Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-20 @ 11:33 PM
Study NCT ID:
NCT00989261
Status:
COMPLETED
Last Update Posted:
2019-12-11
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C544967', 'term': 'quizartinib'}, {'id': 'D011208', 'term': 'Powders'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CTRinfo@dsi.com', 'phone': '1-908-992-6400', 'title': 'Daiichi Sankyo', 'organization': 'Contact for Clinical Trial Information'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event (AE) data was collected after the first dose of study drug through 30 days after the last dose of study drug, approximately 5 years.', 'description': 'Of note, AML disease progression (which includes the verbatim terms of progressive disease, disease progression, and relapsed AML) is reported as an AE in the data output and in the in-text tables; however, it is not considered an AE because of the population under study and is not further discussed.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'FLT3-ITD positive and negative populations will be divided into 2 cohorts as follows:\n\nParticipants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\nExploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.', 'otherNumAtRisk': 157, 'deathsNumAtRisk': 157, 'otherNumAffected': 151, 'seriousNumAtRisk': 157, 'deathsNumAffected': 71, 'seriousNumAffected': 134}, {'id': 'EG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\nExploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.', 'otherNumAtRisk': 176, 'deathsNumAtRisk': 176, 'otherNumAffected': 175, 'seriousNumAtRisk': 176, 'deathsNumAffected': 60, 'seriousNumAffected': 135}], 'otherEvents': [{'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 62, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 49, 'numAffected': 49}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 46, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 45, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 49, 'numAffected': 49}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Alanine aminotransferse increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 48, 'numAffected': 48}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 44, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 48, 'numAffected': 48}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 37, 'numAffected': 37}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 44, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 34, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 65, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 67, 'numAffected': 67}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mouth hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 85, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 89, 'numAffected': 89}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 57, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 70, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hair color changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 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157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Parainfluenzae virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pericoronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pseudomonal bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pseudomonal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory tract infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sepsis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Serratia bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinusitis fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Staphylococcal bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vulval abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vulval cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vulvitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Derived Disease Assessment Based on Local Morphology Including All On-Treatment Data (Safety Population, FLT3-ITD [+] Participants)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1\n* Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'OG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0\n\nTotal (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}], 'classes': [{'title': 'Composite complete remission (CRc)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission (CR)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission with incomplete platelet (CRp)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission with incomplete hematologic CRi', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Partial remission (PR)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'No response (NR)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within the first 3 cycles of treatment (84 days)', 'description': 'Derived disease assessment based on local morphology of bone marrow disease performed by each local site pathologist, including all on-treatment data (Safety Population, FLT3-ITD\\[+\\] Participants)\n\nModified from Cheson et al, abbreviations include the following: CR=complete remission; CRc=composite complete remission (CR+CRp+CRi); CRi=complete remission with incomplete hematological recovery, includes participants who met CRia criteria plus participants who met CRib criteria; CRia=all criteria specified for CR are met except for incomplete hematological recovery with residual neutropenia \\<1 x 10\\^9/L with or without complete platelet recovery. Red blood cell and platelet transfusion independence is not required; CRib=All criteria for CR or CRp are met, except for recent red blood cell or platelet transfusion; CRp=complete remission with incomplete platelet recovery; NR=no response; PR=partial remission.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Derived disease assessments were conducted in the Safety Population (FLT3-ITD \\[+\\] participants).'}, {'type': 'PRIMARY', 'title': 'Derived Disease Assessment Based on Local Morphology Including All On-Treatment Data (Safety Population, FLT3-ITD [-] Participants)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1\n* Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'OG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0\n\nTotal (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}], 'classes': [{'title': 'Composite complete remission (CRc)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission (CR)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission with incomplete platelet (CRp)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Complete remission with incomplete hematologic CRi', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Partial remission (PR)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'No response (NR)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within the first 3 cycles of treatment (84 days)', 'description': 'Derived disease assessment based on local morphology of bone marrow disease performed by each local site pathologist, including all on-treatment data (Safety Population, FLT3-ITD\\[-\\] Participants)\n\nModified from Cheson et al, abbreviations include the following: CR=complete remission; CRc=composite complete remission (CR+CRp+CRi); CRi=complete remission with incomplete hematological recovery, includes participants who met CRia criteria plus participants who met CRib criteria; CRia=all criteria specified for CR are met except for incomplete hematological recovery with residual neutropenia \\<1 x 10\\^9/L with or without complete platelet recovery. Red blood cell and platelet transfusion independence is not required; CRib=All criteria for CR or CRp are met, except for recent red blood cell or platelet transfusion; CRp=complete remission with incomplete platelet recovery; NR=no response; PR=partial remission.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Derived disease assessments were conducted in the Safety Population (FLT3-ITD \\[-\\] participants).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Composite Complete Remission (CRc), Categorised by FLT3-ITD Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1\n* Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'OG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0\n\nTotal (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}], 'classes': [{'title': 'FLT3-ITD(+)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'FLT3-ITD(-)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 28 months', 'description': 'CRc is defined as composite complete remission (CR+CRp+CRi) - CR = complete remission; CRp = complete remission with incomplete platelet recovery; CRi = complete remission with incomplete hematological recovery, includes participants who met CRia criteria plus participants who met CRib criteria; CRia = all criteria specified for CR are met except for incomplete hematological recovery with residual neutropenia \\<1 x 10\\^9/L with or without complete platelet recovery. Red blood cell and platelet transfusion independence is not required; CRib = all criteria for CR or CRp are met, except for recent red blood cell or platelet transfusion.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Composite complete remission was assessed in the Safety Population.'}, {'type': 'SECONDARY', 'title': 'Duration of Composite Complete Remission in FLT3-ITD (+) Participants Who Achieved CRc Based on All On-Treatment Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1\n* Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'OG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0\n\nTotal (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '15.7'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '16.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time at which CRc was achieved until disease progression or death, up to approximately 3 years post treatment', 'description': 'Kaplan-Meier analysis of duration of composite complete remission derived based on local morphology including all on-treatment data (Safety Population).\n\nThe definition of relapse at CRc includes an evaluation of blasts in the peripheral blood of \\>1%.Though not specified in the protocol, the addition of these criteria was deemed necessary for consistency with the Cheson criteria.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of composite complete remission was assessed in the Safety Population based on FLT3-ITD (+) participants available for this analysis (Cohort 1: n=63; Cohort 2: n=62).'}, {'type': 'SECONDARY', 'title': 'Duration of Composite Complete Remission in FLT3-ITD (-) Participants Who Achieved CRc Based on All On-Treatment Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1\n* Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'OG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0\n\nTotal (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '30.4'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '8.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time at which CRc was achieved until disease progression or death, up to approximately 3 years post treatment', 'description': 'Kaplan-Meier analysis of duration of composite complete remission derived based on local morphology including all on-treatment data (Safety Population).\n\nThe definition of relapse at CRc includes an evaluation of blasts in the peripheral blood of \\>1%.Though not specified in the protocol, the addition of these criteria was deemed necessary for consistency with the Cheson criteria.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of composite complete remission was assessed in the Safety Population based on FLT3-ITD (-) participants available for this analysis (Cohort 1: n=16; Cohort 2: n=12).'}, {'type': 'SECONDARY', 'title': 'Duration of Any Response in FLT3-ITD (+) Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1\n* Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'OG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0\n\nTotal (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '21.3'}, {'value': '14.1', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '22.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of any response until disease progression or death, up to approximately 3 years post treatment', 'description': 'Kaplan-Meier analysis of duration of any response (CR, CRp, CRi, or PR), derived based on local morphology for participants who achieved a response during the first 3 cycles of treatment (Safety Population).', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response (based on local morphology) was assessed in the Safety Population (FLT3-ITD \\[+\\] participants).'}, {'type': 'SECONDARY', 'title': 'Duration of Any Response in FLT3-ITD (-) Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1\n* Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'OG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0\n\nTotal (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '34.1'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '8.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of any response until disease progression or death, up to approximately 3 years post treatment', 'description': 'Kaplan-Meier analysis of duration of any response (CR, CRp, CRi, or PR), derived based on local morphology for participants who achieved a response during the first 3 cycles of treatment (Safety Population).', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response (based on local morphology) was assessed in the Safety Population (FLT3-ITD \\[-\\] participants).'}, {'type': 'SECONDARY', 'title': 'Median Duration of Leukemia-free Survival in FLT3-ITD (+) Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1\n* Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'OG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0\n\nTotal (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '14.3'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '19.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time CRc was achieved until disease progression or death, up to approximately 3 years post treatment', 'description': 'Kaplan-Meier analysis of leukemia-free survival in participants who achieved a CRc in the first three cycles of treatment derived based on local morphology (Safety Population).', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Leukemia-free survival (based on local morphology) was assessed in the Safety Population (FLT3-ITD \\[+\\] participants).'}, {'type': 'SECONDARY', 'title': 'Median Duration of Leukemia-free Survival in FLT3-ITD (-) Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1\n* Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'OG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0\n\nTotal (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '26.1'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '8.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time CRc was achieved until disease progression or death, up to approximately 3 years post treatment', 'description': 'Kaplan-Meier analysis of leukemia-free survival in participants who achieved a CRc in the first three cycles of treatment derived based on local morphology (Safety Population).', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Leukemia-free survival (based on local morphology) was assessed in the Safety Population (FLT3-ITD \\[-\\] participants).'}, {'type': 'SECONDARY', 'title': 'Median Duration of Overall Survival in FLT3-ITD (+) Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1\n* Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'OG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0\n\nTotal (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.4', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '29.7'}, {'value': '24.0', 'groupId': 'OG001', 'lowerLimit': '21.1', 'upperLimit': '27.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from first dose to death from any cause, up to 3 years post treatment', 'description': 'Kaplan-Meier analysis of overall survival (Safety Population)', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall survival was assessed in the Safety Population (FLT3-ITD \\[+\\] participants).'}, {'type': 'SECONDARY', 'title': 'Median Duration of Overall Survival in FLT3-ITD (-) Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1\n* Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'OG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0\n\nTotal (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '29.4'}, {'value': '25.1', 'groupId': 'OG001', 'lowerLimit': '18.1', 'upperLimit': '37.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from first dose to death from any cause, up to approximately 3 years post treatment', 'description': 'Kaplan-Meier analysis of overall survival (Safety Population)', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall survival was assessed in the Safety Population (FLT3-ITD \\[-\\] participants).'}, {'type': 'SECONDARY', 'title': 'Early Treatment-related Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=24): FLT3-ITD(+): n=22; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=133): FLT3-ITD(+): n=90; FLT3-ITD(-): n=42; unknown: n=1\n* Total (N=157): FLT3-ITD (+): n=112; FLT3-ITD(-): n=44; unknown: n=1\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'OG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\n* Exploratory (N=38): FLT3-ITD(+): n=36; FLT3-ITD(-): n=2; unknown: n=0\n* Confirmatory (N=138): FLT3-ITD(+): n=100; FLT3-ITD(-): n=38; unknown: n=0\n\nTotal (N=176): FLT3-ITD(+): n=136; FLT3-ITD(-): n=40; unknown: n=0\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within first 3 cycles of treatment (84 days)', 'description': 'Early treatment-related deaths included all treatment-related deaths prior to the end of Cycle 3 with a 3-day window (Cycle 3 end date + 3 days), unless the death was following a CRc response assessed by the Investigator.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Early treatment-related deaths were assessed in the Safety Population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\nExploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'FG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\nExploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Still in follow up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 333 participants from 9 countries (United States, Germany, France, Italy, United Kingdom, Spain, Netherlands, Canada, and Poland) who met all inclusion and none of the exclusion criteria were included in the study.', 'preAssignmentDetails': 'All participants in both cohorts initially received a starting dose of 200 mg/day quizartinib (maximum tolerated dose). To ensure complete inhibition of FLT3, all male subjects in both cohorts later received a starting dose of 135 mg/day quizartinib, and all females received a starting dose of 90 mg/day.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1; ≥60 Years of Age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\nExploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'BG001', 'title': 'Cohort 2; ≥18 Years of Age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\nExploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '86'}, {'value': '51.0', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '77'}, {'value': '63.0', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Less than 60 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}, {'title': 'At least 60 years', 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '74.66', 'spread': '14.75', 'groupId': 'BG000'}, {'value': '74.76', 'spread': '19.41', 'groupId': 'BG001'}, {'value': '74.72', 'spread': '17.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 333}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'dispFirstSubmitDate': '2016-09-30', 'completionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-03', 'studyFirstSubmitDate': '2009-10-01', 'dispFirstSubmitQcDate': '2016-09-30', 'resultsFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2009-10-01', 'dispFirstPostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-11', 'studyFirstPostDateStruct': {'date': '2009-10-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Derived Disease Assessment Based on Local Morphology Including All On-Treatment Data (Safety Population, FLT3-ITD [+] Participants)', 'timeFrame': 'Within the first 3 cycles of treatment (84 days)', 'description': 'Derived disease assessment based on local morphology of bone marrow disease performed by each local site pathologist, including all on-treatment data (Safety Population, FLT3-ITD\\[+\\] Participants)\n\nModified from Cheson et al, abbreviations include the following: CR=complete remission; CRc=composite complete remission (CR+CRp+CRi); CRi=complete remission with incomplete hematological recovery, includes participants who met CRia criteria plus participants who met CRib criteria; CRia=all criteria specified for CR are met except for incomplete hematological recovery with residual neutropenia \\<1 x 10\\^9/L with or without complete platelet recovery. Red blood cell and platelet transfusion independence is not required; CRib=All criteria for CR or CRp are met, except for recent red blood cell or platelet transfusion; CRp=complete remission with incomplete platelet recovery; NR=no response; PR=partial remission.'}, {'measure': 'Derived Disease Assessment Based on Local Morphology Including All On-Treatment Data (Safety Population, FLT3-ITD [-] Participants)', 'timeFrame': 'Within the first 3 cycles of treatment (84 days)', 'description': 'Derived disease assessment based on local morphology of bone marrow disease performed by each local site pathologist, including all on-treatment data (Safety Population, FLT3-ITD\\[-\\] Participants)\n\nModified from Cheson et al, abbreviations include the following: CR=complete remission; CRc=composite complete remission (CR+CRp+CRi); CRi=complete remission with incomplete hematological recovery, includes participants who met CRia criteria plus participants who met CRib criteria; CRia=all criteria specified for CR are met except for incomplete hematological recovery with residual neutropenia \\<1 x 10\\^9/L with or without complete platelet recovery. Red blood cell and platelet transfusion independence is not required; CRib=All criteria for CR or CRp are met, except for recent red blood cell or platelet transfusion; CRp=complete remission with incomplete platelet recovery; NR=no response; PR=partial remission.'}, {'measure': 'Number of Participants With Composite Complete Remission (CRc), Categorised by FLT3-ITD Status', 'timeFrame': 'within 28 months', 'description': 'CRc is defined as composite complete remission (CR+CRp+CRi) - CR = complete remission; CRp = complete remission with incomplete platelet recovery; CRi = complete remission with incomplete hematological recovery, includes participants who met CRia criteria plus participants who met CRib criteria; CRia = all criteria specified for CR are met except for incomplete hematological recovery with residual neutropenia \\<1 x 10\\^9/L with or without complete platelet recovery. Red blood cell and platelet transfusion independence is not required; CRib = all criteria for CR or CRp are met, except for recent red blood cell or platelet transfusion.'}], 'secondaryOutcomes': [{'measure': 'Duration of Composite Complete Remission in FLT3-ITD (+) Participants Who Achieved CRc Based on All On-Treatment Data', 'timeFrame': 'From time at which CRc was achieved until disease progression or death, up to approximately 3 years post treatment', 'description': 'Kaplan-Meier analysis of duration of composite complete remission derived based on local morphology including all on-treatment data (Safety Population).\n\nThe definition of relapse at CRc includes an evaluation of blasts in the peripheral blood of \\>1%.Though not specified in the protocol, the addition of these criteria was deemed necessary for consistency with the Cheson criteria.'}, {'measure': 'Duration of Composite Complete Remission in FLT3-ITD (-) Participants Who Achieved CRc Based on All On-Treatment Data', 'timeFrame': 'From time at which CRc was achieved until disease progression or death, up to approximately 3 years post treatment', 'description': 'Kaplan-Meier analysis of duration of composite complete remission derived based on local morphology including all on-treatment data (Safety Population).\n\nThe definition of relapse at CRc includes an evaluation of blasts in the peripheral blood of \\>1%.Though not specified in the protocol, the addition of these criteria was deemed necessary for consistency with the Cheson criteria.'}, {'measure': 'Duration of Any Response in FLT3-ITD (+) Participants', 'timeFrame': 'From the time of any response until disease progression or death, up to approximately 3 years post treatment', 'description': 'Kaplan-Meier analysis of duration of any response (CR, CRp, CRi, or PR), derived based on local morphology for participants who achieved a response during the first 3 cycles of treatment (Safety Population).'}, {'measure': 'Duration of Any Response in FLT3-ITD (-) Participants', 'timeFrame': 'From the time of any response until disease progression or death, up to approximately 3 years post treatment', 'description': 'Kaplan-Meier analysis of duration of any response (CR, CRp, CRi, or PR), derived based on local morphology for participants who achieved a response during the first 3 cycles of treatment (Safety Population).'}, {'measure': 'Median Duration of Leukemia-free Survival in FLT3-ITD (+) Participants', 'timeFrame': 'From the time CRc was achieved until disease progression or death, up to approximately 3 years post treatment', 'description': 'Kaplan-Meier analysis of leukemia-free survival in participants who achieved a CRc in the first three cycles of treatment derived based on local morphology (Safety Population).'}, {'measure': 'Median Duration of Leukemia-free Survival in FLT3-ITD (-) Participants', 'timeFrame': 'From the time CRc was achieved until disease progression or death, up to approximately 3 years post treatment', 'description': 'Kaplan-Meier analysis of leukemia-free survival in participants who achieved a CRc in the first three cycles of treatment derived based on local morphology (Safety Population).'}, {'measure': 'Median Duration of Overall Survival in FLT3-ITD (+) Participants', 'timeFrame': 'Time from first dose to death from any cause, up to 3 years post treatment', 'description': 'Kaplan-Meier analysis of overall survival (Safety Population)'}, {'measure': 'Median Duration of Overall Survival in FLT3-ITD (-) Participants', 'timeFrame': 'Time from first dose to death from any cause, up to approximately 3 years post treatment', 'description': 'Kaplan-Meier analysis of overall survival (Safety Population)'}, {'measure': 'Early Treatment-related Death', 'timeFrame': 'Within first 3 cycles of treatment (84 days)', 'description': 'Early treatment-related deaths included all treatment-related deaths prior to the end of Cycle 3 with a 3-day window (Cycle 3 end date + 3 days), unless the death was following a CRc response assessed by the Investigator.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AML', 'AC220', 'acute', 'FLT3', 'inhibitor', 'kinase', 'leukemia', 'leukaemia', 'myeloid', 'relapsed', 'refractory'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '29859851', 'type': 'DERIVED', 'citation': 'Cortes J, Perl AE, Dohner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Kramer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.'}]}, 'descriptionModule': {'briefSummary': 'AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Current enrollment is open only to FLT3-ITD positive, Cohort 1.\n\nInclusion Criteria:\n\n1. Males and females age ≥18 years in second relapse or refractory.\n2. Males and females age ≥60 years in first relapse or refractory.\n3. Must have baseline bone marrow sample taken.\n4. Morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS with ≥20% bone marrow or peripheral blasts), as defined by the World Health Organization (WHO) criteria, confirmed by pathology review at treating institution.\n5. Able to swallow the liquid study drug.\n6. Eastern Cooperative Oncology Group performance status of 0 to 2\n7. In the absence of rapidly progressing disease, the interval from prior treatment to time of AC220 administration will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. The use of chemotherapeutic or antileukemic agents other than hydroxyurea is not permitted during the study with the possible exception of intrathecal (IT) therapy at the discretion of the Investigator and with the agreement of the Sponsor.\n8. Persistent chronic clinically significant non-hematological toxicities from prior treatment must be ≤Grade 1.\n9. Prior therapy with FLT3 inhibitors is permitted, except previous treatment with AC220.\n10. Serum creatinine ≤1.5 × upper limit of normal (ULN) and glomerular filtration rate (GFR) \\> 30 mL/min\n11. Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits.\n12. Total serum bilirubin ≤1.5 × ULN\n13. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5 × ULN\n14. Females of childbearing potential must have a negative pregnancy test (urine β-hCG).\n15. Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study.\n16. Written informed consent must be provided.\n\nExclusion Criteria:\n\n1. Patients over the age of 85 years except at the discretion of the Investigator and with agreement of the Sponsor.\n2. Diagnosis of acute promyelocytic leukemia\n3. Diagnosis of chronic myelogenous leukemia (CML) in blast crisis\n4. AML in relapse or refractory after 3 or more previous lines of chemotherapy (and/or HSCT) treatment\n5. AML or antecedent MDS secondary to prior chemotherapy\n6. Persistent clinically significant non-hematological toxicity that is Grade \\>1 by NCI CTCAE v4 from prior chemotherapy\n7. Patients who have had HSCT and are within 100 days of transplant and/or are still taking immunosuppressive drugs and/or have clinically significant graft-versus-host disease requiring treatment and/or have \\>Grade 1 persistent non hematological toxicity related to the transplant\n8. Clinically active central nervous system (CNS) leukemia. Patients with CNS leukemia, which is controlled, but who are still receiving IT therapy at study entry may be considered eligible and continue receive IT therapy at the discretion of the Investigator and with agreement of the Sponsor.\n9. Patients who have previously received AC220\n10. Disseminated intravascular coagulation (DIC) (diagnosis by laboratory or clinical assessment)\n11. Major surgery within 4 weeks prior to enrollment in the study\n12. Radiation therapy within 4 weeks prior to, or concurrent with study\n13. Use of concomitant drugs that prolong the time between the start of the Q wave and the end of the T wave (QT)/corrected interval between the Q wave and T wave (QTc) interval and/or are CYP3A4 inhibitors are prohibited with the exception of antibiotics, antifungals, and other antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient.\n14. Uncontrolled or significant cardiovascular disease\n15. Women who are pregnant, lactating, or unwilling to use contraception if of childbearing potential\n16. Men who are unwilling to use contraception if their partners are of childbearing potential\n17. Active, uncontrolled infection\n18. Human immunodeficiency virus positivity\n19. Active hepatitis B or C or other active liver disease\n20. History of cancer, except Stage 1 cervix or nonmelanotic skin cancer, with the possible exception of patients in complete remission'}, 'identificationModule': {'nctId': 'NCT00989261', 'acronym': 'ACE', 'briefTitle': 'Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'Phase 2 Open-Label, AC220 Monotherapy Efficacy (ACE) Study in Patients With Acute Myeloid Leukemia (AML) With and Without FLT3-ITD Activating Mutations', 'orgStudyIdInfo': {'id': 'AC220-002'}, 'secondaryIdInfos': [{'id': '2009-013093-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1; ≥60 years of age', 'description': 'Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \\<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.\n\nExploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.', 'interventionNames': ['Drug: Compound AC220']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2; ≥18 years of age', 'description': 'Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.\n\nExploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)\n\nAfter an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.', 'interventionNames': ['Drug: Compound AC220']}], 'interventions': [{'name': 'Compound AC220', 'type': 'DRUG', 'otherNames': ['AC010220 × 2HCl, oral powder for reconstitution'], 'description': 'Precomplexed powder in bottle formulation supplied as 200 mg in a 60 cc polyethylene terephthalate (PET) plastic bottle. Requires reconstitution by a pharmacist, must be stored securely, and protected from light.', 'armGroupLabels': ['Cohort 1; ≥60 years of age', 'Cohort 2; ≥18 years of age']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Milton S. 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