Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT02997202
Status:
COMPLETED
Last Update Posted:
2025-01-17
First Post:
2016-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astellas.resultsdisclosure@astellas.com', 'phone': '8008887704', '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}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality: From the date of randomization up to 64 months and 22 days Adverse events: From the date of randomization through 30 days after the last dose, up to 25 months and 22 days', 'description': 'Safety Analysis Population. All-cause mortality and serious and other adverse events was reported for all randomized participants who received actual dose of study drug during the study. Therefore, 1 participant randomized to placebo actually received gilteritinib, hence, was included under gilteritinib arm. One participant randomized to gilteritinib arm did not receive any treatment. Serious and other adverse events was reported up to 30 days after last dose.', 'eventGroups': [{'id': 'EG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.', 'otherNumAtRisk': 178, 'deathsNumAtRisk': 178, 'otherNumAffected': 175, 'seriousNumAtRisk': 178, 'deathsNumAffected': 42, 'seriousNumAffected': 92}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.', 'otherNumAtRisk': 177, 'deathsNumAtRisk': 177, 'otherNumAffected': 169, 'seriousNumAtRisk': 177, 'deathsNumAffected': 44, 'seriousNumAffected': 81}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 36, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 29, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 55, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 48, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 48, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 47, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 34, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 34, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 40, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 29, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 30, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 27, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 44, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 40, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 41, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 21, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 64, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 43, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 44, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 21, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 31, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 26, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 25, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 34, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 40, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 39, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 35, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 21, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Acute graft versus host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 90, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 91, 'numAffected': 64}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Chronic graft versus host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 156, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 131, 'numAffected': 77}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Cytomegalovirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 34, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}], 'seriousEvents': [{'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Cytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Febrile 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'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Gastroenteritis norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Genital infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Klebsiella sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Lower respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Lower respiratory tract infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Lower respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Oesophageal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Pneumocystis jirovecii pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Pneumonia mycoplasmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Pseudomonal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Respiratory tract infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Staphylococcal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Upper respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Viral sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Viral skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relapse-free Survival (RFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not estimable because less than 50% of participants had event (data was estimated using Kaplan-Meier \\[KM\\] and it requires at least 50% of event to be able to calculate time using KM).', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM).', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0518', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.679', 'ciLowerLimit': '0.459', 'ciUpperLimit': '1.005', 'groupDescription': 'Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization up to 64 months and 22 days', 'description': 'RFS was defined as the time from the date of randomization until the date of documented morphological relapse, or death from any cause, whichever occurred first. Morphological relapse was defined as documentation of any of the following events:\n\n* BM blasts ≥ 5% (not attributable to regenerating BM)\n* Any circulating blasts (not attributable to regenerating BM or growth factors)\n* Presence of extramedullary blast foci per Revised International Working Group (RIWG) criteria\n* The earliest date of any of the relapse event was used for RFS.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM).', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM).', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.4394', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.846', 'ciLowerLimit': '0.554', 'ciUpperLimit': '1.293', 'groupDescription': 'Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization up to 64 months and 22 day', 'description': 'OS was defined as the time from randomization until the date of death from any cause (death date - first dose date + 1). For a Participant who were not known to have died by the end of study follow-up, OS was censored at the date of last contact (date of last contact - first dose date + 1).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization through 30 days after the last dose, up to 25 months and 22 days', 'description': 'An Adverse event (AE) was any untoward medical occurrence in a participant administered a study drug, and which did not have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether considered related to the medicinal product.\n\nTEAE defined as an AE event observed through 30 days after the last dose.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Population: consisted of all participants who took at least 1 dose of study drug (gilteritinib or placebo).'}, {'type': 'SECONDARY', 'title': 'Karnofsky Performance Status Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.20', 'spread': '10.65', 'groupId': 'OG000'}, {'value': '84.73', 'spread': '10.69', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.12', 'spread': '8.34', 'groupId': 'OG000'}, {'value': '91.67', 'spread': '9.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, month 24', 'description': 'KPS scores of participants were reported. KPS was a standard way of measuring ability of cancer participants to perform ordinary tasks. It was 11 level score which ranged between 0-100%. 100 =Normal, no complaints, no evidence of disease 90 =Able to carry on normal activity, minor signs or symptoms of disease 80 =Normal activity with effort, some signs or symptoms of disease 70 =Care for self, unable to carry on normal activity or to do work 60 =Required occasional assistance but was able to care for most of his needs 50 =Required considerable assistance \\& frequent medical care 40 =Disabled, required special care \\& assistance 30 = Severely disabled, hospitalization indicated, although death not imminent 20 =Very sick, hospitalization necessary, active supportive treatment necessary 10 =moribund fatal processes progressing rapidly 0 =Dead.', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Population with available data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Non-relapse Mortality (NRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '19.2'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '11.0'}]}]}], 'analyses': [{'pValue': '0.0209', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3080', 'ciLowerLimit': '1.1352', 'ciUpperLimit': '4.6922', 'groupDescription': "Based on Fine \\& Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \\& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.", 'statisticalMethod': 'Fine-Grays Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization up to 64 months and 22 days', 'description': 'NRM was defined as death from any cause other than relapse or disease progression (DP). Relapse was defined as documentation of any of the following events:\n\n* BM blasts ≥ 5% (not attributable to regenerating BM)\n* Any circulating blasts (not attributable to regenerating BM or growth factors)\n* Presence of extramedullary blast foci per RIWG criteria\n* The earliest date of any of the relapse event were used for RFS. DP: \\>=20% increase in sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline, sum must also be absolute increase of \\>=5 mm. Unequivocal progression of existing non-target lesions. Appearance of at least 1 new lesion. Incidence of NRM was estimated using the cumulative incidence function, treating relapse/progression as a competing risk.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM).', 'groupId': 'OG000', 'lowerLimit': '19.65', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM).', 'groupId': 'OG001', 'lowerLimit': '15.05', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.6417', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.930', 'ciLowerLimit': '0.686', 'ciUpperLimit': '1.261', 'groupDescription': 'Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization up to 64 months and 22 days', 'description': 'EFS: Time from date of randomization until documented relapse, or premature discontinuation of treatment or initiation of other anti-leukemic treatment or death from any cause, whichever occurred first.\n\nRelapse was defined as documentation of any of following events:\n\n* BM blasts ≥ 5% (not attributable to regenerating BM)\n* Any circulating blasts (not attributable to regenerating BM or growth factors)\n* Presence of extramedullary blast foci per RIWG criteria\n* The earliest date of any of relapse event were used for RFS.\n\nAnti-leukemic treatment was defined as hypomethylating agents, chemotherapy, oral anticancer agents, Donor lymphocyte infusion (DLI) or cellular therapies given because of detectable disease, not meeting R-IWG criteria for relapse.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Emergent Acute Graft vs. Host Disease (aGVHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}], 'classes': [{'title': 'aGVHD II to IV', 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '22.5'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '13.6', 'upperLimit': '25.6'}]}]}, {'title': 'aGVHD III to IV', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '10.1'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '7.9'}]}]}], 'analyses': [{'pValue': '0.6410', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8938', 'ciLowerLimit': '0.5574', 'ciUpperLimit': '1.4330', 'groupDescription': "aGVHD II to IV:\n\nBased on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \\& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.", 'statisticalMethod': 'Fine-Grays model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4128', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4254', 'ciLowerLimit': '0.6103', 'ciUpperLimit': '3.3289', 'groupDescription': "aGVHD III to IV:\n\nBased on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \\& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.", 'statisticalMethod': 'Fine-Grays model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization up to 6 months', 'description': 'The cumulative incidence at 6 months after randomization of grades II-IV and grades III-IV aGVHD were reported, treating death prior to aGVHD as the competing risk. It was graded according to diagnosis and severity scoring used by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The acute GVHD algorithm calculated the grade based on the organ (skin, gastrointestinal (GI)and liver) stage and etiology/biopsy reported on the weekly GVHD form. Grade I aGVHD was defined as Skin stage of 1-2 and stage 0 for both GI and liver organs. Grade II aGVHD was stage 3 of skin, or stage 1 of GI, or stage 1 of liver. Grade III is stage 2-4 for GI, or stage 2-3 of liver. Grade IV was stage 4 of skin, or stage 4 of liver. Grade IV was the worst outcome. Treatment emergent was defined as an event observed through 30 days after the last dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Emergent Chronic GVHD at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '48.5', 'upperLimit': '64.6'}, {'value': '48.1', 'groupId': 'OG001', 'lowerLimit': '39.5', 'upperLimit': '56.2'}]}]}], 'analyses': [{'pValue': '0.1725', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2360', 'ciLowerLimit': '0.9116', 'ciUpperLimit': '1.6757', 'groupDescription': "Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \\& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.", 'statisticalMethod': 'Fine-Grays Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization up to 12 months', 'description': 'Chronic GVHD was graded according to diagnosis and severity scoring from the National Institute of Health (NIH) 2014 Consensus Criteria. Eight organs - skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia were scored on a 0-3 scale to reflect degree of chronic GVHD involvement, where 0 = no involvement/no symptoms \\& 3 indicated the worst symptom. This system staged severity in each individual organ, and then a global score defined as mild, moderate or severe, based on number of organs involved and organ severity score was calculated. The cumulative incidence of chronic GVHD (mild, moderate, severe) at 12 months after randomization was reported, treating death prior to chronic GVHD as the competing risk. Treatment emergent was defined as an event observed through 30 days after the last dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Emergent Chronic GVHD at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000', 'lowerLimit': '53.3', 'upperLimit': '69.4'}, {'value': '51.8', 'groupId': 'OG001', 'lowerLimit': '42.9', 'upperLimit': '59.9'}]}]}], 'analyses': [{'pValue': '0.1725', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2360', 'ciLowerLimit': '0.9116', 'ciUpperLimit': '1.6757', 'groupDescription': "Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \\& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.", 'statisticalMethod': 'Fine-Grays Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization up to 24 months', 'description': 'Chronic GVHD was graded according to diagnosis and severity scoring from the NIH 2014 Consensus Criteria. Eight organs- skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are scored on a 0-3 scale to reflect degree of chronic GVHD involvement where 0 = no involvement/no symptoms \\& 3 indicated the worst symptom. This system staged severity in each individual organ, and then a global score defined as mild, moderate or severe, based on number of organs involved and organ severity score was calculated. The cumulative incidence of chronic GVHD (mild, moderate, severe) at 24 months after randomization was reported, treating death prior to chronic GVHD as the competing risk. Treatment emergent was defined as an event observed through 30 days after the last dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With FMS-like Tyrosine Kinase 3/Internal Tandem Duplication (FLT3/ITD) Minimal Residual Disease (MRD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}], 'classes': [{'title': 'MRD Eradication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '98.4'}, {'value': 'NA', 'comment': 'Data was not estimable because no participants in Placebo group were followed up to 1 year (cumulative incidence function requires at least 1 participant to calculate the cumulative incidence rate).', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'MRD 10^-4 Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '12.4'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '15.0'}]}]}], 'analyses': [{'pValue': '0.2029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4537', 'ciLowerLimit': '0.5126', 'ciUpperLimit': '23.2687', 'groupDescription': 'MRD Eradication', 'statisticalMethod': 'Fine-Grays Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4077', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7073', 'ciLowerLimit': '0.3116', 'ciUpperLimit': '1.6055', 'groupDescription': 'MRD 10\\^-4 Detection', 'statisticalMethod': 'Fine-Grays Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization up to 64 months and 22 days', 'description': 'The presence of MRD was considered Detectable in participants who were FLT3/ITD MRD undetectable prior to randomization if log10-transformed overall FLT3/ITD mutation ratio greater than -4 otherwise presence of MRD was considered Not Detectable. Participants who had detectable FLT3/ITD MRD prior to randomization were considered eradicated if log10-transformed overall FLT3/ITD mutation ratio ≤ -4. Incidence of MRD Eradication and Detection were estimated using the cumulative incidence function, treating death during MRD assessment period without documentation of MRD event as competing risk.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '17.8'}, {'value': '26.7', 'groupId': 'OG001', 'lowerLimit': '20.3', 'upperLimit': '33.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3729', 'ciLowerLimit': '0.2243', 'ciUpperLimit': '0.6199', 'groupDescription': "Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \\& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.", 'statisticalMethod': 'Fine-Grays Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization up to 64 months and 22 days', 'description': 'Cumulative incidence of relapse was reported, treating death in remission as a competing risk. Relapse was defined as documentation of any of the following events:\n\n* BM blasts ≥ 5% (not attributable to regenerating BM)\n* Any circulating blasts (not attributable to regenerating BM or growth factors)\n* Presence of extramedullary blast foci per RIWG criteria\n* The earliest date of any of the relapse event were used for RFS.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Emergent Infection by Severity.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000', 'lowerLimit': '31.3', 'upperLimit': '47.8'}, {'value': '27.2', 'groupId': 'OG001', 'lowerLimit': '19.9', 'upperLimit': '35.0'}]}]}], 'analyses': [{'pValue': '0.0568', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4848', 'ciLowerLimit': '0.9886', 'ciUpperLimit': '2.2300', 'groupDescription': "Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \\& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.", 'statisticalMethod': 'Fine-Grays model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization through 30 days after the last dose, up to 25 months and 22 days', 'description': 'Severity of Infection was assessed based on the following criteria:\n\nGrade 1-Mild Asymptomatic or mild symptoms, clinical or diagnostic observations noted intervention not indicated.\n\nGrade 2-Moderate Local or noninvasive intervention indicated. Grade 3-Severe Medically significant but not immediately life threatening, hospitalization or prolonged hospitalization. Grade 4-Life Threatening Life threatening consequences, urgent intervention indicated.\n\nGrade 5-Death related to the AE. Cumulative incidence of grade 3 to 5 infections were reported, treating death (grade 5) as a competing event. Treatment emergent was defined as an event observed through 30 days after the last dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 milligrams (mg) (three tablets of 40 mg) orally, once daily (QD) for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1 participant randomized to gilteritinib did not take any gilteritinib or placebo', 'groupId': 'FG000', 'numSubjects': '178'}, {'comment': '1 participant randomized to placebo took gilteritinib', 'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'Safety Analysis Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '177'}]}, {'type': 'Intent to Treat (ITT) Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '62'}]}], 'dropWithdraws': [{'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '45'}]}]}], 'recruitmentDetails': 'Participants with FMS-like tyrosine kinase 3/Internal tandem duplication (FLT3/ITD) acute myeloid leukemia (AML) in first morphological complete remission (CR1) including complete remission with incomplete platelet recovery (CRp) \\& complete remission with incomplete hematologic recovery (CRi) undergoing allogeneic hematopoietic cell transplant (HCT) were enrolled in the study.', 'preAssignmentDetails': 'Randomization was stratified by: Conditioning regimen intensity myeloablative vs reduced intensity/non-myeloablative (RIC/NMA); Time from first day of hematopoietic cell infusion to randomization (30 to 60 vs 61 to 90 days); Presence vs absence of/unknown, Minimal Residual Disease-4 (MRD-4) from the most recent pre-registration Bone marrow (BM).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '356', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '51.8', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '51', 'spread': '12.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with conditioning regimen intensity', 'classes': [{'title': 'MAC', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}, {'title': 'RIC/NMA', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Conditioning regimen intensity categorized by myeloablative conditioning (MAC) vs RIC/NMA were reported. MAC regimen consisted: Total body irradiation (TBI) ≥ 5 gray (Gy) single dose or ≥ 8 Gy fractionated/oral Busulfan \\> 8 milligrams per kilogram (mg/kg)/6.4 mg/kg intravenous (IV) (total dose)/treosulfan \\>30000 milligrams per square meter (mg/m\\^2)/elphalan \\>150 mg/m\\^2/thiotepa ≥10 mg/kg. RIC/NMA: Any regimen that did not meet MAC regimen: Interactive Response Technology (IRT) analysis was used.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants With Time from first day of hematopoietic cell infusion to randomization', 'classes': [{'title': '30-60 days', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}]}, {'title': '61-90 days', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with time from first day of hematopoietic cell infusion to randomization categorized as 30 to 60 days vs 61 to 90 days were reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Presence of MRD', 'classes': [{'title': 'Present', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Absent/Unknown', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with presence versus absence of, or unknown, MRD-4 from the most recent pre-registration BM aspirate was reported. IRT analysis was used. The presence of MRD was considered "Detectable" if log10-transformed overall FLT3/ITD mutation ratio was greater than -4; otherwise, the presence of MRD was considered "Not Detectable.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intention-to-Treat (ITT) population: All randomized participants were included in this population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-19', 'size': 2109323, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-06T02:36', 'hasProtocol': True}, {'date': '2023-02-21', 'size': 1040997, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-06T02:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 356}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03070093', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-01', 'dispFirstSubmitDate': '2024-02-28', 'completionDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2016-12-01', 'resultsFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2016-12-15', 'dispFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-16', 'studyFirstPostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse-free Survival (RFS)', 'timeFrame': 'From the date of randomization up to 64 months and 22 days', 'description': 'RFS was defined as the time from the date of randomization until the date of documented morphological relapse, or death from any cause, whichever occurred first. Morphological relapse was defined as documentation of any of the following events:\n\n* BM blasts ≥ 5% (not attributable to regenerating BM)\n* Any circulating blasts (not attributable to regenerating BM or growth factors)\n* Presence of extramedullary blast foci per Revised International Working Group (RIWG) criteria\n* The earliest date of any of the relapse event was used for RFS.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of randomization up to 64 months and 22 day', 'description': 'OS was defined as the time from randomization until the date of death from any cause (death date - first dose date + 1). For a Participant who were not known to have died by the end of study follow-up, OS was censored at the date of last contact (date of last contact - first dose date + 1).'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAE)', 'timeFrame': 'From the date of randomization through 30 days after the last dose, up to 25 months and 22 days', 'description': 'An Adverse event (AE) was any untoward medical occurrence in a participant administered a study drug, and which did not have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether considered related to the medicinal product.\n\nTEAE defined as an AE event observed through 30 days after the last dose.'}, {'measure': 'Karnofsky Performance Status Scores', 'timeFrame': 'Baseline, month 24', 'description': 'KPS scores of participants were reported. KPS was a standard way of measuring ability of cancer participants to perform ordinary tasks. It was 11 level score which ranged between 0-100%. 100 =Normal, no complaints, no evidence of disease 90 =Able to carry on normal activity, minor signs or symptoms of disease 80 =Normal activity with effort, some signs or symptoms of disease 70 =Care for self, unable to carry on normal activity or to do work 60 =Required occasional assistance but was able to care for most of his needs 50 =Required considerable assistance \\& frequent medical care 40 =Disabled, required special care \\& assistance 30 = Severely disabled, hospitalization indicated, although death not imminent 20 =Very sick, hospitalization necessary, active supportive treatment necessary 10 =moribund fatal processes progressing rapidly 0 =Dead.'}, {'measure': 'Percentage of Participants With Non-relapse Mortality (NRM)', 'timeFrame': 'From the date of randomization up to 64 months and 22 days', 'description': 'NRM was defined as death from any cause other than relapse or disease progression (DP). Relapse was defined as documentation of any of the following events:\n\n* BM blasts ≥ 5% (not attributable to regenerating BM)\n* Any circulating blasts (not attributable to regenerating BM or growth factors)\n* Presence of extramedullary blast foci per RIWG criteria\n* The earliest date of any of the relapse event were used for RFS. DP: \\>=20% increase in sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline, sum must also be absolute increase of \\>=5 mm. Unequivocal progression of existing non-target lesions. Appearance of at least 1 new lesion. Incidence of NRM was estimated using the cumulative incidence function, treating relapse/progression as a competing risk.'}, {'measure': 'Event-free Survival (EFS)', 'timeFrame': 'From the date of randomization up to 64 months and 22 days', 'description': 'EFS: Time from date of randomization until documented relapse, or premature discontinuation of treatment or initiation of other anti-leukemic treatment or death from any cause, whichever occurred first.\n\nRelapse was defined as documentation of any of following events:\n\n* BM blasts ≥ 5% (not attributable to regenerating BM)\n* Any circulating blasts (not attributable to regenerating BM or growth factors)\n* Presence of extramedullary blast foci per RIWG criteria\n* The earliest date of any of relapse event were used for RFS.\n\nAnti-leukemic treatment was defined as hypomethylating agents, chemotherapy, oral anticancer agents, Donor lymphocyte infusion (DLI) or cellular therapies given because of detectable disease, not meeting R-IWG criteria for relapse.'}, {'measure': 'Percentage of Participants With Treatment Emergent Acute Graft vs. Host Disease (aGVHD)', 'timeFrame': 'From the date of randomization up to 6 months', 'description': 'The cumulative incidence at 6 months after randomization of grades II-IV and grades III-IV aGVHD were reported, treating death prior to aGVHD as the competing risk. It was graded according to diagnosis and severity scoring used by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The acute GVHD algorithm calculated the grade based on the organ (skin, gastrointestinal (GI)and liver) stage and etiology/biopsy reported on the weekly GVHD form. Grade I aGVHD was defined as Skin stage of 1-2 and stage 0 for both GI and liver organs. Grade II aGVHD was stage 3 of skin, or stage 1 of GI, or stage 1 of liver. Grade III is stage 2-4 for GI, or stage 2-3 of liver. Grade IV was stage 4 of skin, or stage 4 of liver. Grade IV was the worst outcome. Treatment emergent was defined as an event observed through 30 days after the last dose.'}, {'measure': 'Percentage of Participants With Treatment Emergent Chronic GVHD at 12 Months', 'timeFrame': 'From the date of randomization up to 12 months', 'description': 'Chronic GVHD was graded according to diagnosis and severity scoring from the National Institute of Health (NIH) 2014 Consensus Criteria. Eight organs - skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia were scored on a 0-3 scale to reflect degree of chronic GVHD involvement, where 0 = no involvement/no symptoms \\& 3 indicated the worst symptom. This system staged severity in each individual organ, and then a global score defined as mild, moderate or severe, based on number of organs involved and organ severity score was calculated. The cumulative incidence of chronic GVHD (mild, moderate, severe) at 12 months after randomization was reported, treating death prior to chronic GVHD as the competing risk. Treatment emergent was defined as an event observed through 30 days after the last dose.'}, {'measure': 'Percentage of Participants With Treatment Emergent Chronic GVHD at 24 Months', 'timeFrame': 'From the date of randomization up to 24 months', 'description': 'Chronic GVHD was graded according to diagnosis and severity scoring from the NIH 2014 Consensus Criteria. Eight organs- skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are scored on a 0-3 scale to reflect degree of chronic GVHD involvement where 0 = no involvement/no symptoms \\& 3 indicated the worst symptom. This system staged severity in each individual organ, and then a global score defined as mild, moderate or severe, based on number of organs involved and organ severity score was calculated. The cumulative incidence of chronic GVHD (mild, moderate, severe) at 24 months after randomization was reported, treating death prior to chronic GVHD as the competing risk. Treatment emergent was defined as an event observed through 30 days after the last dose.'}, {'measure': 'Percentage of Participants With FMS-like Tyrosine Kinase 3/Internal Tandem Duplication (FLT3/ITD) Minimal Residual Disease (MRD)', 'timeFrame': 'From the date of randomization up to 64 months and 22 days', 'description': 'The presence of MRD was considered Detectable in participants who were FLT3/ITD MRD undetectable prior to randomization if log10-transformed overall FLT3/ITD mutation ratio greater than -4 otherwise presence of MRD was considered Not Detectable. Participants who had detectable FLT3/ITD MRD prior to randomization were considered eradicated if log10-transformed overall FLT3/ITD mutation ratio ≤ -4. Incidence of MRD Eradication and Detection were estimated using the cumulative incidence function, treating death during MRD assessment period without documentation of MRD event as competing risk.'}, {'measure': 'Percentage of Participants With Relapse', 'timeFrame': 'From the date of randomization up to 64 months and 22 days', 'description': 'Cumulative incidence of relapse was reported, treating death in remission as a competing risk. Relapse was defined as documentation of any of the following events:\n\n* BM blasts ≥ 5% (not attributable to regenerating BM)\n* Any circulating blasts (not attributable to regenerating BM or growth factors)\n* Presence of extramedullary blast foci per RIWG criteria\n* The earliest date of any of the relapse event were used for RFS.'}, {'measure': 'Percentage of Participants With Treatment Emergent Infection by Severity.', 'timeFrame': 'From the date of randomization through 30 days after the last dose, up to 25 months and 22 days', 'description': 'Severity of Infection was assessed based on the following criteria:\n\nGrade 1-Mild Asymptomatic or mild symptoms, clinical or diagnostic observations noted intervention not indicated.\n\nGrade 2-Moderate Local or noninvasive intervention indicated. Grade 3-Severe Medically significant but not immediately life threatening, hospitalization or prolonged hospitalization. Grade 4-Life Threatening Life threatening consequences, urgent intervention indicated.\n\nGrade 5-Death related to the AE. Cumulative incidence of grade 3 to 5 infections were reported, treating death (grade 5) as a competing event. Treatment emergent was defined as an event observed through 30 days after the last dose.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gilteritinib', 'ASP2215', 'Safety and Efficacy', 'Acute Myeloid Leukemia'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '40590852', 'type': 'DERIVED', 'citation': 'Levis MJ, Hamadani M, Logan BR, Jones RJ, Singh AK, Litzow MR, Wingard JR, Papadopoulos EB, Perl AE, Soiffer RJ, Ustun C, Oshima MU, Uy GL, Waller EK, Vasu S, Solh M, Mishra A, Muffly LS, Kim HJ, Stelljes M, Najima Y, Onozawa M, Thomson K, Chen C, Hasabou N, Rosales M, Hill JE, Gill SC, Nuthethi R, King D, Mendizabal A, Devine SM, Horowitz MM, Chen YB. Impact of transplant conditioning, NPM1 mutations, and measurable residual disease in FLT3-ITD acute myeloid leukemia. Blood Adv. 2025 Oct 28;9(20):5123-5133. doi: 10.1182/bloodadvances.2025016306.'}, {'pmid': '39775763', 'type': 'DERIVED', 'citation': 'Levis MJ, Hamadani M, Logan BR, Jones RJ, Singh AK, Litzow MR, Wingard JR, Papadopoulos EB, Perl AE, Soiffer RJ, Ustun C, Oshima MU, Uy GL, Waller EK, Vasu S, Solh M, Mishra A, Muffly LS, Kim HJ, Stelljes M, Najima Y, Onozawa M, Thomson K, Nagler A, Wei AH, Marcucci G, Chen C, Hasabou N, Rosales M, Hill J, Gill SC, Nuthethi R, King D, Mendizabal A, Devine SM, Horowitz MM, Chen YB. Measurable residual disease and posttransplantation gilteritinib maintenance for patients with FLT3-ITD-mutated AML. Blood. 2025 May 8;145(19):2138-2148. doi: 10.1182/blood.2024025154.'}, {'pmid': '39167766', 'type': 'DERIVED', 'citation': 'Hamilton BK, Pandya BJ, Ivanescu C, Elsouda D, Hamadani M, Chen YB, Levis MJ, Ueda Oshima M, Litzow MR, Soiffer RJ, Ustun C, Perl AE, Singh AK, Geller N, Hasabou N, Rosales M, Cella D, Corredoira L, Pestana C, Horowitz MM, Logan B. Health-related quality of life with gilteritinib vs placebo posttransplant for FLT3-ITD+ acute myeloid leukemia. Blood Adv. 2024 Oct 8;8(19):5091-5099. doi: 10.1182/bloodadvances.2024013746.'}, {'pmid': '38663769', 'type': 'DERIVED', 'citation': 'Pandya BJ, Burns LJ, Wang T, Xie B, Touya M, Spalding J, Block A, Kuperman G, Young C. Clinical Outcomes and Treatment Patterns in Adults With FLT3-ITDmut+ Acute Myeloid Leukemia Undergoing Allogeneic Hemopoietic Cell Transplantation in the United States and Canada. Transplant Cell Ther. 2024 Jul;30(7):683.e1-683.e13. doi: 10.1016/j.jtct.2024.04.016. Epub 2024 Apr 23.'}, {'pmid': '38471061', 'type': 'DERIVED', 'citation': 'Levis MJ, Hamadani M, Logan B, Jones RJ, Singh AK, Litzow M, Wingard JR, Papadopoulos EB, Perl AE, Soiffer RJ, Ustun C, Ueda Oshima M, Uy GL, Waller EK, Vasu S, Solh M, Mishra A, Muffly L, Kim HJ, Mikesch JH, Najima Y, Onozawa M, Thomson K, Nagler A, Wei AH, Marcucci G, Geller NL, Hasabou N, Delgado D, Rosales M, Hill J, Gill SC, Nuthethi R, King D, Wittsack H, Mendizabal A, Devine SM, Horowitz MM, Chen YB; BMT-CTN 1506/MORPHO Study Investigators. Gilteritinib as Post-Transplant Maintenance for AML With Internal Tandem Duplication Mutation of FLT3. J Clin Oncol. 2024 May 20;42(15):1766-1775. doi: 10.1200/JCO.23.02474. Epub 2024 Mar 12.'}], 'seeAlsoLinks': [{'url': 'https://www.trialsummaries.com/Study/StudyDetails?id=14519&tenant=MT_AST_9011', 'label': 'Link to plain language summary of the study on the Trial Results Summaries website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who underwent hematopoietic stem cell transplant (HCT) and were randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.', 'detailedDescription': 'Participants with FLT3/ITD AML in first morphologic complete remission (CR1) undergone allogeneic hematopoietic stem cell transplant (HCT) were randomized to receive gilteritinib or placebo 30 to 90 days after HCT for a two year period. Participants wiere stratified according to: 1) conditioning regimen intensity (myeloablative vs. reduced intensity/non-myeloablative), 2) time from first day of hematopoietic cell infusion to randomization (30-60 days vs. 61-90 days) and 3) presence vs absence of or unknown minimal residual disease (MRD) from the most recent pre-registration bone marrow (BM) aspirate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Registration Inclusion Criteria\n\n* Participant is considered a suitable candidate for HCT and has an acceptable source of allogeneic donor stem cells, as defined per institutional practice (allogeneic HCT for any donor source \\[matched sibling, unrelated donor (URD), mismatched URD, related haploidentical, or umbilical cord blood\\] and any graft source \\[umbilical cord, BM, peripheral blood (PB)\\], and any conditioning \\[myeloablative conditioning (MAC), reduced intensity conditioning (RIC), or non-myeloablative conditioning (NMA)\\] will be permitted).\n* Participant is considered a legal adult by local regulation at the time of signing informed consent form (ICF).\n* Participant consents to allow access to diagnostic BM aspirate or PB sample and/or the DNA derived from that sample, if available, that may be used to validate a companion diagnostic that is being developed in parallel with gilteritinib.\n* Participant has confirmed, morphologically documented AML in CR1. For the purposes of registration, CR1 will be defined as \\< 5% blasts in the BM with no morphologic characteristics of acute leukemia (e.g., Auer Rods) in the BM with no evidence of extramedullary disease such as central nervous system involvement or granulocytic sarcoma.\n\n * Participant has not received more than 2 cycles of induction chemotherapy to achieve CR1. The induction cycles can be the same regimen or different regimens. The regimen(s) may contain conventional agents, investigational agents, or a combination of both.\n * Participants with CR with incomplete count recovery (CRp or CRi) are allowed. Incomplete platelet recovery (CRp) is defined as CR with platelet count \\< 100 x 109/L. Incomplete blood count recovery (CRi) is defined as CR with residual neutropenia \\< 1 x 109/L with or without complete platelet recovery. Red blood cell count (RBC) and platelet transfusion independence is not required.\n * The maximum time allowed from establishment of CR1 to registration is 12 months.\n* Participant has presence of the FLT3/ITD activating mutation in the BM or PB as determined by the local institution at diagnosis.\n* Participant must meet the following criteria as indicated on the clinical laboratory tests:\n\n * Serum creatinine within normal range, or if serum creatinine outside normal range, then glomerular filtration rate (GFR) \\> 40 mL/min/1.73m2 as calculated with the Cockcroft-Gault equation with adjustment if total body weight is ≥ 125% of ideal body weight.\n * Total bilirubin (TBL) ≤ 2.5 mg/dL, except for participants with Gilbert\'s syndrome.\n * Serum AST and/or alanine aminotransferase (ALT) \\< 3 x institutional upper limit of normal (ULN).\n* Participant has left ventricular ejection fraction at rest ≥ 40%.\n* Participant has diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) ≥ 50% predicted and/or forced expiratory volume in 1 second (FEV1) ≥ 50% predicted.\n* Female participants must either:\n\n * Be of non-childbearing potential:\n * postmenopausal (defined as at least 1 year without menses) prior to screening or\n * documented as surgically sterilized (at least 1 month prior to the screening visit)\n* Or, if of childbearing potential,\n\n * Agree not to try to become pregnant during the study for 6 months after the final study drug administration\n * And have a negative serum pregnancy test at screening\n * And, if heterosexually active, agree to consistently use highly effective contraception per locally accepted standards in addition to a barrier method starting at screening and throughout the study period and for 6 months after the final study drug administration.\n * For United Kingdom sites:\n * Highly effective forms of birth control include:\n * Consistent and correct usage of established hormonal contraceptives that inhibit ovulation\n * Established intrauterine device (IUD) or intrauterine system (IUS)\n* Female participants must agree not to breastfeed or donate ova throughout the study drug treatment period and for 6 months after the final study drug administration.\n* Male participants (even if surgically sterilized), and partners who are women of childbearing potential must be using highly effective contraception in addition to a barrier method throughout the study drug treatment period and for 127 days after the final study drug administration.\n\n * For United Kingdom sites:\n * Highly effective forms of birth control include:\n * Consistent and correct usage of established hormonal contraceptives that inhibit ovulation\n * Established IUD or IUS\n * Vasectomy (A vasectomy is a highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.)\n * Male is sterile due to a bilateral orchiectomy\n* Male participants must not donate sperm throughout the study drug treatment period and for 127 days after the final study drug administration.\n* Participant is able to take an oral medication.\n* Participant agrees not to participate in another interventional study while on treatment.\n\nRandomization Inclusion Criteria\n\n* Participant is ≥ 30 days and ≤ 90 days from hematopoietic cell infusion.\n* Participant has achieved engraftment. Engraftment is defined as ANC ≥ 500 cells/μL and platelets ≥ 20000/μL on 3 consecutive measurements (each occurring at least 1 day apart). The participant must not have had a platelet transfusion within 7 days prior to the first measurement.\n* Participant has confirmed ongoing morphologically documented AML in CR1. For the purposes of randomization, CR1 will be defined as \\< 5% blasts with no morphologic characteristics of acute leukemia (e.g., Auer Rods) in the BM with no evidence of extramedullary disease such as central nervous system involvement or granulocytic sarcoma.\n* Participant meets the following criteria as indicated on the clinical laboratory tests:\n\n * Serum creatinine within normal range, or if serum creatinine outside normal range, then GFR \\> 40 mL/min/1.73m2 as calculated with the Cockcroft-Gault equation with adjustment if total body weight is ≥ 125% of ideal body weight.\n * TBL \\< 2.5 mg/dL, except for participants with Gilbert\'s syndrome.\n * Serum AST and/or ALT \\< 3 x institutional ULN.\n * Serum potassium and magnesium ≥ the institutional lower limit of normal (LLN).\n* If the participant has developed overall grades II-IV acute GVHD, the following criteria must be met to be randomized:\n\n * No requirement of \\> 0.5 mg/kg of prednisone (or equivalent) daily dose within 1 week of randomization\n * No escalation of systemic immunosuppression in terms of increase of corticosteroids or addition of new agent / modality within 2 weeks of randomization. (Note that increasing calcineurin inhibitors or sirolimus to achieve therapeutic trough levels is allowed.) Topical skin and topical gastrointestinal steroids are allowed.\n* Participant is able to take oral medication.\n\nRegistration Exclusion Criteria\n\n* Participant has had a prior allogeneic transplant.\n* Participant has Karnofsky performance status score \\< 70% .\n* Participant requires treatment with concomitant drugs that are strong inducers of CYP3A within 14 days of start of study drug.\n* Participant requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the participant.\n* Participant has a Fridericia-corrected QT interval (QTcF) \\> 450 msec (average of triplicate determinations) per central read.\n* Participant has long QT Syndrome at screening.\n* Participant has a known infection with human immunodeficiency virus (HIV).\n* Participant has active hepatitis B infection as determined by NAAT or surface antigen assay. Participants who have acquired immunity from past exposure (HBcAb positive / HBsAb positive / HBsAg negative) are eligible.\n* Participant has active hepatitis C infection as determined by NAAT. NAAT must be performed if the participant has positive serology for hepatitis C. Participants who have had past exposure and have no detectable virus either through spontaneous clearance or treatment are eligible.\n* Participant has an uncontrolled infection. If a bacterial or viral infection is present, the participant must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to registration. If a fungal infection is present, the participant must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to registration.\n\n * Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection.\n * Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n* Participant has had a myocardial infarction within 6 months prior to registration or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.\n* Participant has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.\n* Participant is breast feeding or pregnant.\n* Participant has prior malignancies, except lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ.\n\nCancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent \\< 5 years previously will not be allowed.\n\nRandomization Exclusion Criteria\n\n* Participant requires treatment with concomitant drugs that are strong inducers of CYP3A within 14 days of starting study drug.\n* Participant requires treatment with concomitant drugs that target serotonin 5HT1R or 5HT2BR or sigma nonspecific receptor with the exception of drugs that are considered by the investigator to be absolutely essential for the care of the participant and for which no acceptable alternative exists.\n* Participant has a QTcF interval \\> 450 msec (average of triplicate determinations) by central read.\n* Participant has a need for supplemental oxygen with the exception of using previously existing non-invasive continuous positive airway pressure (CPAP) at night.\n* Participant has used investigational agents within 4 weeks of randomization.\n* Participant has used experimental therapy for acute GVHD within 4 weeks of randomization. If unsure of the definition of "experimental", discussion with one of the protocol chairs is recommended.\n* Participant has an uncontrolled infection. If a bacterial or viral infection is present, the participant must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to randomization. If a fungal infection is present, the participant must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to randomization.\n\n * Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection.\n * Persisting fever without other signs or symptoms will not be interpreted as progressing infection.'}, 'identificationModule': {'nctId': 'NCT02997202', 'briefTitle': 'A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML', 'orgStudyIdInfo': {'id': '2215-CL-0304'}, 'secondaryIdInfos': [{'id': '2016-001061-83', 'type': 'EUDRACT_NUMBER'}, {'id': 'BMT CTN 1506', 'type': 'OTHER', 'domain': 'Blood and Marrow Transplant Clinical Trials Network'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gilteritinib', 'description': 'Participants received gilteritinib 120 milligrams (mg) (three tablets of 40 mg) orally, once daily (QD) for up to 2 years or until a protocol-defined discontinuation criterion was met.', 'interventionNames': ['Drug: gilteritinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'gilteritinib', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['Gilteritinib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Virginia G Piper Cancer Center', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. 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