Viewing Study NCT00651261

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Ignite Creation Date: 2025-12-24 @ 12:59 PM
Ignite Modification Date: 2026-04-08 @ 1:47 PM
Study NCT ID: NCT00651261
Status: UNKNOWN
Last Update Posted: 2021-08-18
First Post: 2008-04-01
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015471', 'term': 'Leukemia, Basophilic, Acute'}, {'id': 'D015472', 'term': 'Leukemia, Eosinophilic, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D007947', 'term': 'Leukemia, Megakaryoblastic, Acute'}, {'id': 'D007948', 'term': 'Leukemia, Monocytic, Acute'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D015479', 'term': 'Leukemia, Myelomonocytic, Acute'}, {'id': 'D004915', 'term': 'Leukemia, Erythroblastic, Acute'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'C059539', 'term': 'midostaurin'}, {'id': 'C018038', 'term': 'dexamethasone acetate'}], 'ancestors': [{'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rstone@partners.org', 'title': 'Richard Stone, MD', 'organization': 'Dana Farber Cancer Institute'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': '709 participants were evaluated for adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Induction and Consolidation Chemotherapy Plus Midostaurin', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.', 'otherNumAtRisk': 355, 'otherNumAffected': 321, 'seriousNumAtRisk': 355, 'seriousNumAffected': 157}, {'id': 'EG001', 'title': 'Induction and Consolidation Chemotherapy Plus Placebo', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.', 'otherNumAtRisk': 354, 'otherNumAffected': 324, 'seriousNumAtRisk': 354, 'seriousNumAffected': 154}], 'otherEvents': [{'term': 'Blood disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 422, 'numAffected': 246}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 394, 'numAffected': 238}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1059, 'numAffected': 312}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 940, 'numAffected': 311}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Lymphatic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Cardiac pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Cardiac valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Conduction disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 13, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Premature ventricular contractions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 15, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 29, 'numAffected': 23}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ventricular bigeminy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'External ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'External ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Middle ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Endocrine disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dry eye syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Eyelid function disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Flashing vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Optic nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Vitreous hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Watering eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 15, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 78, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 84, 'numAffected': 67}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Anal exam abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Anal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Anal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Anal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Anal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 18, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Colonic hemorrhage', 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{'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 25, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Electrocardiogram QTc interval prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 81, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 48, 'numAffected': 36}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Fibrinogen decreased', 'stats': [{'groupId': 'EG000', 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{'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pulmonary hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Respiratory tract hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Retinoic acid syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Tracheal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Voice alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hand-and-foot syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 45, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 52, 'numAffected': 34}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Rash desquamating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 70, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 71, 'numAffected': 66}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 28, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 30, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Lymphangitic streak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Lymphedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction and Consolidation Chemotherapy Plus Midostaurin', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.'}, {'id': 'OG001', 'title': 'Induction and Consolidation Chemotherapy Plus Placebo', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.7', 'comment': 'The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment.', 'groupId': 'OG000', 'lowerLimit': '31.5', 'upperLimit': 'NA'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '18.6', 'upperLimit': '42.9'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.96', 'statisticalMethod': '1-sided stratified log-rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of study (Up to 10 years)', 'description': 'Overall survival (OS) was defined as the time interval from randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Event- Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction and Consolidation Chemotherapy Plus Midostaurin', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.'}, {'id': 'OG001', 'title': 'Induction and Consolidation Chemotherapy Plus Placebo', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '10.7'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '5.9'}]}]}], 'analyses': [{'pValue': '0.0024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.93', 'statisticalMethod': '1-sided stratified log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of study (Up to 10 years)', 'description': 'Event free survival (EFS) was defined as the time from randomization until the earliest qualifying event, including: failure to obtain a CR on or before 60 days of initiation of protocol therapy; relapse; or death from any cause. Patients alive and event free at the time of analysis were censored on the date of last clinical assessment. The median EFS with 95% CI was estimated using the Kaplan-Meier method.\n\nDue to a higher than expected transplant rate, EFS was promoted to be a key secondary endpoint.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction and Consolidation Chemotherapy Plus Midostaurin', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.'}, {'id': 'OG001', 'title': 'Induction and Consolidation Chemotherapy Plus Placebo', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median overall survival with censoring for transplant has not been reached', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median overall survival with censoring for transplant has not been reached', 'groupId': 'OG001', 'lowerLimit': '27.4', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of study (Up to 10 years)', 'description': 'Overall survival (OS) was defined as the time interval from randomization to death from any cause. Any participants who received a stem cell transplant were censored at the time of transplant. The median OS with 95% CI was estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complete Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction and Consolidation Chemotherapy Plus Midostaurin', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.'}, {'id': 'OG001', 'title': 'Induction and Consolidation Chemotherapy Plus Placebo', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '64'}, {'value': '54', 'groupId': 'OG001', 'lowerLimit': '48', 'upperLimit': '59'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Induction therapy (up to 60 days)', 'description': 'Percentage of participants who achieved a complete response (CR). A CR was defined as normalization of blood counts and a marrow showing less than 5% blasts occurring on or before day 60.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease-free Survival (DFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction and Consolidation Chemotherapy Plus Midostaurin', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.'}, {'id': 'OG001', 'title': 'Induction and Consolidation Chemotherapy Plus Placebo', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'comment': 'The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment.', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': 'NA'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '23.5'}]}]}], 'analyses': [{'pValue': '0.0049', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': '1-sided stratified log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of study (Up to 10 years)', 'description': 'Disease free survival (DFS) is defined as the time from documentation of first CR at any time to the first of relapse or death from any cause in participants who achieved a CR.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'DFS Rate One Year After Completing the Planned Continuation Phase', 'timeFrame': '30 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Induction and Consolidation Chemotherapy Plus Midostaurin', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.'}, {'id': 'FG001', 'title': 'Induction and Consolidation Chemotherapy Plus Placebo', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '360'}, {'groupId': 'FG001', 'numSubjects': '357'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '291'}, {'groupId': 'FG001', 'numSubjects': '306'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'Induction failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'Alternative therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'Other disease or participant decisions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Never treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Between May 2008 and October 2001, 3,277 participants were pre-registered. Of those, 900 participants had a documented FLT3 mutation. 717 participants were enrolled onto this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'BG000'}, {'value': '357', 'groupId': 'BG001'}, {'value': '717', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Induction and Consolidation Chemotherapy Plus Midostaurin', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.'}, {'id': 'BG001', 'title': 'Induction and Consolidation Chemotherapy Plus Placebo', 'description': 'Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.1', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '59.8'}, {'value': '48.6', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '60.9'}, {'value': '47.9', 'groupId': 'BG002', 'lowerLimit': '18.0', 'upperLimit': '60.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '248', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '491', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'FLT3 mutational subtype', 'classes': [{'title': 'TKD (No ITD)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}]}, {'title': 'ITD Allelic ratio <0.7', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}]}]}, {'title': 'ITD Allelic ratio >=0.7', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Mutations in the gene encoding the trans-membrane tyrosine kinase FLT3. FLT3 internal tandem duplications (ITD) mutation which results in a duplication between 3 and greater than 100 amino acids most commonly located in the juxtamembrane region. Tyrosine kinase domain (TKD) point mutations are the remainder of those with FLT3 mutations. FLT3 testing was done centrally.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 717}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'lastUpdateSubmitDate': '2021-08-16', 'studyFirstSubmitDate': '2008-04-01', 'resultsFirstSubmitDate': '2016-12-12', 'studyFirstSubmitQcDate': '2008-04-01', 'lastUpdatePostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-12', 'studyFirstPostDateStruct': {'date': '2008-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Duration of study (Up to 10 years)', 'description': 'Overall survival (OS) was defined as the time interval from randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Event- Free Survival', 'timeFrame': 'Duration of study (Up to 10 years)', 'description': 'Event free survival (EFS) was defined as the time from randomization until the earliest qualifying event, including: failure to obtain a CR on or before 60 days of initiation of protocol therapy; relapse; or death from any cause. Patients alive and event free at the time of analysis were censored on the date of last clinical assessment. The median EFS with 95% CI was estimated using the Kaplan-Meier method.\n\nDue to a higher than expected transplant rate, EFS was promoted to be a key secondary endpoint.'}, {'measure': 'Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant', 'timeFrame': 'Duration of study (Up to 10 years)', 'description': 'Overall survival (OS) was defined as the time interval from randomization to death from any cause. Any participants who received a stem cell transplant were censored at the time of transplant. The median OS with 95% CI was estimated using the Kaplan-Meier method.'}, {'measure': 'Complete Response Rate', 'timeFrame': 'Induction therapy (up to 60 days)', 'description': 'Percentage of participants who achieved a complete response (CR). A CR was defined as normalization of blood counts and a marrow showing less than 5% blasts occurring on or before day 60.'}, {'measure': 'Disease-free Survival (DFS)', 'timeFrame': 'Duration of study (Up to 10 years)', 'description': 'Disease free survival (DFS) is defined as the time from documentation of first CR at any time to the first of relapse or death from any cause in participants who achieved a CR.'}, {'measure': 'DFS Rate One Year After Completing the Planned Continuation Phase', 'timeFrame': '30 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adult acute basophilic leukemia', 'adult acute eosinophilic leukemia', 'adult acute lymphoblastic leukemia', 'adult acute megakaryoblastic leukemia (M7)', 'adult acute minimally differentiated myeloid leukemia (M0)', 'adult acute monoblastic leukemia (M5a)', 'adult acute monocytic leukemia (M5b)', 'adult acute myeloblastic leukemia with maturation (M2)', 'adult acute myeloblastic leukemia without maturation (M1)', 'adult acute myeloid leukemia with 11q23 (MLL) abnormalities', 'adult acute myeloid leukemia with inv(16)(p13;q22)', 'adult acute myeloid leukemia with t(16;16)(p13;q22)', 'adult acute myeloid leukemia with t(8;21)(q22;q22)', 'adult acute myelomonocytic leukemia (M4)', 'adult erythroleukemia (M6a)', 'adult pure erythroid leukemia (M6b)', 'untreated adult acute myeloid leukemia'], 'conditions': ['Leukemia']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Stone RM, Dohner H, Ehninger G, et al.: CALGB 10603 (RATIFY): A randomized phase III study of induction (daunorubicin/cytarabine) and consolidation (high-dose cytarabine) chemotherapy combined with midostaurin or placebo in treatment-naive patients with FLT3 mutated AML. [Abstract] J Clin Oncol 29 (Suppl 15): A-TPS199, 2011.'}, {'pmid': '36184192', 'type': 'DERIVED', 'citation': 'Seffernick AE, Mrozek K, Nicolet D, Stone RM, Eisfeld AK, Byrd JC, Archer KJ. High-dimensional genomic feature selection with the ordered stereotype logit model. Brief Bioinform. 2022 Nov 19;23(6):bbac414. doi: 10.1093/bib/bbac414.'}, {'pmid': '33049054', 'type': 'DERIVED', 'citation': 'Voso MT, Larson RA, Jones D, Marcucci G, Prior T, Krauter J, Heuser M, Lavorgna S, Nomdedeu J, Geyer SM, Walker A, Wei AH, Sierra J, Sanz MA, Brandwein JM, de Witte TM, Jansen JH, Niederwieser D, Appelbaum FR, Medeiros BC, Tallman MS, Schlenk RF, Ganser A, Amadori S, Cheng Y, Chen Y, Pallaud C, Du L, Piciocchi A, Ehninger G, Byrd J, Thiede C, Dohner K, Stone RM, Dohner H, Bloomfield CD, Lo-Coco F. Midostaurin in patients with acute myeloid leukemia and FLT3-TKD mutations: a subanalysis from the RATIFY trial. Blood Adv. 2020 Oct 13;4(19):4945-4954. doi: 10.1182/bloodadvances.2020002904.'}, {'pmid': '31375516', 'type': 'DERIVED', 'citation': 'Walker CJ, Kohlschmidt J, Eisfeld AK, Mrozek K, Liyanarachchi S, Song C, Nicolet D, Blachly JS, Bill M, Papaioannou D, Oakes CC, Giacopelli B, Genutis LK, Maharry SE, Orwick S, Archer KJ, Powell BL, Kolitz JE, Uy GL, Wang ES, Carroll AJ, Stone RM, Byrd JC, de la Chapelle A, Bloomfield CD. Genetic Characterization and Prognostic Relevance of Acquired Uniparental Disomies in Cytogenetically Normal Acute Myeloid Leukemia. Clin Cancer Res. 2019 Nov 1;25(21):6524-6531. doi: 10.1158/1078-0432.CCR-19-0725. Epub 2019 Aug 2.'}, {'pmid': '31171508', 'type': 'DERIVED', 'citation': 'Yin J, LaPlant B, Uy GL, Marcucci G, Blum W, Larson RA, Stone RM, Mandrekar SJ. Evaluation of event-free survival as a robust end point in untreated acute myeloid leukemia (Alliance A151614). Blood Adv. 2019 Jun 11;3(11):1714-1721. doi: 10.1182/bloodadvances.2018026112.'}, {'pmid': '30382485', 'type': 'DERIVED', 'citation': 'Stein E, Xie J, Duchesneau E, Bhattacharyya S, Vudumula U, Ndife B, Bonifacio G, Guerin A, Li N, Joseph G. Cost Effectiveness of Midostaurin in the Treatment of Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia in the United States. Pharmacoeconomics. 2019 Feb;37(2):239-253. doi: 10.1007/s40273-018-0732-4.'}, {'pmid': '28644114', 'type': 'DERIVED', 'citation': 'Stone RM, Mandrekar SJ, Sanford BL, Laumann K, Geyer S, Bloomfield CD, Thiede C, Prior TW, Dohner K, Marcucci G, Lo-Coco F, Klisovic RB, Wei A, Sierra J, Sanz MA, Brandwein JM, de Witte T, Niederwieser D, Appelbaum FR, Medeiros BC, Tallman MS, Krauter J, Schlenk RF, Ganser A, Serve H, Ehninger G, Amadori S, Larson RA, Dohner H. Midostaurin plus Chemotherapy for Acute Myeloid Leukemia with a FLT3 Mutation. N Engl J Med. 2017 Aug 3;377(5):454-464. doi: 10.1056/NEJMoa1614359. Epub 2017 Jun 23.'}, {'pmid': '22627678', 'type': 'DERIVED', 'citation': 'Stone RM, Fischer T, Paquette R, Schiller G, Schiffer CA, Ehninger G, Cortes J, Kantarjian HM, DeAngelo DJ, Huntsman-Labed A, Dutreix C, del Corral A, Giles F. Phase IB study of the FLT3 kinase inhibitor midostaurin with chemotherapy in younger newly diagnosed adult patients with acute myeloid leukemia. Leukemia. 2012 Sep;26(9):2061-8. doi: 10.1038/leu.2012.115. Epub 2012 Apr 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined with or without midostaurin (also known as PKC412), to find out which is better. This research is being done because it is unknown whether the addition of midostaurin to chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been tested in over 400 patients and is being studied in a number of illnesses, including AML, colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells with the abnormal FLT3 gene.', 'detailedDescription': 'In this study, patients will receive either the experimental agent (midostaurin) or placebo combined with chemotherapy treatment. Patients are stratified according to FLT3 mutation status (internal tandem duplication \\[ITD\\] allelic ratio \\< 0.7 vs ITD allelic ratio ≥ 0.7 vs tandem kinase domain \\[TKD\\]). There are three parts to the study treatment: remission induction therapy, remission consolidation therapy and continuation therapy.\n\nRemission Induction Therapy:\n\n* Cytarabine 200 mg/m2/day by continuous intravenous infusion on days 1-7\n* Daunorubicin 60 mg/m2/day by intravenous push or short infusion on days 1-3\n* Midostaurin 50 mg (two 25 mg capsules) or placebo for midostaurin (2 capsules) twice a day by mouth on days 8-21\n* A bone marrow aspiration will be performed in all patients on Day 21 to determine the need for a second induction cycle.\n\nRemission Consolidation (Four Remission Consolidation Cycles):\n\n* High dose cytarabine 3000 mg/m2 will be given by intravenous infusion over 3 hours every 12 hours on days 1, 3 and 5. Serial neurologic evaluation will be performed before and following the infusion of high-dose cytarabine.\n* Dexamethasone 0.1% or other corticosteroid ophthalmic solution 2 drops to each eye once daily to begin 6-12 hours prior to the initiation of the cytarabine infusion and to continue for at least 24 hours after the last cytarabine dose.\n* Midostaurin 50 mg (two 25 mg capsules) or placebo for midostaurin (2 capsules) twice a day by mouth on days 8-21\n\nMidostaurin/Placebo Continuation Therapy:\n\n* Midostaurin 50 mg (two 25 mg capsules) or placebo for midostaurin (2 capsules) by mouth twice a day for 28 days. Each cycle will be 28 days in length. Continuation therapy with midostaurin/placebo will continue until relapse or for 12 cycles maximum.\n\nThe primary and secondary objectives of this study are:\n\nPrimary objective:\n\n* To determine if the addition of midostaurin to daunorubicin/cytarabine induction, high-dose cytarabine consolidation, and continuation therapy improves overall survival (OS) in both the mutant FLT3-ITD and FLT3-TKD AML patients\n\nSecondary objectives:\n\n* To compare the overall survival (OS) in the two groups using an analysis in which patients who receive a stem cell transplant are censored at the time of transplant\n* To compare the complete response (CR) rate between the two treatment groups\n* To compare the event-free survival (EFS) between the two treatment groups\n* To compare the disease free survival (DFS) of the two treatment groups\n* To compare the disease free survival rate one year after completion of the continuation phase of the two groups\n* To assess the toxicity of the experimental combination\n* To describe the interaction between treatment outcome and pretreatment characteristics such as age, performance status, white blood cell (WBC) count, morphology, cytogenetics, and molecular and pharmacodynamic features\n* To assess the population pharmacokinetics (popPK) of midostaurin and its two major metabolites (CGP52421 and CGP62221). The potential association(s) between PK exposure and FLT3 status, OS, EFS and clinical response will be explored\n\nThere is a pharmacokinetic sub-study (CALGB 60706) within CALGB 10603. This embedded companion study must be offered to all patients enrolled on CALGB 10603, although patients may opt not to participate in CALGB 60706.\n\nAfter study entry, patients are followed periodically for up to 10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "1. Documentation of Disease:\n\n * Unequivocal diagnosis of AML ( \\> 20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia). Patients with neurologic symptoms suggestive of CNS leukemia are recommended to have a lumbar puncture. Patients whose CSF is positive for AML blasts are not eligible.\n * Documented FLT3 mutation (ITD or point mutation), determined by analysis in a protocol- designated FLT3 screening laboratory.\n2. Age Requirement:\n\n * Age ≥ 18 and \\< 60 years\n3. Prior Therapy:\n\n * No prior chemotherapy for leukemia or myelodysplasia with the following exceptions:\n\n * emergency leukapheresis\n * emergency treatment for hyperleukocytosis with hydroxyurea for ≤ 5 days\n * cranial RT for CNS leukostasis (one dose only)\n * growth factor/cytokine support\n * AML patients with a history of antecedent myelodysplasia (MDS) remain eligible for treatment on this trial, but must not have had prior cytotoxic therapy (e.g., azacitidine or decitabine)\n * Patients who have developed therapy related AML after prior RT or chemotherapy for another cancer or disorder are not eligible.\n4. Cardiac Function: Patients with symptomatic congestive heart failure are not eligible.\n5. Initial Laboratory Value: Total bilirubin \\< 2.5 x ULN (Upper Limit of Normal)\n6. Pregnancy and Nursing Status:\n\n * Non-pregnant and non-nursing due to the unknown teratogenic potential of midostaurin in humans, pregnant or nursing patients may not be enrolled.\n * Women of childbearing potential must have a negative serum or urine pregnancy test within a sensitivity of at least 50 mIU/mL within 16 days prior to registration.\n * Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or commit to TWO acceptable methods of birth control:\n\n * one highly effective method (eg, IUD, hormonal (non-oral contraceptive), tubal ligation, or partner's vasectomy) and\n * one additional effective method (e.g., latex condom, diaphragm or cervical cap)\n * The two acceptable methods of birth control must be used AT THE SAME TIME, before beginning midostaurin/placebo therapy and continuing for 12 weeks after completion of all therapy.\n * Note that oral contraceptives are not considered a high effective method because of the possibility of a drug interaction with midostaurin.\n * Women of childbearing potential is defined as a sexually active mature woman who has not undergone a hysterectomy or who has not had menses at any time in the preceding 24 consecutive months.\n * Men must agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking midostaurin/placebo and for 12 weeks after therapy is stopped, even if they have undergone a successful vasectomy."}, 'identificationModule': {'nctId': 'NCT00651261', 'briefTitle': 'Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND #101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML)', 'orgStudyIdInfo': {'id': 'CALGB-10603'}, 'secondaryIdInfos': [{'id': 'CALGB-10603'}, {'id': 'EUDRACT-2006-006852-37'}, {'id': 'CDR0000590404', 'type': 'REGISTRY', 'domain': 'Phyisician Data Query'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Induction and consolidation chemotherapy plus midostaurin', 'description': 'Patients will receive a standard combination of chemotherapy drugs during remission induction therapy that includes cytarabine, daunorubicin, and the experimental drug midostaurin. Depending on the outcome of remission induction treatment, there may be a decision to discontinue the study treatment or a second remission induction cycle may be given. If remission induction therapy is successfully completed, patients will receive four courses of high-dose cytarabine consolidation chemotherapy plus dexamethasone together with the experimental drug midostaurin. All patients will undergo a bone marrow aspiration (and perhaps a biopsy) after the final course of remission consolidation chemotherapy. If the patient continues to respond to the treatment, the patient will receive continuation therapy with midostaurin for twelve (12) months.', 'interventionNames': ['Drug: cytarabine', 'Drug: daunorubicin', 'Drug: midostaurin', 'Drug: dexamethasone acetate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Induction and consolidation chemotherapy plus placebo', 'description': 'Patients will receive a standard combination of chemotherapy drugs during remission induction therapy that includes cytarabine, daunorubicin, and placebo. Depending on the outcome of remission induction treatment, there may be a decision to discontinue the study treatment or a second remission induction cycle may be given. If remission induction therapy is successfully completed, patients will receive four courses of high-dose cytarabine consolidation chemotherapy plus dexamethasone together with placebo. All patients will undergo a bone marrow aspiration (and perhaps a biopsy) after the final course of remission consolidation chemotherapy. If the patient continues to respond to the treatment, the patient will receive continuation therapy with placebo for twelve (12) months.', 'interventionNames': ['Drug: cytarabine', 'Drug: daunorubicin', 'Other: placebo', 'Drug: dexamethasone acetate']}], 'interventions': [{'name': 'cytarabine', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Induction and consolidation chemotherapy plus midostaurin', 'Induction and consolidation chemotherapy plus placebo']}, {'name': 'daunorubicin', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Induction and consolidation chemotherapy plus midostaurin', 'Induction and consolidation chemotherapy plus placebo']}, {'name': 'midostaurin', 'type': 'DRUG', 'description': 'Given orally', 'armGroupLabels': ['Induction and consolidation chemotherapy plus midostaurin']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Given orally', 'armGroupLabels': ['Induction and consolidation chemotherapy plus placebo']}, {'name': 'dexamethasone acetate', 'type': 'DRUG', 'description': 'ocular medication administration', 'armGroupLabels': ['Induction and consolidation chemotherapy plus midostaurin', 'Induction and consolidation chemotherapy plus placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Cancer Research Center at University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aurora Presbyterian Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80301-9019', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Community Hospital', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80933', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Penrose Cancer Center at Penrose Hospital', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'St. Anthony Central Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Porter Adventist Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Presbyterian - 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