Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT00024102
Status:
COMPLETED
Last Update Posted:
2016-08-12
First Post:
2001-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'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': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hyman.muss@gmail.com', 'title': 'Hyman Muss, MD', 'organization': 'University of North Carolina'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Reported at the end of each cycle while patients were receiving protocol therapy.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Chemotherapy (CMF)', 'description': 'CMF: cyclophosphamide (100 mg/m\\^2 orally days 1-14)+ MTX (40 mg/m\\^2 by IV days 1 and 8) + 5-FU (600 mg/m\\^2 by IV days 1 and 8) repeated every 28 days for 6 cycles', 'otherNumAtRisk': 131, 'otherNumAffected': 121, 'seriousNumAtRisk': 131, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Standard Chemotherapy (AC)', 'description': 'AC: Cyclophosphamide (600 mg/m\\^2 by IV on day 1)+ doxorubicin (60 mg/m\\^2 by IV on day 1) repeated every 21 days for 4 cycles', 'otherNumAtRisk': 181, 'otherNumAffected': 168, 'seriousNumAtRisk': 181, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'Capecitabine', 'description': 'Capecitabine (2000 mg/m\\^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles', 'otherNumAtRisk': 299, 'otherNumAffected': 279, 'seriousNumAtRisk': 299, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 158, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 293, 'numAffected': 112}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 199, 'numAffected': 67}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Lymphatics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 35, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 44, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Transfusion: pRBCs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Flashing vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Watering eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 108, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 52, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 276, 'numAffected': 138}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 61, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 89, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 117, 'numAffected': 71}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 151, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 201, 'numAffected': 105}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 185, 'numAffected': 102}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Rectal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Typhlitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 40, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 48, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 34, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 299, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 321, 'numAffected': 129}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 504, 'numAffected': 162}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Gait abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'General symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hepatobiliary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Biliary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Infection with grade 3 or 4 neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Infection with unknown ANC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Infection without neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 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count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Serum albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Serum calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Serum glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Serum magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Serum potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Serum sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Ischemia cerebrovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Rash/Dermatitis BMT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Vaginal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hand-and-foot syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Rash desquamating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Peripheral arterial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relapse-free Survival Rates at 2.4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Chemotherapy', 'description': 'Patient/Physician choice of:\n\nCMF: cyclophosphamide (100 mg/m\\^2 orally days 1-14)+ MTX (40 mg/m\\^2 by IV days 1 and 8) + 5-FU (600 mg/m\\^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR\n\nAC: Cyclophosphamide (600 mg/m\\^2 by IV on day 1)+ doxorubicin (60 mg/m\\^2 by IV on day 1) repeated every 21 days for 4 cycles'}, {'id': 'OG001', 'title': 'Capecitabine', 'description': 'Capecitabine (2000 mg/m\\^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.'}], 'classes': [{'title': 'Relapse, first occurrence', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Alive without relapse', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.09', 'ciLowerLimit': '1.38', 'ciUpperLimit': '3.17', 'pValueComment': 'Multivariate proportional hazards regression used to test for an arm effect was adjusted for tumor size, number of lymph nodes and hormone-receptor status. A priori formal monitoring for futility and noninferiority was planned at accrual milestones', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The primary measure of efficacy was the hazard ratio for disease recurrence or death in the capecitabine group as compared with the standard chemotherapy group. Capecitabine would be considered noninferior to standard chemotherapy if the hazard ratio was greater than 0.8046. (With the use of a 5-year landmark for descriptive purposes, this ratio corresponds to a 5-year rate of relapse-free survival of 60% for standard chemotherapy and 53% for capecitabine.)'}], 'paramType': 'NUMBER', 'timeFrame': 'randomization until date of first event, or date last known to be event free if no event was reported (up to 5 years)', 'description': 'Percentage of participants who were alive and relapse-free at time of analysis were counted as "Alive without relapse" at 2.4 years. Participants who had a first local recurrence, first distant metastasis or death from any cause were counted as "relapse, first occurrence". These rates were estimated using the Kaplan Meier method', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'RFS used the intent-to-treat approach'}, {'type': 'SECONDARY', 'title': 'Overall Survival Rate at 2.4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Chemotherapy', 'description': 'Patient/Physician choice of:\n\nCMF: cyclophosphamide (100 mg/m\\^2 orally days 1-14)+ MTX (40 mg/m\\^2 by IV days 1 and 8) + 5-FU (600 mg/m\\^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR\n\nAC: Cyclophosphamide (600 mg/m\\^2 by IV on day 1)+ doxorubicin (60 mg/m\\^2 by IV on day 1) repeated every 21 days for 4 cycles'}, {'id': 'OG001', 'title': 'Capecitabine', 'description': 'Capecitabine (2000 mg/m\\^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '1.11', 'ciUpperLimit': '3.08', 'pValueComment': 'Multivariate proportional hazards regression used to test for an arm effect was adjusted for tumor size, number of lymph nodes and hormone-receptor status. There is no adjustment for multiple comparisons.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Time from registration to death (up to 15 years)', 'description': 'Percentage of patients who were alive at 2.4 years. This rate was estimated using the Kaplan Meier method.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OS used the intent-to-treat approach.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Chemotherapy (CMF)', 'description': 'CMF: cyclophosphamide (100 mg/m\\^2 orally days 1-14)+ MTX (40 mg/m\\^2 by IV days 1 and 8) + 5-FU (600 mg/m\\^2 by IV days 1 and 8) repeated every 28 days for 6 cycles'}, {'id': 'OG001', 'title': 'Standard Chemotherapy (AC)', 'description': 'AC: Cyclophosphamide (600 mg/m\\^2 by IV on day 1)+ doxorubicin (60 mg/m\\^2 by IV on day 1) repeated every 21 days for 4 cycles'}, {'id': 'OG002', 'title': 'Capecitabine', 'description': 'Capecitabine (2000 mg/m\\^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Reported during protocol treatment after each cycle', 'description': 'The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity.\n\nGrade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Chemotherapy', 'description': 'Patient/Physician choice of:\n\nCMF: cyclophosphamide (100 mg/m\\^2 orally days 1-14)+ MTX (40 mg/m\\^2 by IV days 1 and 8) + 5-FU (600 mg/m\\^2 by IV days 1 and 8) repeated every 28 days for 6 cycles\n\nOR\n\nAC: Cyclophosphamide (600 mg/m\\^2 by IV on day 1)+ doxorubicin (60 mg/m\\^2 by IV on day 1) repeated every 21 days for 4 cycles'}, {'id': 'FG001', 'title': 'Capecitabine', 'description': 'Capecitabine (2000 mg/m\\^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '326'}, {'groupId': 'FG001', 'numSubjects': '307'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '326'}, {'groupId': 'FG001', 'numSubjects': '307'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was an intergroup study led by the CALGB. Between September 2001 and December 2006, 633 participants were recruited.', 'preAssignmentDetails': 'All participants recruited were randomized with equal probability to one of two treatment arms. Randomization was initially stratified by age and performance score. In 2006 tumoral HER2 status was added as a third stratification factor.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '633', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Chemotherapy', 'description': 'Patient/Physician choice of:\n\nCMF: cyclophosphamide (100 mg/m\\^2 orally days 1-14)+ MTX (40 mg/m\\^2 by IV days 1 and 8) + 5-FU (600 mg/m\\^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR\n\nAC: Cyclophosphamide (600 mg/m\\^2 by IV on day 1)+ doxorubicin (60 mg/m\\^2 by IV on day 1) repeated every 21 days for 4 cycles'}, {'id': 'BG001', 'title': 'Capecitabine', 'description': 'Capecitabine (2000 mg/m\\^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '65-69 years', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}]}, {'title': '>=80 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '326', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '633', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '326', 'groupId': 'BG000'}, {'value': '302', 'groupId': 'BG001'}, {'value': '628', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ECOG Performance Status', 'classes': [{'title': '0 or 1 (fully active or minimal symptoms)', 'categories': [{'measurements': [{'value': '317', 'groupId': 'BG000'}, {'value': '295', 'groupId': 'BG001'}, {'value': '612', 'groupId': 'BG002'}]}]}, {'title': '2 (symptoms, but active > 50% of the time)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).', 'unitOfMeasure': 'participants'}, {'title': 'HER2 Status', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '246', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '478', 'groupId': 'BG002'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 633}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '2001-09-13', 'resultsFirstSubmitDate': '2012-11-20', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-21', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse-free Survival Rates at 2.4 Years', 'timeFrame': 'randomization until date of first event, or date last known to be event free if no event was reported (up to 5 years)', 'description': 'Percentage of participants who were alive and relapse-free at time of analysis were counted as "Alive without relapse" at 2.4 years. Participants who had a first local recurrence, first distant metastasis or death from any cause were counted as "relapse, first occurrence". These rates were estimated using the Kaplan Meier method'}], 'secondaryOutcomes': [{'measure': 'Overall Survival Rate at 2.4 Years', 'timeFrame': 'Time from registration to death (up to 15 years)', 'description': 'Percentage of patients who were alive at 2.4 years. This rate was estimated using the Kaplan Meier method.'}, {'measure': 'Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.', 'timeFrame': 'Reported during protocol treatment after each cycle', 'description': 'The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity.\n\nGrade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '19702447', 'type': 'BACKGROUND', 'citation': 'Pal SK, Mortimer J. Adjuvant chemotherapy for older adults with breast cancer: making the standard a standard. Womens Health (Lond). 2009 Sep;5(5):481-4. doi: 10.2217/whe.09.43.'}, {'pmid': '20368559', 'type': 'RESULT', 'citation': 'Partridge AH, Archer L, Kornblith AB, Gralow J, Grenier D, Perez E, Wolff AC, Wang X, Kastrissios H, Berry D, Hudis C, Winer E, Muss H. Adherence and persistence with oral adjuvant chemotherapy in older women with early-stage breast cancer in CALGB 49907: adherence companion study 60104. J Clin Oncol. 2010 May 10;28(14):2418-22. doi: 10.1200/JCO.2009.26.4671. Epub 2010 Apr 5.'}, {'type': 'RESULT', 'citation': 'Kornblith AB, Archer L, Lan L, et al.: Quality of life of early stage breast cancer patients 65 years old or older randomized to standard chemotherapy or capecitabine: A Cancer and Leukemia Group B Study (CALGB 49907). [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-5035, 2009.'}, {'pmid': '19439741', 'type': 'RESULT', 'citation': 'Muss HB, Berry DA, Cirrincione CT, Theodoulou M, Mauer AM, Kornblith AB, Partridge AH, Dressler LG, Cohen HJ, Becker HP, Kartcheske PA, Wheeler JD, Perez EA, Wolff AC, Gralow JR, Burstein HJ, Mahmood AA, Magrinat G, Parker BA, Hart RD, Grenier D, Norton L, Hudis CA, Winer EP; CALGB Investigators. Adjuvant chemotherapy in older women with early-stage breast cancer. N Engl J Med. 2009 May 14;360(20):2055-65. doi: 10.1056/NEJMoa0810266.'}, {'type': 'RESULT', 'citation': 'Muss HB, Berry DL, Cirrincione C, et al.: Standard chemotherapy (CMF or AC) versus capecitabine in early-stage breast cancer (BC) patients aged 65 and older: results of CALGB/CTSU 49907. [Abstract] J Clin Oncol 26 (Suppl 15): A-507, 2008.'}, {'type': 'RESULT', 'citation': 'Partridge AH, Archer LE, Kornblith AB, et al.: CALGB 60104: adherence with adjuvant capecitabine among women age 65 and older with early stage breast cancer treated on CALGB 49907. [Abstract] J Clin Oncol 26 (Suppl 15): A-6542, 2008.'}, {'pmid': '34037241', 'type': 'DERIVED', 'citation': 'Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.'}, {'pmid': '31339827', 'type': 'DERIVED', 'citation': 'Muss HB, Polley MC, Berry DA, Liu H, Cirrincione CT, Theodoulou M, Mauer AM, Kornblith AB, Partridge AH, Dressler LG, Cohen HJ, Kartcheske PA, Perez EA, Wolff AC, Gralow JR, Burstein HJ, Mahmood AA, Sutton LM, Magrinat G, Parker BA, Hart RD, Grenier D, Hurria A, Jatoi A, Norton L, Hudis CA, Winer EP, Carey L. Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial. J Clin Oncol. 2019 Sep 10;37(26):2338-2348. doi: 10.1200/JCO.19.00647. Epub 2019 Jul 24.'}, {'pmid': '31034595', 'type': 'DERIVED', 'citation': 'Magnuson A, Lei L, Gilmore N, Kleckner AS, Lin FV, Ferguson R, Hurria A, Wittink MN, Esparaz BT, Giguere JK, Misleh J, Bautista J, Mohile SG, Janelsins MC. Longitudinal Relationship Between Frailty and Cognition in Patients 50 Years and Older with Breast Cancer. J Am Geriatr Soc. 2019 May;67(5):928-936. doi: 10.1111/jgs.15934.'}, {'pmid': '29602735', 'type': 'DERIVED', 'citation': 'Gajra A, McCall L, Muss HB, Cohen HJ, Jatoi A, Ballman KV, Partridge AH, Sutton L, Parker BA, Magrinat G, Klepin HD, Lafky JM, Hurria A. The preference to receive chemotherapy and cancer-related outcomes in older adults with breast cancer CALGB 49907 (Alliance). J Geriatr Oncol. 2018 May;9(3):221-227. doi: 10.1016/j.jgo.2018.02.003. Epub 2018 Mar 28.'}, {'pmid': '29233548', 'type': 'DERIVED', 'citation': 'Morrison VA, McCall L, Muss HB, Jatoi A, Cohen HJ, Cirrincione CT, Ligibel JA, Lafky JM, Hurria A. The impact of actual body weight-based chemotherapy dosing and body size on adverse events and outcome in older patients with breast cancer: Results from Cancer and Leukemia Group B (CALGB) trial 49907 (Alliance A151436). J Geriatr Oncol. 2018 May;9(3):228-234. doi: 10.1016/j.jgo.2017.11.007. Epub 2017 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer.\n\nPURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the effectiveness of adjuvant chemotherapy comprising standard cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin and cyclophosphamide (AC) vs oral capecitabine, in terms of disease-free and overall survival, in elderly women with operable adenocarcinoma of the breast.\n* Compare the quality of life and physical functioning of patients treated with these regimens.\n* Compare the toxicity of these regimens in these patients.\n* Evaluate the adherence of older patients to an oral chemotherapy regimen.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (65 to 69 vs 70 to 80 vs over 80), performance status (0-1 vs 2), and HER2 status (positive vs negative vs unknown). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients with insufficient left ventricular ejection fraction (LVEF) are assigned to group A. Patients with normal LVEF are assigned to group A or B based on physician/patient choice.\n\n * Group A (CMF): Patients receive oral cyclophosphamide (CTX) daily on days 1-14 and methotrexate IV and fluorouracil IV on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.\n * Group B (AC): Patients receive doxorubicin IV and CTX IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nBeginning within 12 weeks after treatment in arm I or II, patients with estrogen or progesterone receptor-positive disease receive oral tamoxifen or an aromatase inhibitor daily for 5 years.\n\nBeginning 4-6 weeks after treatment in arm I or II, eligible patients who previously underwent breast conservation surgery undergo radiotherapy.\n\nQuality of life is assessed at baseline; at 6 weeks (group B), 9 weeks (arm II), or 12 weeks (group A); and then at 1, 12, 18, and 24 months after study.\n\nDrug adherence is assessed at 9 weeks during study (arm II).\n\nPatients are followed at 1 month, every 6 months for 2 years, and then annually for 15 years.\n\nPROJECTED ACCRUAL: A total of 600-1,800 patients (300-900 per treatment arm) will be accrued for this study within 2-6 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "1. Patients with operable, histologically confirmed adenocarcinoma of the female breast.\n2. TNM Stage per AJCC Cancer Staging Manual 6th edition:\n\n * T1-4 (Tumor size \\> 1 cm), N0, M0 or T1-4, N1-3, M0\n * Patients with bilateral, synchronous breast cancer are eligible as long as one primary tumor meets the criteria above.\n3. Patients with HER2/neu positive, negative or unknown disease are eligible for this trial.\n\n Patients whose tumors are HER2 positive by either immunohistochemistry 3+ staining or demonstrate gene amplification by FISH will be eligible to receive trastuzumab, as outlined in the protocol.\n4. Age 65 years or older\n5. Performance status 0-2 (Common Toxicity Criteria).\n6. Prior treatment:\n\n * Surgical resection -\n\n * All tumor should be removed by either a modified radical mastectomy or a lumpectomy. Patients must be registered ≤ 84 days from mastectomy or within 84 days of axillary dissection if patient's most extensive breast surgery was a breast sparing procedure.\n * Node dissection: Axillary node dissection is not required. Management of the axilla is at the discretion of the treating physician. There is no restriction on eligibility based on the number of nodes removed.\n * Mastectomy: There should be no evidence of gross or microscopic invasive tumor at the surgical resection margins noted in the final surgery or pathology reports for patients who have had a modified radical mastectomy. Patients with close margins (tumor \\< 1 mm from margin) are eligible.\n * Segmental mastectomy (lumpectomy): Although clear margins are preferable, DCIS or LCIS at the surgical resection margin will not render a patient who has undergone a segmental mastectomy ineligible for this study. Invasive tumor at the final resection margin will render a patient ineligible.\n * No prior chemotherapy for this malignancy.\n * Patients with a history of hypersensitivity to 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency are not eligible to participate.\n * Patients may receive up to four weeks of tamoxifen therapy for this malignancy and still be eligible for study entry. Patients who received tamoxifen or raloxifene for purposes of chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy should be discontinued before the patient is enrolled on this study.\n7. Required Initial Laboratory Data:\n\n * Granulocytes \\> 1,500/µl\n * Platelet count ≥100,000/µl\n * Calculated Creatinine Clearance \\> 30 mL/min\n * Total bilirubin ≤ ULN"}, 'identificationModule': {'nctId': 'NCT00024102', 'briefTitle': 'Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil - (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'CALGB-49907'}, 'secondaryIdInfos': [{'id': 'U10CA031946', 'link': 'https://reporter.nih.gov/quickSearch/U10CA031946', 'type': 'NIH'}, {'id': 'CAN-NCIC-MAC1'}, {'id': 'CDR0000068891', 'type': 'REGISTRY', 'domain': 'NCI Physician Data Query'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Chemotherapy', 'description': 'Patient/Physician choice of cyclophosphamide + MTX + 5-FU\n\nOR\n\nCyclophosphamide + doxorubicin', 'interventionNames': ['Drug: Standard Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Capecitabine', 'description': 'Treatment with capecitabine', 'interventionNames': ['Drug: capecitabine']}], 'interventions': [{'name': 'Standard Treatment', 'type': 'DRUG', 'otherNames': ['doxorubicin = adriamycin'], 'description': 'Cyclophosphamide 100 mg/sq m PO d 1-14 + MTX 40 mg/sq m IV push d 1 \\& 8 and 5-FU 600 mg/sq m IV push d 1 \\& 8 q 28 days for 6 cycles OR doxorubicin 60 mg/sq m IV d 1 + cyclophosphamide 600 mg/sq m IV d 1 q 21 d for 4 cycles', 'armGroupLabels': ['Standard Chemotherapy']}, {'name': 'capecitabine', 'type': 'DRUG', 'description': '2000 mg/sq m PO d 1-14, 7 day rest then repeat for a total of 6 cycles', 'armGroupLabels': ['Capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36652-2144', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Infirmary Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85259-5499', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85724-5024', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center at University of Arizona Health Sciences Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': "St. Joseph's Mercy Cancer Center", 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Glendale Memorial Hospital Comprehensive Cancer Center', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '94545', 'city': 'Hayward', 'state': 'California', 'country': 'United States', 'facility': 'Saint Rose Hospital', 'geoPoint': {'lat': 37.66882, 'lon': -122.0808}}, {'zip': '92093-0658', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90089-9181', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91328', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Leavey Cancer Center at Northridge Hospital Medical Center', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '94602', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Highland General Hospital at St. George's University School of Medicine", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center - Summit Campus', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'CCOP - Bay Area Tumor Institute', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94588', 'city': 'Pleasanton', 'state': 'California', 'country': 'United States', 'facility': 'Valley Care Medical Center', 'geoPoint': {'lat': 37.66243, 'lon': -121.87468}}, {'zip': '93901', 'city': 'Salinas', 'state': 'California', 'country': 'United States', 'facility': 'Salinas Valley Memorial Hospital', 'geoPoint': {'lat': 36.67774, 'lon': -121.6555}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Office -Vandever Medical Office', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94806', 'city': 'San Pablo', 'state': 'California', 'country': 'United States', 'facility': 'Doctors Medical Center - San Pablo Campus', 'geoPoint': {'lat': 37.96215, 'lon': -122.34553}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Memorial Hospital', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Eastern Connecticut Hematology and Oncology Associates', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '19901', 'city': 'Dover', 'state': 'Delaware', 'country': 'United States', 'facility': 'Kent General Hospital at Bayhealth Medical Center', 'geoPoint': {'lat': 39.15817, 'lon': -75.52437}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'CCOP - 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