Viewing Study NCT02014558

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Ignite Creation Date: 2025-12-25 @ 12:15 AM
Ignite Modification Date: 2026-02-25 @ 10:05 PM
Study NCT ID: NCT02014558
Status: COMPLETED
Last Update Posted: 2024-12-03
First Post: 2013-11-06
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609080', 'term': 'gilteritinib'}, {'id': 'D065819', 'term': 'Voriconazole'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D002506', 'term': 'Cephalexin'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astellas.resultsdisclosure@astellas.com', 'phone': '800-888-7704', 'title': 'Clinical Trial Disclosure', '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': 'From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'The total number of deaths (all causes) includes deaths reported after the time frame above.', 'eventGroups': [{'id': 'EG000', 'title': 'Gilterinib 20 mg in Escalation Phase', 'description': 'Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 4, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Gilterinib 40 mg in Escalation Phase', 'description': 'Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Gilterinib 80 mg in Escalation Phase', 'description': 'Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Gilterinib 120 mg in Escalation Phase', 'description': 'Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Gilterinib 200 mg in Escalation Phase', 'description': 'Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Gilterinib 300 mg in Escalation Phase', 'description': 'Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Gilterinib 450 mg in Escalation Phase', 'description': 'Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'Gilterinib 20 mg in Expansion Phase', 'description': 'Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 10, 'seriousNumAffected': 8}, {'id': 'EG008', 'title': 'Gilterinib 40 mg in Expansion Phase', 'description': 'Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 12, 'seriousNumAtRisk': 13, 'deathsNumAffected': 13, 'seriousNumAffected': 12}, {'id': 'EG009', 'title': 'Gilterinib 80 mg in Expansion Phase', 'description': 'Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 20, 'seriousNumAtRisk': 21, 'deathsNumAffected': 21, 'seriousNumAffected': 19}, {'id': 'EG010', 'title': 'Gilterinib 120 mg in Expansion Phase', 'description': 'Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 62, 'seriousNumAtRisk': 66, 'deathsNumAffected': 53, 'seriousNumAffected': 52}, {'id': 'EG011', 'title': 'Gilterinib 200 mg in Expansion Phase', 'description': 'Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 97, 'seriousNumAtRisk': 100, 'deathsNumAffected': 82, 'seriousNumAffected': 92}, {'id': 'EG012', 'title': 'Gilterinib 300 mg in Expansion Phase', 'description': 'Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 16, 'seriousNumAtRisk': 17, 'deathsNumAffected': 16, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 84, 'numAffected': 27}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 65, 'numAffected': 33}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Hyperfibrinogenaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 28, 'numAffected': 5}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 29, 'numAffected': 12}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 27, 'numAffected': 12}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 44, 'numAffected': 19}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 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0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Phlebitis deep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}, {'value': '62', 'groupId': 'OG010'}, {'value': '87', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg in Escalation Phase', 'description': 'Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg in Escalation Phase', 'description': 'Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg in Escalation Phase', 'description': 'Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg in Escalation Phase', 'description': 'Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg in Escalation Phase', 'description': 'Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg in Escalation Phase', 'description': 'Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg in Escalation Phase', 'description': 'Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG007', 'title': 'Gilteritinib 20 mg in Expansion Phase', 'description': 'Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.'}, {'id': 'OG008', 'title': 'Gilteritinib 40 mg in Expansion Phase', 'description': 'Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.'}, {'id': 'OG009', 'title': 'Gilteritinib 80 mg in Expansion Phase', 'description': 'Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.'}, {'id': 'OG010', 'title': 'Gilteritinib 120 mg in Expansion Phase', 'description': 'Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.'}, {'id': 'OG011', 'title': 'Gilteritinib 200 mg in Expansion Phase', 'description': 'Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.'}, {'id': 'OG012', 'title': 'Gilteritinib 300 mg in Expansion Phase', 'description': 'Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.'}], 'classes': [{'title': 'Any DLT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}]}, {'title': 'Blood and lymphatic system disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}, {'title': 'Cardiac disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Eye disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Gastrointestinal disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}, {'title': 'General disorders & administration site conditions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Hepatobiliary disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}]}, {'title': 'Metabolism and nutrition disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Musculoskeletal and connective tissue disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}, {'title': 'Nervous system disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Renal and urinary disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Reproductive system and breast disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Respiratory, thoracic and mediastinal disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}, {'title': 'Vascular disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to end of cycle 1 (30 days)', 'description': 'To determine the maximum tolerated dose, safety was assessed by DLTs, defined as any grade ≥ 3 non-hematologic or extramedullary toxicity that occurred within 30 days starting with the first dose taken on day -2, and included the first treatment cycle in the dose escalation phase and in the first treatment cycle (28 days) in the dose expansion phase, that was considered to be possibly or probably related to study drug. Exceptions to this were the following: (1) Alopecia, anorexia or fatigue, (2) Grade 3 nausea and/or vomiting if not required tube feeding or total parenteral nutrition, or diarrhea if not required or prolonged hospitalization that was managed to grade ≤ 2 with standard antiemetic or antidiarrheal medications used at prescribed dose within 7 days of onset, (3) Grade 3 fever with neutropenia, with or without infection, (4) Grade 3 infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the SAF. Only evaluable participants (defined as participants who received at least 80% of the intended dose during cycle 1 \\[received at least 23 daily doses in escalation phase or 22 daily doses in expansion phase during cycle 1\\] or participants who developed DLT within cycle 1) were included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '21', 'groupId': 'OG009'}, {'value': '66', 'groupId': 'OG010'}, {'value': '100', 'groupId': 'OG011'}, {'value': '17', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg in Escalation Phase', 'description': 'Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg in Escalation Phase', 'description': 'Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg in Escalation Phase', 'description': 'Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg in Escalation Phase', 'description': 'Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg in Escalation Phase', 'description': 'Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg in Escalation Phase', 'description': 'Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg in Escalation Phase', 'description': 'Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG007', 'title': 'Gilteritinib 20 mg in Expansion Phase', 'description': 'Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.'}, {'id': 'OG008', 'title': 'Gilteritinib 40 mg in Expansion Phase', 'description': 'Participants received 40 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.'}, {'id': 'OG009', 'title': 'Gilteritinib 80 mg in Expansion Phase', 'description': 'Participants received 80 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.'}, {'id': 'OG010', 'title': 'Gilteritinib 120 mg in Expansion Phase', 'description': 'Participants received 120 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.'}, {'id': 'OG011', 'title': 'Gilteritinib 200 mg in Expansion Phase', 'description': 'Participants received 200 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.'}, {'id': 'OG012', 'title': 'Gilteritinib 300 mg in Expansion Phase', 'description': 'Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '64', 'groupId': 'OG010'}, {'value': '100', 'groupId': 'OG011'}, {'value': '17', 'groupId': 'OG012'}]}]}, {'title': 'Drug-Related AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}, {'value': '52', 'groupId': 'OG010'}, {'value': '77', 'groupId': 'OG011'}, {'value': '13', 'groupId': 'OG012'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '23', 'groupId': 'OG010'}, {'value': '49', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}]}]}, {'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}, {'value': '52', 'groupId': 'OG010'}, {'value': '92', 'groupId': 'OG011'}, {'value': '14', 'groupId': 'OG012'}]}]}, {'title': 'Drug-Related Serious AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '19', 'groupId': 'OG010'}, {'value': '36', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}]}]}, {'title': 'AEs Leading to Discontinuation of Study Drug', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '46', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}]}, {'title': 'Drug-Related AEs Leading to Discont. of Study Drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}]}, {'title': 'Grade 3 or Higher TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '59', 'groupId': 'OG010'}, {'value': '99', 'groupId': 'OG011'}, {'value': '14', 'groupId': 'OG012'}]}]}, {'title': 'AEs During On-Study HSCT Period', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Serious AEs During On-Study HSCT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug up to 30 days after last dose of study drug (for participants who underwent hematopoietic stem cell transplantation \\[HSCT\\]: defined as AEs observed after starting study drug until the last dose before on study HSCT plus 30 days, and AEs that began after resumption of gilteritinib and within 30 days after the last dose of gilteritinib). AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (1-Mild, 2-Moderate, 3-Severe, 4-LifeThreatening, 5-Death).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the SAF.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve Over the 24-Hour Dosing Interval (AUC24) After Single and Multiple Doses of Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg in Escalation Phase', 'description': 'Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg in Escalation Phase', 'description': 'Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg in Escalation Phase', 'description': 'Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg in Escalation Phase', 'description': 'Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg in Escalation Phase', 'description': 'Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg in Escalation Phase', 'description': 'Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg in Escalation Phase', 'description': 'Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}], 'classes': [{'title': 'Day -2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '302.1', 'spread': '207.0', 'groupId': 'OG000'}, {'value': '360.0', 'spread': '223.5', 'groupId': 'OG001'}, {'value': '1216', 'spread': '472.6', 'groupId': 'OG002'}, {'value': '2480', 'spread': '1972', 'groupId': 'OG003'}, {'value': '3022', 'spread': '843.6', 'groupId': 'OG004'}, {'value': '4163', 'spread': '3178', 'groupId': 'OG005'}, {'value': '3324', 'spread': '221.1', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1299', 'spread': '1006', 'groupId': 'OG000'}, {'value': '2482', 'spread': '33.28', 'groupId': 'OG001'}, {'value': '6958', 'spread': '3273', 'groupId': 'OG002'}, {'value': '6943', 'spread': '3221', 'groupId': 'OG003'}, {'value': '31428', 'spread': '21412', 'groupId': 'OG004'}, {'value': '31005', 'spread': '10068', 'groupId': 'OG005'}, {'value': '34768', 'spread': 'NA', 'comment': 'This cannot be calculated due to insufficient data (only 1 participant had available data).', 'groupId': 'OG006'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.990', 'ciLowerLimit': '0.788', 'ciUpperLimit': '1.19', 'groupDescription': 'Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.22', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.43', 'groupDescription': 'Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis set (PKAS) - consisted of the subset of the SAF for which sufficient plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of dosing on the day of sampling was known. Participants with available data were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Maximum Concentration (Cmax) After Single and Multiple Doses of Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg in Escalation Phase', 'description': 'Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study..'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg in Escalation Phase', 'description': 'Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study..'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg in Escalation Phase', 'description': 'Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg in Escalation Phase', 'description': 'Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg in Escalation Phase', 'description': 'Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg in Escalation Phase', 'description': 'Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg in Escalation Phase', 'description': 'Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}], 'classes': [{'title': 'Day -2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '28.13', 'spread': '21.49', 'groupId': 'OG000'}, {'value': '24.98', 'spread': '14.58', 'groupId': 'OG001'}, {'value': '75.29', 'spread': '25.22', 'groupId': 'OG002'}, {'value': '136.7', 'spread': '94.37', 'groupId': 'OG003'}, {'value': '168.2', 'spread': '45.34', 'groupId': 'OG004'}, {'value': '204.3', 'spread': '136.4', 'groupId': 'OG005'}, {'value': '207.6', 'spread': '51.81', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '64.64', 'spread': '48.77', 'groupId': 'OG000'}, {'value': '107.6', 'spread': '31.92', 'groupId': 'OG001'}, {'value': '376.4', 'spread': '150.5', 'groupId': 'OG002'}, {'value': '374.2', 'spread': '190.1', 'groupId': 'OG003'}, {'value': '1462', 'spread': '815.1', 'groupId': 'OG004'}, {'value': '1525', 'spread': '664.6', 'groupId': 'OG005'}, {'value': '1528', 'spread': 'NA', 'comment': 'This cannot be calculated due to insufficient data (only 1 participant had available data).', 'groupId': 'OG006'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.808', 'ciLowerLimit': '0.629', 'ciUpperLimit': '0.988', 'groupDescription': 'Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.21', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.41', 'groupDescription': 'Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS with available data.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) After Single and Multiple Doses of Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg in Escalation Phase', 'description': 'Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg in Escalation Phase', 'description': 'Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg in Escalation Phase', 'description': 'Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg in Escalation Phase', 'description': 'Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg in Escalation Phase', 'description': 'Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg in Escalation Phase', 'description': 'Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg in Escalation Phase', 'description': 'Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}], 'classes': [{'title': 'Day -2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '303.0', 'spread': '207.1', 'groupId': 'OG000'}, {'value': '360.4', 'spread': '224.1', 'groupId': 'OG001'}, {'value': '1216', 'spread': '472.6', 'groupId': 'OG002'}, {'value': '2480', 'spread': '1972', 'groupId': 'OG003'}, {'value': '3024', 'spread': '846.2', 'groupId': 'OG004'}, {'value': '4181', 'spread': '3189', 'groupId': 'OG005'}, {'value': '2544', 'spread': '1427', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 day -15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1030', 'spread': '984.2', 'groupId': 'OG000'}, {'value': '1990', 'spread': '1422', 'groupId': 'OG001'}, {'value': '7111', 'spread': '3525', 'groupId': 'OG002'}, {'value': '6943', 'spread': '3221', 'groupId': 'OG003'}, {'value': '32248', 'spread': '22571', 'groupId': 'OG004'}, {'value': '31749', 'spread': '10090', 'groupId': 'OG005'}, {'value': '35506', 'spread': 'NA', 'comment': 'This cannot be calculated due to insufficient data (only 1 participant had available data).', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS with available data.'}, {'type': 'PRIMARY', 'title': 'Time to Observed Cmax (Tmax) After Single and Multiple Doses of Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg in Escalation Phase', 'description': 'Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg in Escalation Phase', 'description': 'Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg in Escalation Phase', 'description': 'Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg in Escalation Phase', 'description': 'Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg in Escalation Phase', 'description': 'Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg in Escalation Phase', 'description': 'Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg in Escalation Phase', 'description': 'Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}], 'classes': [{'title': 'Day -2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '4.03'}, {'value': '5.983', 'groupId': 'OG001', 'lowerLimit': '3.97', 'upperLimit': '24.0'}, {'value': '4.000', 'groupId': 'OG002', 'lowerLimit': '4.00', 'upperLimit': '4.08'}, {'value': '2.083', 'groupId': 'OG003', 'lowerLimit': '2.00', 'upperLimit': '3.83'}, {'value': '5.233', 'groupId': 'OG004', 'lowerLimit': '4.00', 'upperLimit': '5.97'}, {'value': '6.067', 'groupId': 'OG005', 'lowerLimit': '4.08', 'upperLimit': '24.1'}, {'value': '5.783', 'groupId': 'OG006', 'lowerLimit': '4.08', 'upperLimit': '5.92'}]}]}, {'title': 'Cycle 1 day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4.008', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '6.00'}, {'value': '3.867', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '6.00'}, {'value': '4.333', 'groupId': 'OG002', 'lowerLimit': '4.00', 'upperLimit': '4.42'}, {'value': '2.167', 'groupId': 'OG003', 'lowerLimit': '1.95', 'upperLimit': '5.75'}, {'value': '6.033', 'groupId': 'OG004', 'lowerLimit': '6.00', 'upperLimit': '6.07'}, {'value': '6.050', 'groupId': 'OG005', 'lowerLimit': '4.08', 'upperLimit': '6.07'}, {'value': '5.933', 'comment': 'This cannot be calculated due to insufficient data (only 1 participant had available data).', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS with available data.'}, {'type': 'PRIMARY', 'title': 'Terminal Elimination Half-life (t1/2) After Multiple Doses of Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg in Escalation Phase', 'description': 'Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg in Escalation Phase', 'description': 'Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg in Escalation Phase', 'description': 'Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg in Escalation Phase', 'description': 'Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg in Escalation Phase', 'description': 'Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg in Escalation Phase', 'description': 'Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg in Escalation Phase', 'description': 'Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.14', 'spread': '17.88', 'groupId': 'OG000'}, {'value': '151.8', 'spread': '129.2', 'groupId': 'OG001'}, {'value': '86.11', 'spread': '24.08', 'groupId': 'OG002'}, {'value': '45.85', 'spread': '18.83', 'groupId': 'OG003'}, {'value': '141.9', 'spread': '61.51', 'groupId': 'OG004'}, {'value': '142.2', 'spread': '55.04', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS with available data.'}, {'type': 'PRIMARY', 'title': 'Accumulation Ratio After Multiple Doses of Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg in Escalation Phase', 'description': 'Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg in Escalation Phase', 'description': 'Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg in Escalation Phase', 'description': 'Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg in Escalation Phase', 'description': 'Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg in Escalation Phase', 'description': 'Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg in Escalation Phase', 'description': 'Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg in Escalation Phase', 'description': 'Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in in the escalation phase of the study.28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.259', 'spread': '1.069', 'groupId': 'OG000'}, {'value': '9.640', 'spread': '7.754', 'groupId': 'OG001'}, {'value': '5.693', 'spread': '1.442', 'groupId': 'OG002'}, {'value': '3.290', 'spread': '1.118', 'groupId': 'OG003'}, {'value': '9.041', 'spread': '3.693', 'groupId': 'OG004'}, {'value': '9.057', 'spread': '3.303', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS with available data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Remission (CR) During the First 2 Cycles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '38.5'}, {'value': '3.6', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '12.3'}, {'value': '3.4', 'groupId': 'OG004', 'lowerLimit': '0.7', 'upperLimit': '9.5'}, {'value': '10', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '30.2'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.2', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '21.1'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '9.9'}, {'value': '3.0', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '8.5'}, {'value': '5.0', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '24.9'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the first 2 cycles (56 days)', 'description': 'CR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CR when they had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an absolute neutrophil count (ANC) \\> 1 x 10\\^9/L, platelet count ≥ 100 x 10\\^9/L, normal marrow differential with \\< 5% blasts, had been red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion), had no presence of Auer rods and no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Exact 95% confidence interval was estimated using binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set (FAS) - consisted of all participants who were enrolled, took at least 1 dose of study drug and who had at least 1 posttreatment data point. Re-enrolled participants and participants from one site due to concerns with this site's GCP compliance were excluded. Participants were summarized under planned reporting groups in the FAS."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CR During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16.7', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '48.4'}, {'value': '12.5', 'groupId': 'OG003', 'lowerLimit': '5.2', 'upperLimit': '24.1'}, {'value': '11.2', 'groupId': 'OG004', 'lowerLimit': '5.5', 'upperLimit': '19.7'}, {'value': '10.0', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '30.2'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '27.0'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '4.1', 'upperLimit': '19.5'}, {'value': '10.0', 'groupId': 'OG004', 'lowerLimit': '4.9', 'upperLimit': '17.6'}, {'value': '5.0', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '54.9'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'CR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CR when they had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an absolute neutrophil count (ANC) \\> 1 x 10\\^9/L, platelet count ≥ 100 x 10\\^9/L, normal marrow differential with \\< 5% blasts, had been red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion), had no presence of Auer rods and no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Exact 95% confidence interval was estimated using binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CR With Incomplete Platelet Recovery (CRp)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.6', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '12.3'}, {'value': '9.0', 'groupId': 'OG004', 'lowerLimit': '4.0', 'upperLimit': '16.9'}, {'value': '10.0', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '9.9'}, {'value': '8.0', 'groupId': 'OG004', 'lowerLimit': '3.5', 'upperLimit': '15.2'}, {'value': '5.0', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '24.9'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'CRp was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRp when they achieved CR except for incomplete platelet recovery (\\< 100 x 10\\^9/L). Exact 95% confidence interval was estimated using the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CR With Incomplete Hematological Recovery (CRi)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '5.5', 'upperLimit': '57.2'}, {'value': '30.4', 'groupId': 'OG003', 'lowerLimit': '18.8', 'upperLimit': '44.1'}, {'value': '20.2', 'groupId': 'OG004', 'lowerLimit': '12.4', 'upperLimit': '30.1'}, {'value': '10.0', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16.7', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '48.4'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '9.1', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '41.3'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '30.2'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '20.8', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '42.2'}, {'value': '25.7', 'groupId': 'OG003', 'lowerLimit': '16.0', 'upperLimit': '37.6'}, {'value': '19.0', 'groupId': 'OG004', 'lowerLimit': '11.8', 'upperLimit': '28.1'}, {'value': '5.0', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '24.9'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'CRi was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRi when they fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia \\< 1 x 10\\^9/L with or without complete platelet recovery. RBC and platelet transfusion independence were not required. Exact 95% confidence interval was estimated using the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '38.5'}, {'value': '10.7', 'groupId': 'OG003', 'lowerLimit': '4.0', 'upperLimit': '21.9'}, {'value': '7.9', 'groupId': 'OG004', 'lowerLimit': '3.2', 'upperLimit': '15.5'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '55.6'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'CRh was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRh when they could not be classified as being in CR and had bone marrow blasts \\< 5% and partial hematologic recovery ANC \\>= 0.5 x 10\\^9/L and platelets \\>= 50 x 10\\^9/L. There should not be evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution. CRh was calculated only for participants who were FLT3 mutation positive.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS, with participants who were FLT3 mutation positive.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Composite CR (CRc)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '41.7', 'groupId': 'OG002', 'lowerLimit': '15.2', 'upperLimit': '72.3'}, {'value': '46.4', 'groupId': 'OG003', 'lowerLimit': '33.0', 'upperLimit': '60.3'}, {'value': '40.4', 'groupId': 'OG004', 'lowerLimit': '30.2', 'upperLimit': '51.4'}, {'value': '30.0', 'groupId': 'OG005', 'lowerLimit': '6.7', 'upperLimit': '65.2'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16.7', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '48.4'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '9.1', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '41.3'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '38.3'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '29.2', 'groupId': 'OG002', 'lowerLimit': '12.6', 'upperLimit': '51.1'}, {'value': '38.6', 'groupId': 'OG003', 'lowerLimit': '27.2', 'upperLimit': '51.0'}, {'value': '37.0', 'groupId': 'OG004', 'lowerLimit': '27.6', 'upperLimit': '47.2'}, {'value': '15.0', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '37.9'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'CRc was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRc when they had achieved either CR, complete remission with incomplete platelet recovery (CRp, defined as had achieved CR except for incomplete platelet recovery (\\< 100 x 10\\^9/L) or complete remission with incomplete hematologic recovery (CRi, defined as had fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia \\< 1 x 10\\^9/L with or without complete platelet recovery; RBC platelet transfusion independence not required). Exact 95% confidence interval was estimated using the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Partial Remission (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '37.5', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '75.5'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '5.5', 'upperLimit': '57.2'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '17.3'}, {'value': '7.9', 'groupId': 'OG004', 'lowerLimit': '3.2', 'upperLimit': '15.5'}, {'value': '30.0', 'groupId': 'OG005', 'lowerLimit': '6.7', 'upperLimit': '65.2'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '9.1', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '41.3'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '30.2'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '45.6'}, {'value': '12.5', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '32.4'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '2.4', 'upperLimit': '15.9'}, {'value': '8.0', 'groupId': 'OG004', 'lowerLimit': '3.5', 'upperLimit': '15.2'}, {'value': '15.0', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '37.9'}, {'value': '33.3', 'groupId': 'OG006', 'lowerLimit': '0.8', 'upperLimit': '90.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'PR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in PR when they had bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and with a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate with the total marrow blasts between 5% and 25%. A value of less or equal than 5% blasts was also considered a PR if Auer rods were present. There should be no evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Best Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '42.8'}, {'value': '37.5', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '75.5'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '34.9', 'upperLimit': '90.1'}, {'value': '53.6', 'groupId': 'OG003', 'lowerLimit': '39.7', 'upperLimit': '67.0'}, {'value': '48.3', 'groupId': 'OG004', 'lowerLimit': '37.6', 'upperLimit': '59.2'}, {'value': '60.0', 'groupId': 'OG005', 'lowerLimit': '26.2', 'upperLimit': '87.8'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16.7', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '48.4'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '1.8', 'upperLimit': '42.8'}, {'value': '18.2', 'groupId': 'OG004', 'lowerLimit': '2.3', 'upperLimit': '51.8'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '45.6'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '45.6'}, {'value': '41.7', 'groupId': 'OG002', 'lowerLimit': '22.1', 'upperLimit': '63.4'}, {'value': '45.7', 'groupId': 'OG003', 'lowerLimit': '33.7', 'upperLimit': '58.1'}, {'value': '45.0', 'groupId': 'OG004', 'lowerLimit': '35.0', 'upperLimit': '55.3'}, {'value': '30.0', 'groupId': 'OG005', 'lowerLimit': '11.9', 'upperLimit': '54.3'}, {'value': '33.3', 'groupId': 'OG006', 'lowerLimit': '0.8', 'upperLimit': '90.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'Best response was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). BR was defined as the best measured response for all visits (in the order of CR, CRp, CRi, and PR) post-treatment. Participants who achieved the best response of CR, CRp, CRi or PR were classified as responders. Participants who did not achieve at least PR were considered as non-responders. Exact 95% confidence interval was estimated using the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Remission and Complete Remission With Partial Hematologic Recovery (CR/CRh)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '5.5', 'upperLimit': '57.2'}, {'value': '23.2', 'groupId': 'OG003', 'lowerLimit': '13.0', 'upperLimit': '36.4'}, {'value': '19.1', 'groupId': 'OG004', 'lowerLimit': '11.5', 'upperLimit': '28.8'}, {'value': '30.0', 'groupId': 'OG005', 'lowerLimit': '6.7', 'upperLimit': '65.2'}, {'value': '0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'Participants with CR/CRh were defined as participants who achieved either CR or CRh. Participants with CR had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an ANC \\> 1 x 10\\^9/L, platelet count ≥ 100 x 10\\^9/L, and normal marrow differential with \\< 5% blasts, had been RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). Also, there had been no presence of Auer rods, no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Participants with CRh could not be classified as being in CR and had bone marrow blasts \\< 5%, partial hematologic recovery ANC \\>= 0.5 x 10\\^9/L and platelets \\>= 50 x 10\\^9/L. There should not be evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution. CR/CRh was calculated only for participants who were FLT3 mutation positive.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS, with participants who were FLT3 mutation positive.'}, {'type': 'SECONDARY', 'title': 'Duration of CR (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG003', 'lowerLimit': '86.0', 'upperLimit': 'NA'}, {'value': '419.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG004', 'lowerLimit': '64.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG003', 'lowerLimit': '86.0', 'upperLimit': 'NA'}, {'value': '419.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG004', 'lowerLimit': '64.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'DCR was defined as the time from the date of first CR until the date of documented relapse for participants who achieved CR. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study were considered non-events and censored at the last relapse-free disease assessment date. DCR was calculated using Kaplan-Meier method and therefore data are estimated.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Duration of CRp (DCRp)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG003', 'lowerLimit': '57.0', 'upperLimit': 'NA'}, {'value': '450.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG004', 'lowerLimit': '43.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG003', 'lowerLimit': '57.0', 'upperLimit': 'NA'}, {'value': '450.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG004', 'lowerLimit': '43.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'DCRp was defined as the time from the date of first CRp until the date of documented relapse for participants who achieved CRp. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study were considered non-events and censored at the last relapse-free disease assessment date. DCRp was calculated using Kaplan-Meier method and therefore data are estimated.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CRp were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Duration of CRi (DCRi)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': '79.0', 'upperLimit': 'NA'}, {'value': '120.0', 'groupId': 'OG003', 'lowerLimit': '56.0', 'upperLimit': '383.0'}, {'value': '191.0', 'groupId': 'OG004', 'lowerLimit': '57.0', 'upperLimit': '420.0'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG002', 'lowerLimit': '22.0', 'upperLimit': '60.0'}, {'value': '99.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '79.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': '22.0', 'upperLimit': 'NA'}, {'value': '120.0', 'groupId': 'OG003', 'lowerLimit': '58.0', 'upperLimit': '383.0'}, {'value': '191.0', 'groupId': 'OG004', 'lowerLimit': '57.0', 'upperLimit': '420.0'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'DCRi was defined as the time from the date of first CRi until the date of documented relapse for participants who achieved CRi. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRi was calculated using Kaplan-Meier method and therefore data are estimated.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CRi were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Duration of CRh (DCRh)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '64.0', 'groupId': 'OG003', 'lowerLimit': '18.0', 'upperLimit': '85.0'}, {'value': '101.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG004', 'lowerLimit': '29.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'DCRh was defined as the time from the date of first CRh until the date of documented relapse for participants who achieved CRh but did not have a best response of CR. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRh was calculated using Kaplan-Meier method and therefore data are estimated. DCRh was calculated only for participants who were FLT3 mutation positive.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CRh were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Duration of CRc (DCRc)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': '79.0', 'upperLimit': 'NA'}, {'value': '98.0', 'groupId': 'OG003', 'lowerLimit': '57.0', 'upperLimit': '307.0'}, {'value': '191.0', 'groupId': 'OG004', 'lowerLimit': '101.0', 'upperLimit': '465.0'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '41.0', 'groupId': 'OG002', 'lowerLimit': '22.0', 'upperLimit': '60.0'}, {'value': '99.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '79.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': '22.0', 'upperLimit': 'NA'}, {'value': '99.0', 'groupId': 'OG003', 'lowerLimit': '58.0', 'upperLimit': '307.0'}, {'value': '191.0', 'groupId': 'OG004', 'lowerLimit': '101.0', 'upperLimit': '465.0'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'DCRc was defined as the time from the date of first CRc until the date of documented relapse for participants who achieved CRc. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRc was calculated using Kaplan-Meier method and therefore data are estimated.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CRc were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Duration of CR/CRh (DCRCRh)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '307.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG003', 'lowerLimit': '56.0', 'upperLimit': 'NA'}, {'value': '308.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG004', 'lowerLimit': '101.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'DCRCRh was defined as the time from the date of first DCRCRh until the date of documented relapse for participants who achieved CR or CRh. For participants who achieved both CR and CRh, the first CR date or CRh date, whichever occurred first, was used. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRCRh was calculated using Kaplan-Meier method and therefore data are estimated. DCRCRh was calculated only for participants who were FLT3 mutation positive.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CR or CRh were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '88.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': 'NA'}, {'value': '141.0', 'groupId': 'OG003', 'lowerLimit': '58.0', 'upperLimit': '383.0'}, {'value': '220.0', 'groupId': 'OG004', 'lowerLimit': '111.0', 'upperLimit': '482.0'}, {'value': '59.0', 'groupId': 'OG005', 'lowerLimit': '15.0', 'upperLimit': '59.0'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '41.0', 'groupId': 'OG002', 'lowerLimit': '22.0', 'upperLimit': '60.0'}, {'value': '109.5', 'groupId': 'OG003', 'lowerLimit': '99.0', 'upperLimit': '120.0'}, {'value': '85.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '79.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': 'NA'}, {'value': '126.0', 'groupId': 'OG003', 'lowerLimit': '58.0', 'upperLimit': '307.0'}, {'value': '220.0', 'groupId': 'OG004', 'lowerLimit': '85.0', 'upperLimit': '482.0'}, {'value': '59.0', 'groupId': 'OG005', 'lowerLimit': '15.0', 'upperLimit': '59.0'}, {'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'Duration of response was defined as the time from the date of either first CRc or PR until the date of documented relapse of any type for participants who achieved CRc or PR. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study are considered non-events and censored at the last relapse-free assessment date. Duration of response was calculated using Kaplan-Meier method and therefore data are estimated.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CRc or PR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to CR (TTCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '171.5', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '315'}, {'value': '141.0', 'groupId': 'OG003', 'lowerLimit': '29', 'upperLimit': '364'}, {'value': '93.0', 'groupId': 'OG004', 'lowerLimit': '27', 'upperLimit': '225'}, {'value': '56.0', 'groupId': 'OG005', 'lowerLimit': '56', 'upperLimit': '56'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '30'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '30'}, {'value': '171.5', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '315'}, {'value': '141.0', 'groupId': 'OG003', 'lowerLimit': '29', 'upperLimit': '364'}, {'value': '93.0', 'groupId': 'OG004', 'lowerLimit': '27', 'upperLimit': '225'}, {'value': '56.0', 'groupId': 'OG005', 'lowerLimit': '56', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTCR was defined as the time from the first dose of study drug until the date of first CR.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to CRp (TTCRp)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '140.0', 'groupId': 'OG002', 'lowerLimit': '140', 'upperLimit': '140'}, {'value': '195.0', 'groupId': 'OG003', 'lowerLimit': '30', 'upperLimit': '418'}, {'value': '84.5', 'groupId': 'OG004', 'lowerLimit': '28', 'upperLimit': '392'}, {'value': '29.0', 'groupId': 'OG005', 'lowerLimit': '28', 'upperLimit': '30'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '140.0', 'groupId': 'OG002', 'lowerLimit': '140', 'upperLimit': '140'}, {'value': '195.0', 'groupId': 'OG003', 'lowerLimit': '30', 'upperLimit': '418'}, {'value': '84.5', 'groupId': 'OG004', 'lowerLimit': '28', 'upperLimit': '392'}, {'value': '29.0', 'groupId': 'OG005', 'lowerLimit': '28', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTCRp was defined as the time from the first dose of study drug until the date of first CRp. TTCRp was evaluated for participants who achieved CRp.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CRp were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to CRi (TTCRi)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '57'}, {'value': '57.0', 'groupId': 'OG002', 'lowerLimit': '31', 'upperLimit': '70'}, {'value': '57.0', 'groupId': 'OG003', 'lowerLimit': '26', 'upperLimit': '170'}, {'value': '39.5', 'groupId': 'OG004', 'lowerLimit': '26', 'upperLimit': '133'}, {'value': '28.0', 'groupId': 'OG005', 'lowerLimit': '28', 'upperLimit': '28'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG002', 'lowerLimit': '71', 'upperLimit': '72'}, {'value': '30.0', 'groupId': 'OG003', 'lowerLimit': '30', 'upperLimit': '30'}, {'value': '30.0', 'groupId': 'OG004', 'lowerLimit': '30', 'upperLimit': '30'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '57'}, {'value': '64.0', 'groupId': 'OG002', 'lowerLimit': '31', 'upperLimit': '72'}, {'value': '43.5', 'groupId': 'OG003', 'lowerLimit': '26', 'upperLimit': '170'}, {'value': '35.0', 'groupId': 'OG004', 'lowerLimit': '26', 'upperLimit': '133'}, {'value': '28.0', 'groupId': 'OG005', 'lowerLimit': '28', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTCRi was defined as the time from the first dose of study drug until the date of first CRi. TTCRi was evaluated for participants who achieved CRi.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CRi were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to First CR/CRh (TTFCRCRh)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '57'}, {'value': '57.0', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '140'}, {'value': '59.0', 'groupId': 'OG003', 'lowerLimit': '29', 'upperLimit': '280'}, {'value': '57.0', 'groupId': 'OG004', 'lowerLimit': '27', 'upperLimit': '245'}, {'value': '28.0', 'groupId': 'OG005', 'lowerLimit': '28', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTFCRCRh was defined as the time from the first dose of study drug until the date of first either CR or CRh. TTFCRCRh was evaluated for participants who achieved CR or CRh. For participants who achieve both CR and CRh, the first CR date or CRh date, whichever occurs first was used. TTFCRCRh was calculated only for participants who were FLT3 mutation positive.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CR or CRh were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Best CR/CRh (TTBCRCRh)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '57'}, {'value': '57.0', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '315'}, {'value': '63.0', 'groupId': 'OG003', 'lowerLimit': '29', 'upperLimit': '364'}, {'value': '88.0', 'groupId': 'OG004', 'lowerLimit': '27', 'upperLimit': '245'}, {'value': '30.0', 'groupId': 'OG005', 'lowerLimit': '28', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTBCRCRh was defined as the time from the first dose of study drug until the first date that the best response of CR or CRh was achieved. TTBCRCRh was evaluated for participants who achieved CR or CRh. For participants who achieve both CR and CRh, the first CR date was used. TTBCRCRh was calculated only for participants who were FLT3 mutation positive.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Participants who achieved CR or CRh were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to CRc (TTCRc)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '57'}, {'value': '56.0', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '64'}, {'value': '30.0', 'groupId': 'OG003', 'lowerLimit': '26', 'upperLimit': '211'}, {'value': '31.5', 'groupId': 'OG004', 'lowerLimit': '26', 'upperLimit': '197'}, {'value': '28.0', 'groupId': 'OG005', 'lowerLimit': '28', 'upperLimit': '30'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '30'}, {'value': '71.5', 'groupId': 'OG002', 'lowerLimit': '71', 'upperLimit': '72'}, {'value': '30.0', 'groupId': 'OG003', 'lowerLimit': '30', 'upperLimit': '30'}, {'value': '30.0', 'groupId': 'OG004', 'lowerLimit': '30', 'upperLimit': '30'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '43.5', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '57'}, {'value': '57.0', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '72'}, {'value': '30.0', 'groupId': 'OG003', 'lowerLimit': '26', 'upperLimit': '211'}, {'value': '31.0', 'groupId': 'OG004', 'lowerLimit': '26', 'upperLimit': '197'}, {'value': '28.0', 'groupId': 'OG005', 'lowerLimit': '28', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTCRc was defined as the time from the first dose of study drug until the date of first CRc. TTCRc was evaluated for participants who achieved CRc.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CRc were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '94'}, {'value': '57.0', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '64'}, {'value': '31.0', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '59'}, {'value': '29.0', 'groupId': 'OG003', 'lowerLimit': '26', 'upperLimit': '211'}, {'value': '29.0', 'groupId': 'OG004', 'lowerLimit': '26', 'upperLimit': '197'}, {'value': '28.0', 'groupId': 'OG005', 'lowerLimit': '26', 'upperLimit': '61'}, {'value': '31.0', 'groupId': 'OG006', 'lowerLimit': '31', 'upperLimit': '31'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '30'}, {'value': '71.5', 'groupId': 'OG002', 'lowerLimit': '71', 'upperLimit': '72'}, {'value': '29.5', 'groupId': 'OG003', 'lowerLimit': '29', 'upperLimit': '30'}, {'value': '29.5', 'groupId': 'OG004', 'lowerLimit': '29', 'upperLimit': '30'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '94'}, {'value': '57.0', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '64'}, {'value': '43.5', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '72'}, {'value': '29.0', 'groupId': 'OG003', 'lowerLimit': '26', 'upperLimit': '211'}, {'value': '29.0', 'groupId': 'OG004', 'lowerLimit': '26', 'upperLimit': '197'}, {'value': '28.0', 'groupId': 'OG005', 'lowerLimit': '26', 'upperLimit': '61'}, {'value': '31.0', 'groupId': 'OG006', 'lowerLimit': '31', 'upperLimit': '31'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTR was defined as the time from the first dose of study drug until the date of either first CRc or PR. TTR was evaluated for participants who achieved CRc or PR.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CRc or PR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Best Response (TTBR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '75.5', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '94'}, {'value': '57.0', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '64'}, {'value': '44.0', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '315'}, {'value': '43.5', 'groupId': 'OG003', 'lowerLimit': '26', 'upperLimit': '364'}, {'value': '57.0', 'groupId': 'OG004', 'lowerLimit': '26', 'upperLimit': '245'}, {'value': '29.0', 'groupId': 'OG005', 'lowerLimit': '26', 'upperLimit': '61'}, {'value': '31.0', 'groupId': 'OG006', 'lowerLimit': '31', 'upperLimit': '31'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '30'}, {'value': '71.5', 'groupId': 'OG002', 'lowerLimit': '71', 'upperLimit': '72'}, {'value': '29.5', 'groupId': 'OG003', 'lowerLimit': '29', 'upperLimit': '30'}, {'value': '29.5', 'groupId': 'OG004', 'lowerLimit': '29', 'upperLimit': '30'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '94'}, {'value': '57.0', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '64'}, {'value': '58.0', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '315'}, {'value': '30.0', 'groupId': 'OG003', 'lowerLimit': '26', 'upperLimit': '364'}, {'value': '56.0', 'groupId': 'OG004', 'lowerLimit': '26', 'upperLimit': '245'}, {'value': '29.0', 'groupId': 'OG005', 'lowerLimit': '26', 'upperLimit': '61'}, {'value': '31.0', 'groupId': 'OG006', 'lowerLimit': '31', 'upperLimit': '31'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTBR was defined as the time from the first dose of study drug until the first disease assessment date when participant achieved best response. TTBR was evaluated in participants who achieved best response of CR, CRp, CRi, or PR.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CR, CRp, CRi, or PR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '123.0', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '267.0'}, {'value': '199.5', 'groupId': 'OG001', 'lowerLimit': '56.0', 'upperLimit': '905.0'}, {'value': '197.5', 'groupId': 'OG002', 'lowerLimit': '61.0', 'upperLimit': '329.0'}, {'value': '246.0', 'groupId': 'OG003', 'lowerLimit': '190.0', 'upperLimit': '309.0'}, {'value': '214.0', 'groupId': 'OG004', 'lowerLimit': '126.0', 'upperLimit': '264.0'}, {'value': '157.0', 'groupId': 'OG005', 'lowerLimit': '20.0', 'upperLimit': '218.0'}, {'value': '204.0', 'groupId': 'OG006', 'lowerLimit': '51.0', 'upperLimit': '357.0'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': '227.0', 'upperLimit': 'NA'}, {'value': '71.5', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '180.0'}, {'value': '136.0', 'groupId': 'OG002', 'lowerLimit': '14.0', 'upperLimit': '314.0'}, {'value': '144.0', 'groupId': 'OG003', 'lowerLimit': '83.0', 'upperLimit': '195.0'}, {'value': '67.0', 'groupId': 'OG004', 'lowerLimit': '21.0', 'upperLimit': '336.0'}, {'value': '68.0', 'groupId': 'OG005', 'lowerLimit': '8.0', 'upperLimit': '249.0'}, {'value': '89.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '149.5', 'groupId': 'OG000', 'lowerLimit': '31.0', 'upperLimit': '267.0'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '55.0', 'upperLimit': '195.0'}, {'value': '154.0', 'groupId': 'OG002', 'lowerLimit': '74.0', 'upperLimit': '299.0'}, {'value': '216.0', 'groupId': 'OG003', 'lowerLimit': '161.0', 'upperLimit': '285.0'}, {'value': '176.0', 'groupId': 'OG004', 'lowerLimit': '124.0', 'upperLimit': '253.0'}, {'value': '128.5', 'groupId': 'OG005', 'lowerLimit': '36.0', 'upperLimit': '199.0'}, {'value': '89.0', 'groupId': 'OG006', 'lowerLimit': '51.0', 'upperLimit': '357.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)', 'description': 'The time from the date of first dose of study drug until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact. OS was calculated using Kaplan-Meier method and therefore data are estimated.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS.'}, {'type': 'SECONDARY', 'title': 'Event Free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '52.0', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '88.0'}, {'value': '109.0', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '357.0'}, {'value': '93.5', 'groupId': 'OG002', 'lowerLimit': '61.0', 'upperLimit': '127.0'}, {'value': '112.0', 'groupId': 'OG003', 'lowerLimit': '92.0', 'upperLimit': '143.0'}, {'value': '121.0', 'groupId': 'OG004', 'lowerLimit': '92.0', 'upperLimit': '155.0'}, {'value': '85.0', 'groupId': 'OG005', 'lowerLimit': '11.0', 'upperLimit': '157.0'}, {'value': '86.0', 'groupId': 'OG006', 'lowerLimit': '51.0', 'upperLimit': '121.0'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '58.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '39.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '67.0'}, {'value': '74.0', 'groupId': 'OG002', 'lowerLimit': '12.0', 'upperLimit': '131.0'}, {'value': '85.5', 'groupId': 'OG003', 'lowerLimit': '37.0', 'upperLimit': '126.0'}, {'value': '45.0', 'groupId': 'OG004', 'lowerLimit': '21.0', 'upperLimit': '113.0'}, {'value': '43.0', 'groupId': 'OG005', 'lowerLimit': '8.0', 'upperLimit': '83.0'}, {'value': '71.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '88.0'}, {'value': '55.5', 'groupId': 'OG001', 'lowerLimit': '38.0', 'upperLimit': '92.0'}, {'value': '76.0', 'groupId': 'OG002', 'lowerLimit': '61.0', 'upperLimit': '119.0'}, {'value': '108.0', 'groupId': 'OG003', 'lowerLimit': '90.0', 'upperLimit': '126.0'}, {'value': '118.0', 'groupId': 'OG004', 'lowerLimit': '88.0', 'upperLimit': '140.0'}, {'value': '65.0', 'groupId': 'OG005', 'lowerLimit': '20.0', 'upperLimit': '100.0'}, {'value': '71.0', 'groupId': 'OG006', 'lowerLimit': '51.0', 'upperLimit': '121.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)', 'description': 'EFS was defined as the time from the date of first dose of study drug until the date of documented relapse, treatment failure or death from any cause, whichever occurred first. For a participant with none of these events, EFS was censored at the date of last relapse-free disease assessment. A participant without post-treatment disease assessment was censored at randomization date. Treatment failure included those participants who discontinued the treatment due to "progressive disease" or "lack of efficacy" without a previous response of CR, CRp, CRi or PR. Treatment failure date referred to the start of new anti-leukemia therapy or the last treatment evaluation date when new anti-leukemia therapy date was not available. For participants who were censored, last relapse-free disease assessment date referred to the participant\'s last disease assessment date. EFS was calculated using Kaplan-Meier method and therefore data are estimated.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS.'}, {'type': 'SECONDARY', 'title': 'Leukemia Free Survival (LFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '242.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '98.0', 'groupId': 'OG002', 'lowerLimit': '56.0', 'upperLimit': '1126.0'}, {'value': '98.0', 'groupId': 'OG003', 'lowerLimit': '58.0', 'upperLimit': '187.0'}, {'value': '146.0', 'groupId': 'OG004', 'lowerLimit': '47.0', 'upperLimit': '247.0'}, {'value': '296.0', 'groupId': 'OG005', 'lowerLimit': '130.0', 'upperLimit': '462.0'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '41.0', 'groupId': 'OG002', 'lowerLimit': '22.0', 'upperLimit': '60.0'}, {'value': '99.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '38.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '242.0', 'comment': 'Data could not be calculated due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '79.0', 'groupId': 'OG002', 'lowerLimit': '22.0', 'upperLimit': '1126.0'}, {'value': '98.0', 'groupId': 'OG003', 'lowerLimit': '58.0', 'upperLimit': '187.0'}, {'value': '146.0', 'groupId': 'OG004', 'lowerLimit': '45.0', 'upperLimit': '247.0'}, {'value': '296.0', 'groupId': 'OG005', 'lowerLimit': '130.0', 'upperLimit': '462.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)', 'description': 'LFS was defined as the time from the date of first CRc until the date of documented relapse or death for participants who achieved CRc. For a participant who was not known to have relapsed or died, LFS was censored on the date of last relapse-free disease assessment date. LFS was calculated using Kaplan-Meier method and therefore data are estimated.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants who achieved CRc were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Transfusion Conversion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0', 'comment': 'No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '37.5', 'groupId': 'OG002', 'lowerLimit': '8.5', 'upperLimit': '75.5'}, {'value': '27.5', 'groupId': 'OG003', 'lowerLimit': '14.6', 'upperLimit': '43.9'}, {'value': '40.4', 'groupId': 'OG004', 'lowerLimit': '27.6', 'upperLimit': '54.2'}, {'value': 'NA', 'comment': 'No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12.5', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '52.7'}, {'value': '22.2', 'groupId': 'OG003', 'lowerLimit': '2.8', 'upperLimit': '60.0'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '4.3', 'upperLimit': '77.7'}, {'value': 'NA', 'comment': 'No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '7.3', 'upperLimit': '52.4'}, {'value': '26.5', 'groupId': 'OG003', 'lowerLimit': '14.9', 'upperLimit': '41.1'}, {'value': '39.7', 'groupId': 'OG004', 'lowerLimit': '27.6', 'upperLimit': '52.8'}, {'value': 'NA', 'comment': 'No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No data could be calculated due to the low number of participants who had evaluable transfusion status postbaseline.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (28 days prior to first dose until 28 days after the first dose) and postbaseline (from 29 days after first dose date until last dose date); median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days', 'description': 'Participants who achieved transfusion conversion were defined as the number of participants who were transfusion dependent at baseline period but became transfusion independent at post-baseline period divided by the total number of participants who were transfusion dependent at baseline period. Participants were considered baseline transfusion dependent if there were RBC or platelet transfusions within the baseline period. Participants were considered post-baseline transfusion independent if they were on treatment \\>=84 days, and if there was one consecutive 56 days without any RBC or platelet transfusion within post-baseline period. If participants were on treatment \\>28 days but \\<84 days, and there was no RBC or platelet transfusion within post-baseline period, or on treatment \\<=28 days, post-baseline transfusion status was not evaluable. Exact 95% confidence interval was estimated using the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Participants who were transfusion dependent at baseline and had evaluable post-baseline transfusion status were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Transfusion Maintenance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg', 'description': 'Participants received 20 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG001', 'title': 'Gilteritinib 40 mg', 'description': 'Participants received 40 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG002', 'title': 'Gilteritinib 80 mg', 'description': 'Participants received 80 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG003', 'title': 'Gilteritinib 120 mg', 'description': 'Participants received 120 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG004', 'title': 'Gilteritinib 200 mg', 'description': 'Participants received 200 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG005', 'title': 'Gilteritinib 300 mg', 'description': 'Participants received 300 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}, {'id': 'OG006', 'title': 'Gilteritinib 450 mg', 'description': 'Participants received 450 mg gilteritinib orally once on day -2, and starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation.'}], 'classes': [{'title': 'FLT3 Mutation Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '100'}, {'value': '75.0', 'groupId': 'OG003', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '80.0', 'groupId': 'OG004', 'lowerLimit': '44.4', 'upperLimit': '97.5'}, {'value': '100.0', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '100.0'}]}]}, {'title': 'FLT3 Mutation Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '90.6'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '57.1', 'groupId': 'OG003', 'lowerLimit': '18.4', 'upperLimit': '90.1'}, {'value': '80.0', 'groupId': 'OG004', 'lowerLimit': '44.4', 'upperLimit': '97.5'}, {'value': '100.0', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (28 days prior to first dose until 28 days after the first dose) and postbaseline (from 29 days after first dose date until last dose date); median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days', 'description': 'Participants who achieved transfusion maintenance were defined as the number of participants who were transfusion independent at baseline period and still maintained transfusion independent at post-baseline period divided by the total number of participants who were transfusion independent at baseline period.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Participants who were transfusion independent at baseline and had evaluable post-baseline transfusion status were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'AUC24 of Gilteritinib in Co-administration With Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg in Expansion Phase', 'description': 'Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '919.3', 'spread': 'NA', 'comment': 'SD could not be calculated due to a sample size of 1.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.'}, {'type': 'SECONDARY', 'title': 'Cmax of Gilteritinib in Co-administration With Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg in Expansion Phase', 'description': 'Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.79', 'spread': 'NA', 'comment': 'SD could not be calculated due to a sample size of 1.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.'}, {'type': 'SECONDARY', 'title': 'AUClast of Gilteritinib in Co-administration With Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg in Expansion Phase', 'description': 'Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '919.3', 'spread': 'NA', 'comment': 'SD could not be calculated due to a sample size of 1.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.'}, {'type': 'SECONDARY', 'title': 'Tmax of Gilteritinib in Co-administration With Voriconazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 20 mg in Expansion Phase', 'description': 'Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.08', 'groupId': 'OG000', 'lowerLimit': '2.08', 'upperLimit': '2.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.'}, {'type': 'SECONDARY', 'title': 'AUC24 of Midazolam Administered With and Without Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 300 mg in Expansion Phase', 'description': 'Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.'}], 'classes': [{'title': 'Midazolam Alone (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.55', 'spread': '57.70', 'groupId': 'OG000'}]}]}, {'title': 'Midazolam + Gilteritinib (Cycle 1 Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.56', 'spread': '65.84', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '109.46', 'ciLowerLimit': '49.82', 'ciUpperLimit': '240.48', 'groupDescription': 'Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of least squares (LS) means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.'}, {'type': 'SECONDARY', 'title': 'AUC24 of Metabolite 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 300 mg in Expansion Phase', 'description': 'Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.'}], 'classes': [{'title': 'Midazolam Alone (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.44', 'spread': '24.80', 'groupId': 'OG000'}]}]}, {'title': 'Midazolam + Gilteritinib (Cycle 1 Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.10', 'spread': '21.64', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Geometric LS Mean Ratio', 'ciPctValue': '90', 'paramValue': '149.90', 'ciLowerLimit': '74.88', 'ciUpperLimit': '300.06', 'groupDescription': 'Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam alone and 1-hydroxymidazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.'}, {'type': 'SECONDARY', 'title': 'Cmax of Midazolam Administered With and Without Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 300 mg in Expansion Phase', 'description': 'Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.'}], 'classes': [{'title': 'Midazolam Alone (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.68', 'spread': '8.923', 'groupId': 'OG000'}]}]}, {'title': 'Midazolam + Gilteritinib (Cycle 1 Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.45', 'spread': '9.452', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '111.64', 'ciLowerLimit': '69.54', 'ciUpperLimit': '179.25', 'groupDescription': 'Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.'}, {'type': 'SECONDARY', 'title': 'Cmax of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 300 mg in Expansion Phase', 'description': 'Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.'}], 'classes': [{'title': 'Midazolam Alone (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.562', 'spread': '2.858', 'groupId': 'OG000'}]}]}, {'title': 'Midazolam + Gilteritinib (Cycle 1 Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.053', 'spread': '3.158', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '123.47', 'ciLowerLimit': '72.41', 'ciUpperLimit': '210.52', 'groupDescription': 'Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam/midazolam alone and 1-hydroxymidazolam/midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.'}, {'type': 'SECONDARY', 'title': 'AUClast of Midazolam Administered With and Without Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 300 mg in Expansion Phase', 'description': 'Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.'}], 'classes': [{'title': 'Midazolam Alone (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.48', 'spread': '59.49', 'groupId': 'OG000'}]}]}, {'title': 'Midazolam + Gilteritinib (Cycle 1 Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.44', 'spread': '64.25', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.'}, {'type': 'SECONDARY', 'title': 'AUClast of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 300 mg in Expansion Phase', 'description': 'Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.'}], 'classes': [{'title': 'Midazolam Alone (Day -1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.05', 'spread': '24.70', 'groupId': 'OG000'}]}]}, {'title': 'Midazolam + Gilteritinib (Cycle 1 Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.58', 'spread': '22.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)', 'description': 'Plasma samples were used for pharmacokinetic assessments.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.'}, {'type': 'SECONDARY', 'title': 'Tmax of Midazolam Administered With and Without Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 300 mg in Expansion Phase', 'description': 'Participants received 300 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. 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Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'FG001', 'title': 'Gilteritinib 40 mg in Escalation Phase', 'description': 'Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'FG002', 'title': 'Gilteritinib 80 mg in Escalation Phase', 'description': 'Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'FG003', 'title': 'Gilteritinib 120 mg in Escalation Phase', 'description': 'Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'FG004', 'title': 'Gilteritinib 200 mg in Escalation Phase', 'description': 'Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'FG005', 'title': 'Gilteritinib 300 mg in Escalation Phase', 'description': 'Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'FG006', 'title': 'Gilteritinib 450 mg in Escalation Phase', 'description': 'Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'FG007', 'title': 'Gilteritinib 20 mg in Expansion Phase', 'description': 'Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.'}, {'id': 'FG008', 'title': 'Gilteritinib 40 mg in Expansion Phase', 'description': 'Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.'}, {'id': 'FG009', 'title': 'Gilteritinib 80 mg in Expansion Phase', 'description': 'Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.'}, {'id': 'FG010', 'title': 'Gilteritinib 120 mg in Expansion Phase', 'description': 'Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.'}, {'id': 'FG011', 'title': 'Gilteritinib 200 mg in Expansion Phase', 'description': 'Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.'}, {'id': 'FG012', 'title': 'Gilteritinib 300 mg in Expansion Phase', 'description': 'Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Re-enrolled participants (assigned to the 120 mg \\[1\\] \\& 200 mg \\[4\\] expansion groups) were excluded.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '11'}, {'groupId': 'FG008', 'numSubjects': '15'}, {'groupId': 'FG009', 'numSubjects': '21'}, {'groupId': 'FG010', 'numSubjects': '69'}, {'groupId': 'FG011', 'numSubjects': '102'}, {'groupId': 'FG012', 'numSubjects': '17'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'comment': 'A participant randomized to the 120 mg was treated with an initial dose of 20 mg by mistake.', 'groupId': 'FG007', 'numSubjects': '12'}, {'groupId': 'FG008', 'numSubjects': '13'}, {'groupId': 'FG009', 'numSubjects': '21'}, {'comment': 'A participant randomized to the 120 mg was treated with an initial dose of 20 mg by mistake.', 'groupId': 'FG010', 'numSubjects': '66'}, {'groupId': 'FG011', 'numSubjects': '100'}, {'groupId': 'FG012', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '11'}, {'groupId': 'FG008', 'numSubjects': '15'}, {'groupId': 'FG009', 'numSubjects': '21'}, {'groupId': 'FG010', 'numSubjects': '69'}, {'groupId': 'FG011', 'numSubjects': '102'}, {'groupId': 'FG012', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Never Received Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '21'}, {'groupId': 'FG012', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '19'}, {'groupId': 'FG012', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '16'}, {'groupId': 'FG011', 'numSubjects': '8'}, {'groupId': 'FG012', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '22'}, {'groupId': 'FG011', 'numSubjects': '31'}, {'groupId': 'FG012', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '6'}, {'groupId': 'FG011', 'numSubjects': '10'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '12'}, {'groupId': 'FG011', 'numSubjects': '11'}, {'groupId': 'FG012', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This dose-escalation/dose-expansion study was conducted in sites in the United States, France, Germany and Italy. The study had 7 dose-escalation cohorts with ≥3 participants enrolled at each dose level. Following escalation to the next dose cohort, additional participants were enrolled to the dose-expansion cohorts per protocol-specified criteria.', 'preAssignmentDetails': 'Participants with acute myeloid leukemia (AML) who relapsed after or were refractory to induction or salvage treatment were selected for this study. Five participants were re-enrolled into the dose-expansion cohorts as they discontinued treatment for reasons other than toxicity or disease progression, as long as they met the eligibility criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '21', 'groupId': 'BG009'}, {'value': '66', 'groupId': 'BG010'}, {'value': '100', 'groupId': 'BG011'}, {'value': '17', 'groupId': 'BG012'}, {'value': '252', 'groupId': 'BG013'}]}], 'groups': [{'id': 'BG000', 'title': 'Gilteritinib 20 mg in Escalation Phase', 'description': 'Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'BG001', 'title': 'Gilteritinib 40 mg in Escalation Phase', 'description': 'Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'BG002', 'title': 'Gilteritinib 80 mg in Escalation Phase', 'description': 'Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'BG003', 'title': 'Gilteritinib 120 mg in Escalation Phase', 'description': 'Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'BG004', 'title': 'Gilteritinib 200 mg in Escalation Phase', 'description': 'Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'BG005', 'title': 'Gilteritinib 300 mg in Escalation Phase', 'description': 'Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'BG006', 'title': 'Gilteritinib 450 mg in Escalation Phase', 'description': 'Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.'}, {'id': 'BG007', 'title': 'Gilteritinib 20 mg in Expansion Phase', 'description': 'Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.'}, {'id': 'BG008', 'title': 'Gilteritinib 40 mg in Expansion Phase', 'description': 'Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.'}, {'id': 'BG009', 'title': 'Gilteritinib 80 mg in Expansion Phase', 'description': 'Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.'}, {'id': 'BG010', 'title': 'Gilteritinib 120 mg in Expansion Phase', 'description': 'Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.'}, {'id': 'BG011', 'title': 'Gilteritinib 200 mg in Expansion Phase', 'description': 'Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.'}, {'id': 'BG012', 'title': 'Gilteritinib 300 mg in Expansion Phase', 'description': 'Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.'}, {'id': 'BG013', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '21', 'groupId': 'BG009'}, {'value': '66', 'groupId': 'BG010'}, {'value': '100', 'groupId': 'BG011'}, {'value': '17', 'groupId': 'BG012'}, {'value': '252', 'groupId': 'BG013'}]}], 'categories': [{'measurements': [{'value': '65.8', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '56.7', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '61', 'spread': '8.7', 'groupId': 'BG002'}, {'value': '61.7', 'spread': '6', 'groupId': 'BG003'}, {'value': '64', 'spread': '1', 'groupId': 'BG004'}, {'value': '55.3', 'spread': '25', 'groupId': 'BG005'}, {'value': '61.7', 'spread': '10.7', 'groupId': 'BG006'}, {'value': '59.3', 'spread': '15.6', 'groupId': 'BG007'}, {'value': '59.6', 'spread': '14', 'groupId': 'BG008'}, {'value': '56.3', 'spread': '18.1', 'groupId': 'BG009'}, {'value': '58.3', 'spread': '16.7', 'groupId': 'BG010'}, {'value': '59.8', 'spread': '14.6', 'groupId': 'BG011'}, {'value': '57.7', 'spread': '15.9', 'groupId': 'BG012'}, {'value': '59', 'spread': '15.1', 'groupId': 'BG013'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '21', 'groupId': 'BG009'}, {'value': '66', 'groupId': 'BG010'}, {'value': '100', 'groupId': 'BG011'}, {'value': '17', 'groupId': 'BG012'}, {'value': '252', 'groupId': 'BG013'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '37', 'groupId': 'BG010'}, {'value': '49', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '123', 'groupId': 'BG013'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '29', 'groupId': 'BG010'}, {'value': '51', 'groupId': 'BG011'}, {'value': '12', 'groupId': 'BG012'}, {'value': '129', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '21', 'groupId': 'BG009'}, {'value': '66', 'groupId': 'BG010'}, {'value': '100', 'groupId': 'BG011'}, {'value': '17', 'groupId': 'BG012'}, {'value': '252', 'groupId': 'BG013'}]}], 'categories': [{'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '16', 'groupId': 'BG013'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '14', 'groupId': 'BG009'}, {'value': '57', 'groupId': 'BG010'}, {'value': '91', 'groupId': 'BG011'}, {'value': '13', 'groupId': 'BG012'}, {'value': '213', 'groupId': 'BG013'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '7', 'groupId': 'BG013'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '16', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '21', 'groupId': 'BG009'}, {'value': '66', 'groupId': 'BG010'}, {'value': '100', 'groupId': 'BG011'}, {'value': '17', 'groupId': 'BG012'}, {'value': '252', 'groupId': 'BG013'}]}], 'categories': [{'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}, {'value': '62', 'groupId': 'BG010'}, {'value': '97', 'groupId': 'BG011'}, {'value': '17', 'groupId': 'BG012'}, {'value': '241', 'groupId': 'BG013'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '11', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Disease (AML)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '11', 'groupId': 'BG008'}, {'value': '17', 'groupId': 'BG009'}, {'value': '46', 'groupId': 'BG010'}, {'value': '77', 'groupId': 'BG011'}, {'value': '15', 'groupId': 'BG012'}, {'value': '194', 'groupId': 'BG013'}]}], 'categories': [{'measurements': [{'value': '19.70', 'spread': '24.62', 'groupId': 'BG000'}, {'value': '10.81', 'spread': '8.58', 'groupId': 'BG001'}, {'value': '62.46', 'spread': '6.97', 'groupId': 'BG002'}, {'value': '49.53', 'spread': '72.17', 'groupId': 'BG003'}, {'value': '9.46', 'spread': '2.23', 'groupId': 'BG004'}, {'value': '19.75', 'spread': 'NA', 'comment': 'Data could not be calculated as there is only one participant in this arm who had available data.', 'groupId': 'BG005'}, {'value': '7.21', 'spread': '4.27', 'groupId': 'BG006'}, {'value': '11.3', 'spread': '6.61', 'groupId': 'BG007'}, {'value': '10.53', 'spread': '11.22', 'groupId': 'BG008'}, {'value': '16.3', 'spread': '9.85', 'groupId': 'BG009'}, {'value': '12.65', 'spread': '11.33', 'groupId': 'BG010'}, {'value': '10.9', 'spread': '9.94', 'groupId': 'BG011'}, {'value': '12.09', 'spread': '17.76', 'groupId': 'BG012'}, {'value': '13.16', 'spread': '14.97', 'groupId': 'BG013'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The analysis population was the SAF, with participants with data available.'}, {'title': 'Local FLT3 Mutation Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '21', 'groupId': 'BG009'}, {'value': '66', 'groupId': 'BG010'}, {'value': '100', 'groupId': 'BG011'}, {'value': '17', 'groupId': 'BG012'}, {'value': '252', 'groupId': 'BG013'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '13', 'groupId': 'BG010'}, {'value': '10', 'groupId': 'BG011'}, {'value': '9', 'groupId': 'BG012'}, {'value': '58', 'groupId': 'BG013'}]}, {'title': 'Positive', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '53', 'groupId': 'BG010'}, {'value': '90', 'groupId': 'BG011'}, {'value': '8', 'groupId': 'BG012'}, {'value': '194', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis population was the safety analysis set (SAF), which consisted of all participants who received at least 1 dose of study drug and excluded re-enrolled participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-02', 'size': 2164779, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-12-18T15:49', 'hasProtocol': True}, {'date': '2017-09-20', 'size': 2298807, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-12-20T14:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 265}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03070093', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2024-10', 'dispFirstSubmitDate': '2016-11-16', 'completionDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2013-11-06', 'dispFirstSubmitQcDate': '2016-11-16', 'resultsFirstSubmitDate': '2018-12-19', 'studyFirstSubmitQcDate': '2013-12-12', 'dispFirstPostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-31', 'studyFirstPostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose Limiting Toxicities (DLTs)', 'timeFrame': 'From first dose up to end of cycle 1 (30 days)', 'description': 'To determine the maximum tolerated dose, safety was assessed by DLTs, defined as any grade ≥ 3 non-hematologic or extramedullary toxicity that occurred within 30 days starting with the first dose taken on day -2, and included the first treatment cycle in the dose escalation phase and in the first treatment cycle (28 days) in the dose expansion phase, that was considered to be possibly or probably related to study drug. Exceptions to this were the following: (1) Alopecia, anorexia or fatigue, (2) Grade 3 nausea and/or vomiting if not required tube feeding or total parenteral nutrition, or diarrhea if not required or prolonged hospitalization that was managed to grade ≤ 2 with standard antiemetic or antidiarrheal medications used at prescribed dose within 7 days of onset, (3) Grade 3 fever with neutropenia, with or without infection, (4) Grade 3 infection.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug up to 30 days after last dose of study drug (for participants who underwent hematopoietic stem cell transplantation \\[HSCT\\]: defined as AEs observed after starting study drug until the last dose before on study HSCT plus 30 days, and AEs that began after resumption of gilteritinib and within 30 days after the last dose of gilteritinib). AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (1-Mild, 2-Moderate, 3-Severe, 4-LifeThreatening, 5-Death).'}, {'measure': 'Area Under the Concentration-time Curve Over the 24-Hour Dosing Interval (AUC24) After Single and Multiple Doses of Gilteritinib', 'timeFrame': 'Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Maximum Concentration (Cmax) After Single and Multiple Doses of Gilteritinib', 'timeFrame': 'Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) After Single and Multiple Doses of Gilteritinib', 'timeFrame': 'Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Time to Observed Cmax (Tmax) After Single and Multiple Doses of Gilteritinib', 'timeFrame': 'Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Terminal Elimination Half-life (t1/2) After Multiple Doses of Gilteritinib', 'timeFrame': 'Cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Accumulation Ratio After Multiple Doses of Gilteritinib', 'timeFrame': 'Cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Complete Remission (CR) During the First 2 Cycles', 'timeFrame': 'During the first 2 cycles (56 days)', 'description': 'CR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CR when they had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an absolute neutrophil count (ANC) \\> 1 x 10\\^9/L, platelet count ≥ 100 x 10\\^9/L, normal marrow differential with \\< 5% blasts, had been red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion), had no presence of Auer rods and no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Exact 95% confidence interval was estimated using binomial distribution.'}, {'measure': 'Percentage of Participants With CR During Treatment', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'CR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CR when they had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an absolute neutrophil count (ANC) \\> 1 x 10\\^9/L, platelet count ≥ 100 x 10\\^9/L, normal marrow differential with \\< 5% blasts, had been red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion), had no presence of Auer rods and no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Exact 95% confidence interval was estimated using binomial distribution.'}, {'measure': 'Percentage of Participants With CR With Incomplete Platelet Recovery (CRp)', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'CRp was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRp when they achieved CR except for incomplete platelet recovery (\\< 100 x 10\\^9/L). Exact 95% confidence interval was estimated using the binomial distribution.'}, {'measure': 'Percentage of Participants With CR With Incomplete Hematological Recovery (CRi)', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'CRi was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRi when they fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia \\< 1 x 10\\^9/L with or without complete platelet recovery. RBC and platelet transfusion independence were not required. Exact 95% confidence interval was estimated using the binomial distribution.'}, {'measure': 'Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh)', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'CRh was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRh when they could not be classified as being in CR and had bone marrow blasts \\< 5% and partial hematologic recovery ANC \\>= 0.5 x 10\\^9/L and platelets \\>= 50 x 10\\^9/L. There should not be evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution. CRh was calculated only for participants who were FLT3 mutation positive.'}, {'measure': 'Percentage of Participants With Composite CR (CRc)', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'CRc was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRc when they had achieved either CR, complete remission with incomplete platelet recovery (CRp, defined as had achieved CR except for incomplete platelet recovery (\\< 100 x 10\\^9/L) or complete remission with incomplete hematologic recovery (CRi, defined as had fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia \\< 1 x 10\\^9/L with or without complete platelet recovery; RBC platelet transfusion independence not required). Exact 95% confidence interval was estimated using the binomial distribution.'}, {'measure': 'Percentage of Participants With Partial Remission (PR)', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'PR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in PR when they had bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and with a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate with the total marrow blasts between 5% and 25%. A value of less or equal than 5% blasts was also considered a PR if Auer rods were present. There should be no evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution.'}, {'measure': 'Percentage of Participants With Best Response', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'Best response was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). BR was defined as the best measured response for all visits (in the order of CR, CRp, CRi, and PR) post-treatment. Participants who achieved the best response of CR, CRp, CRi or PR were classified as responders. Participants who did not achieve at least PR were considered as non-responders. Exact 95% confidence interval was estimated using the binomial distribution.'}, {'measure': 'Percentage of Participants With Complete Remission and Complete Remission With Partial Hematologic Recovery (CR/CRh)', 'timeFrame': 'Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'Participants with CR/CRh were defined as participants who achieved either CR or CRh. Participants with CR had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an ANC \\> 1 x 10\\^9/L, platelet count ≥ 100 x 10\\^9/L, and normal marrow differential with \\< 5% blasts, had been RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). Also, there had been no presence of Auer rods, no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Participants with CRh could not be classified as being in CR and had bone marrow blasts \\< 5%, partial hematologic recovery ANC \\>= 0.5 x 10\\^9/L and platelets \\>= 50 x 10\\^9/L. There should not be evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution. CR/CRh was calculated only for participants who were FLT3 mutation positive.'}, {'measure': 'Duration of CR (DCR)', 'timeFrame': 'From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'DCR was defined as the time from the date of first CR until the date of documented relapse for participants who achieved CR. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study were considered non-events and censored at the last relapse-free disease assessment date. DCR was calculated using Kaplan-Meier method and therefore data are estimated.'}, {'measure': 'Duration of CRp (DCRp)', 'timeFrame': 'From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'DCRp was defined as the time from the date of first CRp until the date of documented relapse for participants who achieved CRp. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study were considered non-events and censored at the last relapse-free disease assessment date. DCRp was calculated using Kaplan-Meier method and therefore data are estimated.'}, {'measure': 'Duration of CRi (DCRi)', 'timeFrame': 'From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'DCRi was defined as the time from the date of first CRi until the date of documented relapse for participants who achieved CRi. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRi was calculated using Kaplan-Meier method and therefore data are estimated.'}, {'measure': 'Duration of CRh (DCRh)', 'timeFrame': 'From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'DCRh was defined as the time from the date of first CRh until the date of documented relapse for participants who achieved CRh but did not have a best response of CR. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRh was calculated using Kaplan-Meier method and therefore data are estimated. DCRh was calculated only for participants who were FLT3 mutation positive.'}, {'measure': 'Duration of CRc (DCRc)', 'timeFrame': 'From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'DCRc was defined as the time from the date of first CRc until the date of documented relapse for participants who achieved CRc. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRc was calculated using Kaplan-Meier method and therefore data are estimated.'}, {'measure': 'Duration of CR/CRh (DCRCRh)', 'timeFrame': 'From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'DCRCRh was defined as the time from the date of first DCRCRh until the date of documented relapse for participants who achieved CR or CRh. For participants who achieved both CR and CRh, the first CR date or CRh date, whichever occurred first, was used. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRCRh was calculated using Kaplan-Meier method and therefore data are estimated. DCRCRh was calculated only for participants who were FLT3 mutation positive.'}, {'measure': 'Duration of Response', 'timeFrame': 'From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'Duration of response was defined as the time from the date of either first CRc or PR until the date of documented relapse of any type for participants who achieved CRc or PR. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study are considered non-events and censored at the last relapse-free assessment date. Duration of response was calculated using Kaplan-Meier method and therefore data are estimated.'}, {'measure': 'Time to CR (TTCR)', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTCR was defined as the time from the first dose of study drug until the date of first CR.'}, {'measure': 'Time to CRp (TTCRp)', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTCRp was defined as the time from the first dose of study drug until the date of first CRp. TTCRp was evaluated for participants who achieved CRp.'}, {'measure': 'Time to CRi (TTCRi)', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTCRi was defined as the time from the first dose of study drug until the date of first CRi. TTCRi was evaluated for participants who achieved CRi.'}, {'measure': 'Time to First CR/CRh (TTFCRCRh)', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTFCRCRh was defined as the time from the first dose of study drug until the date of first either CR or CRh. TTFCRCRh was evaluated for participants who achieved CR or CRh. For participants who achieve both CR and CRh, the first CR date or CRh date, whichever occurs first was used. TTFCRCRh was calculated only for participants who were FLT3 mutation positive.'}, {'measure': 'Time to Best CR/CRh (TTBCRCRh)', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTBCRCRh was defined as the time from the first dose of study drug until the first date that the best response of CR or CRh was achieved. TTBCRCRh was evaluated for participants who achieved CR or CRh. For participants who achieve both CR and CRh, the first CR date was used. TTBCRCRh was calculated only for participants who were FLT3 mutation positive.'}, {'measure': 'Time to CRc (TTCRc)', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTCRc was defined as the time from the first dose of study drug until the date of first CRc. TTCRc was evaluated for participants who achieved CRc.'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTR was defined as the time from the first dose of study drug until the date of either first CRc or PR. TTR was evaluated for participants who achieved CRc or PR.'}, {'measure': 'Time to Best Response (TTBR)', 'timeFrame': 'From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)', 'description': 'TTBR was defined as the time from the first dose of study drug until the first disease assessment date when participant achieved best response. TTBR was evaluated in participants who achieved best response of CR, CRp, CRi, or PR.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)', 'description': 'The time from the date of first dose of study drug until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact. OS was calculated using Kaplan-Meier method and therefore data are estimated.'}, {'measure': 'Event Free Survival (EFS)', 'timeFrame': 'From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)', 'description': 'EFS was defined as the time from the date of first dose of study drug until the date of documented relapse, treatment failure or death from any cause, whichever occurred first. For a participant with none of these events, EFS was censored at the date of last relapse-free disease assessment. A participant without post-treatment disease assessment was censored at randomization date. Treatment failure included those participants who discontinued the treatment due to "progressive disease" or "lack of efficacy" without a previous response of CR, CRp, CRi or PR. Treatment failure date referred to the start of new anti-leukemia therapy or the last treatment evaluation date when new anti-leukemia therapy date was not available. For participants who were censored, last relapse-free disease assessment date referred to the participant\'s last disease assessment date. EFS was calculated using Kaplan-Meier method and therefore data are estimated.'}, {'measure': 'Leukemia Free Survival (LFS)', 'timeFrame': 'From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)', 'description': 'LFS was defined as the time from the date of first CRc until the date of documented relapse or death for participants who achieved CRc. For a participant who was not known to have relapsed or died, LFS was censored on the date of last relapse-free disease assessment date. LFS was calculated using Kaplan-Meier method and therefore data are estimated.'}, {'measure': 'Percentage of Participants Who Achieved Transfusion Conversion', 'timeFrame': 'Baseline (28 days prior to first dose until 28 days after the first dose) and postbaseline (from 29 days after first dose date until last dose date); median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days', 'description': 'Participants who achieved transfusion conversion were defined as the number of participants who were transfusion dependent at baseline period but became transfusion independent at post-baseline period divided by the total number of participants who were transfusion dependent at baseline period. Participants were considered baseline transfusion dependent if there were RBC or platelet transfusions within the baseline period. Participants were considered post-baseline transfusion independent if they were on treatment \\>=84 days, and if there was one consecutive 56 days without any RBC or platelet transfusion within post-baseline period. If participants were on treatment \\>28 days but \\<84 days, and there was no RBC or platelet transfusion within post-baseline period, or on treatment \\<=28 days, post-baseline transfusion status was not evaluable. Exact 95% confidence interval was estimated using the binomial distribution.'}, {'measure': 'Percentage of Participants Who Achieved Transfusion Maintenance', 'timeFrame': 'Baseline (28 days prior to first dose until 28 days after the first dose) and postbaseline (from 29 days after first dose date until last dose date); median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days', 'description': 'Participants who achieved transfusion maintenance were defined as the number of participants who were transfusion independent at baseline period and still maintained transfusion independent at post-baseline period divided by the total number of participants who were transfusion independent at baseline period.'}, {'measure': 'AUC24 of Gilteritinib in Co-administration With Voriconazole', 'timeFrame': 'Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Cmax of Gilteritinib in Co-administration With Voriconazole', 'timeFrame': 'Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'AUClast of Gilteritinib in Co-administration With Voriconazole', 'timeFrame': 'Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Tmax of Gilteritinib in Co-administration With Voriconazole', 'timeFrame': 'Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'AUC24 of Midazolam Administered With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'AUC24 of Metabolite 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Cmax of Midazolam Administered With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Cmax of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'AUClast of Midazolam Administered With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'AUClast of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Tmax of Midazolam Administered With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Tmax of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Area Under the Concentration-time Curve From the Time of Dosing Extrapolated to Time Infinity (AUCinf) of Cephalexin Administered With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Cmax of Cephalexin Administered With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'AUClast of Cephalexin Administered With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Tmax of Cephalexin Administered With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'T1/2 of Cephalexin Administered With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Apparent Total Systemic Clearance After Single or Multiple Extravascular Dosing (CL/F) of Cephalexin Administered With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Apparent Volume of Distribution During the Terminal Elimination Phase After Single Extravascular Dosing (Vz/F) of Cephalexin Administered With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)', 'description': 'Plasma samples were used for pharmacokinetic assessments.'}, {'measure': 'Amount of Drug Excreted in Urine (Aelast) of Cephalexin Administered With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)', 'description': 'Urine samples were used for pharmacokinetic assessments.'}, {'measure': 'Fraction of Drug Excreted Into Urine in Percentage (%Ae) of Cephalexin Administered With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)', 'description': 'Urine samples were used for pharmacokinetic assessments.'}, {'measure': 'Renal Clearance (CLr) of Cephalexin in Administered With and Without Gilteritinib', 'timeFrame': 'Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)', 'description': 'Urine samples were used for pharmacokinetic assessments.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Myeloid Leukemia', 'Gilteritinib', 'ASP2215'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '32304015', 'type': 'DERIVED', 'citation': 'James AJ, Smith CC, Litzow M, Perl AE, Altman JK, Shepard D, Kadokura T, Souda K, Patton M, Lu Z, Liu C, Moy S, Levis MJ, Bahceci E. Pharmacokinetic Profile of Gilteritinib: A Novel FLT-3 Tyrosine Kinase Inhibitor. Clin Pharmacokinet. 2020 Oct;59(10):1273-1290. doi: 10.1007/s40262-020-00888-w.'}, {'pmid': '28645776', 'type': 'DERIVED', 'citation': 'Perl AE, Altman JK, Cortes J, Smith C, Litzow M, Baer MR, Claxton D, Erba HP, Gill S, Goldberg S, Jurcic JG, Larson RA, Liu C, Ritchie E, Schiller G, Spira AI, Strickland SA, Tibes R, Ustun C, Wang ES, Stuart R, Rollig C, Neubauer A, Martinelli G, Bahceci E, Levis M. Selective inhibition of FLT3 by gilteritinib in relapsed or refractory acute myeloid leukaemia: a multicentre, first-in-human, open-label, phase 1-2 study. Lancet Oncol. 2017 Aug;18(8):1061-1075. doi: 10.1016/S1470-2045(17)30416-3. Epub 2017 Jun 20.'}, {'pmid': '26904404', 'type': 'DERIVED', 'citation': 'Kasi PM, Litzow MR, Patnaik MM, Hashmi SK, Gangat N. Clonal evolution of AML on novel FMS-like tyrosine kinase-3 (FLT3) inhibitor therapy with evolving actionable targets. Leuk Res Rep. 2016 Jan 12;5:7-10. doi: 10.1016/j.lrr.2016.01.002. eCollection 2016.'}], 'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/study.aspx?ID=303', 'label': 'Link to results on the Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to assess the safety and tolerability, including the maximum tolerated dose, of gilteritinib in participants with relapsed or treatment-refractory acute myeloid leukemia (AML). This study also determined the pharmacokinetic (PK) parameters of gilteritinib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is defined as morphologically documented primary or secondary AML by the World Health Organization (WHO) criteria (2008) and fulfills one of the following:\n\n * Refractory to at least 1 cycle of induction chemotherapy\n * Relapsed after achieving remission with a prior therapy\n* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Subject's interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), or at least 5 half-lives for prior experimental agents or noncytotoxic agents.\n* Subject must meet the following criteria as indicated on the clinical laboratory tests\\*:\n\n * Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\<2.5 x institutional upper limit normal (ULN)\n * Total serum bilirubin \\< 1.5x institutional ULN\n * Serum creatinine \\< 1.5 x institutional ULN or an estimated glomerular filtration rate (eGFR) of \\> 50 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation.\n* Subject agrees not to participate in another interventional study while on treatment.\n\nExclusion Criteria:\n\n* Subject was diagnosed as acute promyelocytic leukemia (APL).\n* Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).\n* Subject has active malignant tumors other than AML or Myelodysplastic syndrome (MDS).\n* Subject has persistent nonhematological toxicities of \\>= Grade 2 (Common Terminology Criteria for Adverse Events v4), with symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery).\n* Subject has had hematopoietic stem cell transplant (HSCT) and meets any of the following:\n\n * Is within 2 months of transplant from C1D1\n * Has clinically significant graft-versus-host disease requiring treatment\n * Has \\>= Grade 2 persistent non-hematological toxicity related to the transplant. Donor lymphocytes infusion (DLI) is not permitted \\<= 30 days prior to study registration or during the first cycle of treatment on the study in Cohort 1 and first two cycles of the treatment in Cohort 2\n* Subject has clinically active central nervous system leukemia\n* Subject has disseminated intravascular coagulation abnormality (DIC)\n* Subject has had major surgery within 4 weeks prior to the first study dose.\n* Subject has had radiation therapy within 4 weeks prior to the first study dose\n* Subject has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ≥ 45%\n* Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of Cytochrome P450-isozyme3A4 (CYP3A4) with the exception of antibiotics, antifungals, and antivirals that are used as standard of care post-transplant or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject\n* Subject required treatment with concomitant drugs that target serotonin 5HT1R or 5HT2BR receptors or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.\n* Subject has an active uncontrolled infection\n* Subject is known to have human immunodeficiency virus infection\n* Subject has active hepatitis B or C, or other active hepatic disorder"}, 'identificationModule': {'nctId': 'NCT02014558', 'briefTitle': 'Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 1/2 Open-Label, Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': '2215-CL-0101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 20 mg in Escalation Phase', 'description': 'Participants received a single dose of 20 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 20 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.', 'interventionNames': ['Drug: Gilteritinib', 'Drug: Voriconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 40 mg in Escalation Phase', 'description': 'Participants received a single dose of 40 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 40 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.', 'interventionNames': ['Drug: Gilteritinib']}, {'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 80 mg in Escalation Phase', 'description': 'Participants received a single dose of 80 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 80 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.', 'interventionNames': ['Drug: Gilteritinib']}, {'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 120 mg in Escalation Phase', 'description': 'Participants received a single dose of 120 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 120 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.', 'interventionNames': ['Drug: Gilteritinib']}, {'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 200 mg in Escalation Phase', 'description': 'Participants received a single dose of 200 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 200 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.', 'interventionNames': ['Drug: Gilteritinib']}, {'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 300 mg in Escalation Phase', 'description': 'Participants received a single dose of 300 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 300 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.', 'interventionNames': ['Drug: Gilteritinib']}, {'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 450 mg in Escalation Phase', 'description': 'Participants received a single dose of 450 mg gilteritinib orally on day -2 to evaluate pharmacokinetics of gilteritinib. Then starting on day 1 of cycle 1, participants received 450 mg gilteritinib orally once daily in 28-day cycles until disease progression or participant discontinuation in the escalation phase of the study.', 'interventionNames': ['Drug: Gilteritinib']}, {'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 20 mg in Expansion Phase', 'description': 'Participants received 20 mg gilteritinib orally once daily stating on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. Starting on day 16 of cycle 1, participants also received 200 mg voriconazole orally every 12 hours through day 1 of cycle 2.', 'interventionNames': ['Drug: Gilteritinib']}, {'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 40 mg in Expansion Phase', 'description': 'Participants received 40 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.', 'interventionNames': ['Drug: Gilteritinib']}, {'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 80 mg in Expansion Phase', 'description': 'Participants received 80 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.', 'interventionNames': ['Drug: Gilteritinib']}, {'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 120 mg in Expansion Phase', 'description': 'Participants received 120 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study.', 'interventionNames': ['Drug: Gilteritinib']}, {'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 200 mg in Expansion Phase', 'description': 'Participants received 200 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, certain participants also received 500 mg cephalexin as a single oral dose.', 'interventionNames': ['Drug: Gilteritinib', 'Drug: Cephalexin']}, {'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 300 mg in Expansion Phase', 'description': 'Participants received 300 mg gilteritinib orally once daily starting on day 1 of cycle 1 and continued in 28-day cycles until disease progression or participant discontinuation in the expansion phase of the study. On day -1 and day 15 of cycle 1, participants also received 2 mg midazolam as a single oral dose.', 'interventionNames': ['Drug: Gilteritinib', 'Drug: Midazolam']}], 'interventions': [{'name': 'Gilteritinib', 'type': 'DRUG', 'otherNames': ['ASP2215'], 'description': 'Participants received gilteritinib oral tablets (10 mg, 40 mg or 100 mg, depending on the dose) once daily without food allowed for at least 2 hours before and 1 hour after dosing starting from day -2 and day of cycle 1, for continuous 28-day cycles.', 'armGroupLabels': ['Gilteritinib 120 mg in Escalation Phase', 'Gilteritinib 120 mg in Expansion Phase', 'Gilteritinib 20 mg in Escalation Phase', 'Gilteritinib 20 mg in Expansion Phase', 'Gilteritinib 200 mg in Escalation Phase', 'Gilteritinib 200 mg in Expansion Phase', 'Gilteritinib 300 mg in Escalation Phase', 'Gilteritinib 300 mg in Expansion Phase', 'Gilteritinib 40 mg in Escalation Phase', 'Gilteritinib 40 mg in Expansion Phase', 'Gilteritinib 450 mg in Escalation Phase', 'Gilteritinib 80 mg in Escalation Phase', 'Gilteritinib 80 mg in Expansion Phase']}, {'name': 'Voriconazole', 'type': 'DRUG', 'description': 'Participants received 200 mg voriconazole tablets daily every 12 hours starting from day 16 of cycle 1 through day 1 of cycle 2.', 'armGroupLabels': ['Gilteritinib 20 mg in Escalation Phase']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Participants received a single oral dose of 2 mg of midazolam syrup on day -1 and day 15 of cycle 1.', 'armGroupLabels': ['Gilteritinib 300 mg in Expansion Phase']}, {'name': 'Cephalexin', 'type': 'DRUG', 'description': 'Participants received a single oral dose of 500 mg cephalexin tablet or capsule on day -1 and day 15 of cycle 1.', 'armGroupLabels': ['Gilteritinib 200 mg in Expansion Phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Site US10021', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site US10023', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'Site US10022', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90095-1678', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Site US10008', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Site US10005', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site US10001', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site US10015', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Site US10012', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Site US10003', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Site US10006', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Site US10011', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Site US10020', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Site US10010', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Site US10009', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Site US10013', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Site US10019', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Site US10014', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Site US10018', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Site US10004', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425-8900', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Site US10017', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Site US10007', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Site US10002', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Site US10026', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Site DE49002', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Site DE49004', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Site IT39001', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Executive Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicaltrials.astellas.com/transparency/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.', 'ipdSharing': 'YES', 'description': "Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.", 'accessCriteria': 'Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Global Development, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}