort Prior to initiation of the randomized trial, 15 participants were enrolled to evaluate the safety and tolerability of ASP2215 given with azacitidine therapy in the study population.\n\nRandomized Trial Approximately 250 participants were randomized in a 2:1 ratio to receive ASP2215 plus azacitidine (Arm AC) or azacitidine only (Arm C). Participants entered the screening period up to 14 days prior to the start of treatment. Participants administered treatment over 28-day cycles.\n\nEarlier protocol versions included a 1:1:1 randomization ratio to receive Arm A: ASP2215, Arm AC: ASP2215 + azacitidine or Arm C: azacitidine. Participants previously randomized to Arm A continued following treatment and assessments as outlined in the protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is considered an adult according to local regulation at the time of obtaining informed consent.\n* Subject has a diagnosis of previously-untreated AML according to World Health Organization (WHO) classification \\[Swerdlow et al, 2008\\] as determined by pathology review at the treating institution.\n* Subject is positive for FLT3 mutation (internal tandem duplication \\[ITD\\] or tyrosine kinase domain \\[TKD\\] \\[D835/I836\\] mutation) (or for Korea only: ITD alone or ITD with concurrent TKD activating mutation) in bone marrow or whole blood as determined by central laboratory. Note: Only requirement of FLT3 mutation assessment by central laboratory is only applicable to the randomization portion of the study.\n* Subject is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:\n\n * Subject is ≥ 65 years of age and ineligible for intensive induction chemotherapy.\n * Subject is ≥ 18 to 64 years of age and has any of the following comorbidities: \\[Ex-US Only\\]: Congestive heart failure (New York Heart Association {NYHA} class ≤ 3) or ejection fraction (Ef) ≤ 50%; \\[US Only\\]: Severe cardiac disorder e.g. congestive heart failure (New York Heart Association \\[NYHA\\] class ≤ 3) requiring treatment, ejection fraction ≤ 50%, or chronic stable angina; \\[Ex-US Only\\]: Creatinine \\> 2 mg/dL (177 µmol/L), dialysis or prior renal transplant; \\[US Only\\]: Creatinine clearance \\< 45 mL/min; ECOG performance status ≥ 2;\n * \\[Ex-US Only\\]: Known pulmonary disease with decreased diffusion capacity of lung for carbon monoxide (DLCO) and/or requiring oxygen ≤ 2 liters per minute; \\[US Only\\] Severe pulmonary disorder (e.g., diffusion capacity of lung for carbon monoxide \\[DLCO\\] ≤ 65% or forced expiratory volume in the first second \\[FEV1\\] ≤ 65%); Prior or current malignancy that does not require concurrent treatment; Subject has received a cumulative anthracycline dose above 400 mg/m2 of doxorubicin (or cumulative maximum dose of another anthracycline). Any other comorbidity incompatible with intensive chemotherapy must be reviewed and approved by the Medical Monitor during screening and before randomization.\n* Subject must meet the following criteria as indicated on the clinical laboratory tests:\n\n * Serum AST and ALT ≤ 3.0 x Institutional upper limit of normal (ULN)\n * Serum total bilirubin ≤ 1.5 x Institutional ULN\n * Serum potassium ≥ Institutional lower limit of normal (LLN)\n * Serum magnesium ≥ Institutional LLN Repletion of potassium and magnesium levels during the screening period is allowed.\n* Subject is suitable for oral administration of study drug.\n* Female subject is eligible to participate if female subject is not pregnant and at least one of the following conditions applies:\n\n * Not a woman of childbearing potential (WOCBP); OR\n * WOCBP agrees to follow the contraceptive guidance starting at screening and continue throughout the study period, and for at least 180 days after the final study drug administration.\n* Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 60 days after the final study drug administration.\n* Female subject must not donate ova starting at screening and throughout the study period, and for 180 days after the final study drug administration.\n* Male subject with female partners of childbearing potential must agree to use contraception as detailed in Contraception Requirements, starting at screening and continue throughout the study period, and for 120 days after the final study drug administration.\n* Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration.\n* Subject agrees not to participate in another interventional study while on treatment.\n\nExclusion Criteria:\n\n* Subject was diagnosed as acute promyelocytic leukemia (APL).\n* Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).\n* Subject has received previous therapy for AML, with the exception of the following:\n\n * Emergency leukapheresis\n * Hydroxyurea\n * Preemptive treatment with retinoic acid prior to exclusion of APL ≤ 7 days\n * Growth factor or cytokine support\n * Steroids\n* Subject has clinically active central nervous system leukemia.\n* Subject has been diagnosed with another malignancy that requires concurrent treatment (with the exception of hormone therapy limited to those therapies that prevent recurrence and/or spread of cancer) or hepatic malignancy regardless of need for treatment.\n* Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 CYP3A/P-glycoprotein (P-gp).\n* Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-gp with the exception of drugs that are considered absolutely essential for the care of the subject.\n* Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.\n* Subject has congestive heart failure classified as New York Heart Association Class IV.\n* Subject with mean Fridericia-corrected QT interval (QTcF) \\> 480 ms at screening based on central reading.\n* Subject with a history of Long QT Syndrome at screening.\n* \\[Ex-US Only\\]: Subject has known pulmonary function tests with diffusion capacity of lung for carbon monoxide (DLCO) ≤ 50%, forced expiratory volume in the first second (FEV1) ≤ 60%, dyspnea at rest or requiring oxygen or any pleural neoplasm (Transient use of supplemental oxygen is allowed.)\n* Subject has active hepatitis B or C or other active hepatic disorder.\n\n * Subjects with positive hepatitis B surface antigen (HBsAg) or detectable hepatitis B DNA are not eligible.\n * Subjects with negative HBsAg, positive hepatitis B core antibody and negative hepatitis B surface antibody will be eligible if hepatitis B DNA is undetectable.\n * Subjects with antibodies to hepatitis C virus will be eligible if hepatitis C RNA is undetectable\n* Subject has any condition which makes the subject unsuitable for study participation, including any contraindications of azacitidine.\n* Subject has a known or suspected hypersensitivity to ASP2215, azacitidine or any components of the formulations used.\n* \\[US Only\\]: Subject is ≥ 65 to 74 years of age, suitable for and willing to receive intensive induction chemotherapy.'}, 'identificationModule': {'nctId': 'NCT02752035', 'briefTitle': 'A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 3 Multicenter, Open-label, Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy', 'orgStudyIdInfo': {'id': '2215-CL-0201'}, 'secondaryIdInfos': [{'id': '2015-001790-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safety Cohort: Gilteritinib + Azacitidine (AZA)', 'description': 'Participants received 80 mg (2 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles and 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle. Depending on the safety cohort data ,the decision to initiate the randomized trial at the targeted dose was made. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.', 'interventionNames': ['Drug: gilteritinib', 'Drug: azacitidine']}, {'type': 'EXPERIMENTAL', 'label': 'Randomized Cohort: Gilteritinib + AZA', 'description': 'Participants received 120 mg(3 tablets of 40 mg)of gilteritinib orally once daily for continuous 28-day cycles in combination with 75mg/m\\^2 of AZA daily via subcutaneous injection or IV infusion for 7days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator,unacceptable toxicity occurred,or the participant met another treatment discontinuation criterion.After the end of treatment period,participants were followed up for 30-day follow up period.Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment,EQ-5D-5L,remission status and survival (cause and date of death).Participants in long-term follow-up who were no longer receiving treatment were followed every 3months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study,as further survival data were no longer needed.', 'interventionNames': ['Drug: gilteritinib']}, {'type': 'EXPERIMENTAL', 'label': 'Randomized Cohort: AZA', 'description': 'Participants received 75 mg/m\\^2 of AZA daily via subcutaneous injection or intravenous infusion for 7 days of each 28-day treatment cycle until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. After the end of treatment period, participants were followed up for 30- day follow up period. Participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death). Participants in long-term follow-up who were no longer receiving treatment were followed every 3 months for survival until the implementation of the final protocol version 13.0, at which time they were discontinued from the study, as further survival data were no longer needed.', 'interventionNames': ['Drug: gilteritinib', 'Drug: azacitidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Randomized Cohort: Gilteritinib', 'description': 'Participants received 120 mg (3 tablets of 40 mg) of gilteritinib orally once daily for continuous 28-day cycles until the participant no longer received clinical benefit from therapy in the opinion of the investigator, unacceptable toxicity occurred or the participant met another treatment discontinuation criterion. However, randomization to this arm was removed in protocol version 7.0. Participants previously randomized to this arm continued following treatment and assessments as outlined in the protocol.', 'interventionNames': ['Drug: azacitidine']}], 'interventions': [{'name': 'gilteritinib', 'type': 'DRUG', 'otherNames': ['ASP2215'], 'description': 'Tablet, oral', 'armGroupLabels': ['Randomized Cohort: AZA', 'Randomized Cohort: Gilteritinib + AZA', 'Safety Cohort: Gilteritinib + Azacitidine (AZA)']}, {'name': 'azacitidine', 'type': 'DRUG', 'description': 'Subcutaneous injection or intravenous infusion', 'armGroupLabels': ['Randomized Cohort: AZA', 'Randomized Cohort: Gilteritinib', 'Safety Cohort: Gilteritinib + Azacitidine (AZA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA David Geffen School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '60611-5975', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University Cancer Center - Hematology/Oncology', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center - John Theurer Cancer Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hematology-Oncology Associates of Northern NJ', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College-New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '26615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GHS Cancer Institute', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '84143', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'LDS Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '2170', 'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Site AU61004', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, 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