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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 4:51 PM

Ignite Modification Date: 2025-12-28 @ 10:15 AM

Study NCT ID: NCT00265850

Status: COMPLETED

Last Update Posted: 2020-05-07

First Post: 2005-12-14

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'C410216', 'term': 'Folfox protocol'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'C480833', 'term': 'IFL protocol'}, {'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Venook@cc.ucsf.edu', 'title': 'Alan Venook, M.D.', 'organization': 'Alliance for Clinical Trials in Oncology'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: FOLFOX or FOLFIRI + Bevacizumab', 'description': 'Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.\n\nFOLFOX or: Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours\n\nFOLFIRI: Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.', 'otherNumAtRisk': 559, 'otherNumAffected': 531, 'seriousNumAtRisk': 559, 'seriousNumAffected': 98}, {'id': 'EG001', 'title': 'Arm B: FOLFOX or FOLFIRI + Cetuximab', 'description': 'Patients receive cetuximab 400mg/m\\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.\n\nFOLFOX or: Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours\n\nFOLFIRI: Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.', 'otherNumAtRisk': 578, 'otherNumAffected': 548, 'seriousNumAtRisk': 578, 'seriousNumAffected': 111}], 'otherEvents': [{'term': 'Blood disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 161, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 145, 'numAffected': 83}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Lymphatic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Cardiac pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Conduction disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Nodal arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Ventricular trigeminy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'External ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hearing test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Middle ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Cushingoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 23, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Dry eye syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Extraocular muscle paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Eyelid function disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 10, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Watering eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 377, 'numAffected': 189}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 327, 'numAffected': 186}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Anal exam abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Anal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Anal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Anal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Colonic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Colonic hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Colonic obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 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'sourceVocabulary': 'MedDRA 5'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Ileal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Arterial injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Carbon monoxide diffusing capacity decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Cardiac troponin I increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Leukocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 38, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 43, 'numAffected': 36}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Serum cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Serum glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Serum magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 12, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Serum phosphate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Serum potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Serum potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Serum sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Serum sodium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Ischemia cerebrovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hand-and-foot syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Rash desquamating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 559, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 578, 'numEvents': 39, 'numAffected': 22}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 5'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'OG000'}, {'value': '578', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: FOLFOX or FOLFIRI + Bevacizumab', 'description': 'Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.\n\nFOLFOX or: Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours\n\nFOLFIRI: Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.'}, {'id': 'OG001', 'title': 'Arm B: FOLFOX or FOLFIRI + Cetuximab', 'description': 'Patients receive cetuximab 400mg/m\\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.\n\nFOLFOX or: Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours\n\nFOLFIRI: Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.'}, {'id': 'OG002', 'title': 'Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab', 'description': 'Patients receive cetuximab 400mg/m\\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\\^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.\n\nFOLFOX or: Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours\n\nFOLFIRI: Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '31.2'}, {'value': '30.0', 'groupId': 'OG001', 'lowerLimit': '27.5', 'upperLimit': '32.8'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.01', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 5 years post-treatment', 'description': 'Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible KRAS wild type patients that began treatment were included in this endpoint.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'OG000'}, {'value': '578', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: FOLFOX or FOLFIRI + Bevacizumab', 'description': 'Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.\n\nFOLFOX or: Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours\n\nFOLFIRI: Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.'}, {'id': 'OG001', 'title': 'Arm B: FOLFOX or FOLFIRI + Cetuximab', 'description': 'Patients receive cetuximab 400mg/m\\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.\n\nFOLFOX or: Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours\n\nFOLFIRI: Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.'}, {'id': 'OG002', 'title': 'Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab', 'description': 'Patients receive cetuximab 400mg/m\\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\\^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.\n\nFOLFOX or: Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours\n\nFOLFIRI: Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '11.1'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '11.3'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.08', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 5 years post-treatment', 'description': 'PFS will be measured from study entry until first documented progression or death from any cause. Time to event distributions will be estimated using the Kaplan-Meier method. PFS will be compared between Arm A and Arm B.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible KRAS wild type patients were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure', 'timeFrame': 'Up to 5 years post-treatment', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Duration of Tumor Response', 'timeFrame': 'Up to 5 years post-treatment', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: FOLFOX or FOLFIRI + Bevacizumab', 'description': 'Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.\n\nFOLFOX or: Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours\n\nFOLFIRI: Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.'}, {'id': 'FG001', 'title': 'Arm B: FOLFOX or FOLFIRI + Cetuximab', 'description': 'Patients receive cetuximab 400mg/m\\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.\n\nFOLFOX or: Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours\n\nFOLFIRI: Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.'}, {'id': 'FG002', 'title': 'Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab', 'description': 'Patients receive cetuximab 400mg/m\\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\\^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.\n\nFOLFOX or: Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours\n\nFOLFIRI: Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '899'}, {'groupId': 'FG001', 'numSubjects': '902'}, {'groupId': 'FG002', 'numSubjects': '533'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '899'}, {'groupId': 'FG001', 'numSubjects': '902'}, {'groupId': 'FG002', 'numSubjects': '533'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'From 5/2005 to 9/2009, patients were randomized 1:1:1 to Arms A, B and C. Study was amended in 2009 to include only KRAS wild type patients; then Arm C was closed based on data showing no benefit from chemo with the combination of Bevacizumab and an EGFR antibody. Thereafter, only KRAS wild type patients were randomized 1:1 to Arm A and B.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '578', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1137', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: FOLFOX or FOLFIRI + Bevacizumab', 'description': 'Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.\n\nFOLFOX or: Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours\n\nFOLFIRI: Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.'}, {'id': 'BG001', 'title': 'Arm B: FOLFOX or FOLFIRI + Cetuximab', 'description': 'Patients receive cetuximab 400mg/m\\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.\n\nFOLFOX or: Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours\n\nFOLFIRI: Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.'}, {'id': 'BG002', 'title': 'Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab', 'description': 'Patients receive cetuximab 400mg/m\\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\\^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.\n\nFOLFOX or: Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours\n\nFOLFIRI: Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '21.8', 'upperLimit': '85'}, {'value': '59.2', 'groupId': 'BG001', 'lowerLimit': '20.8', 'upperLimit': '89.5'}, {'value': '59.1', 'groupId': 'BG003', 'lowerLimit': '20.8', 'upperLimit': '89.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '440', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '348', 'groupId': 'BG000'}, {'value': '349', 'groupId': 'BG001'}, {'value': '697', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '527', 'groupId': 'BG000'}, {'value': '546', 'groupId': 'BG001'}, {'value': '1073', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'During the trial, it was learned that KRAS mutation predicted for lack of efficacy of EGFR antibodies; also studies showed no benefit from chemo combined with both Bevacizumab and an EGFR antibody. The trial was amended to 2 arms limited to KRAS wild type patients. Only confirmed and consented KRAS wild type patients were analyzed.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2334}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-28', 'studyFirstSubmitDate': '2005-12-14', 'resultsFirstSubmitDate': '2017-03-13', 'studyFirstSubmitQcDate': '2005-12-14', 'lastUpdatePostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-13', 'studyFirstPostDateStruct': {'date': '2005-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Up to 5 years post-treatment', 'description': 'Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to 5 years post-treatment', 'description': 'PFS will be measured from study entry until first documented progression or death from any cause. Time to event distributions will be estimated using the Kaplan-Meier method. PFS will be compared between Arm A and Arm B.'}, {'measure': 'Time to Treatment Failure', 'timeFrame': 'Up to 5 years post-treatment'}, {'measure': 'Duration of Tumor Response', 'timeFrame': 'Up to 5 years post-treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent colon cancer', 'stage III colon cancer', 'stage III rectal cancer', 'stage IV colon cancer', 'recurrent rectal cancer', 'stage IV rectal cancer', 'adenocarcinoma of the colon', 'adenocarcinoma of the rectum'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Schrag D, Naughton M, Kesselheim A, et al.: Clinical trial participants' strategies for coping with prescription drug costs: A companion study to CALGB 80405. [Abstract] J Clin Oncol 27 (Suppl 15): A-9503, 2009."}, {'pmid': '17553204', 'type': 'RESULT', 'citation': 'Venook AP, Blanke CD, Niedzwiecki D, Lenz HJ, Taylor JR, Hollis DR, Sutherland S, Goldberg RM. Revisiting the Cancer and Leukemia Group B/Southwest Oncology Group 80405 Trial: a phase III trial of chemotherapy and biologic agents for patients with untreated advanced colorectal adenocarcinoma. Clin Colorectal Cancer. 2007 May;6(7):536-8. doi: 10.3816/CCC.2007.n.021. No abstract available.'}, {'pmid': '16356309', 'type': 'RESULT', 'citation': 'Venook AP, Blanke CD, Niedzwiecki D, Lenz HJ, Taylor JR, Hollis DR, Sutherland S, Goldberg RM. Cancer and Leukemia Group B/Southwest Oncology Group trial 80405: a phase III trial of chemotherapy and biologics for patients with untreated advanced colorectal adenocarcinoma. Clin Colorectal Cancer. 2005 Nov;5(4):292-4. doi: 10.3816/ccc.2005.n.043. No abstract available.'}, {'pmid': '38457761', 'type': 'DERIVED', 'citation': 'Battaglin F, Ou FS, Qu X, Hochster HS, Niedzwiecki D, Goldberg RM, Mayer RJ, Ashouri K, Zemla TJ, Blanke CD, Venook AP, Kabbarah O, Lenz HJ, Innocenti F. HER2 Gene Expression Levels Are Predictive and Prognostic in Patients With Metastatic Colorectal Cancer Enrolled in CALGB/SWOG 80405. J Clin Oncol. 2024 Jun 1;42(16):1890-1902. doi: 10.1200/JCO.23.01507. Epub 2024 Mar 8.'}, {'pmid': '36067452', 'type': 'DERIVED', 'citation': 'Raghav K, Ou FS, Venook AP, Innocenti F, Sun R, Lenz HJ, Kopetz S. Acquired Genomic Alterations on First-Line Chemotherapy With Cetuximab in Advanced Colorectal Cancer: Circulating Tumor DNA Analysis of the CALGB/SWOG-80405 Trial (Alliance). J Clin Oncol. 2023 Jan 20;41(3):472-478. doi: 10.1200/JCO.22.00365. Epub 2022 Sep 6.'}, {'pmid': '31548349', 'type': 'DERIVED', 'citation': "Yuan C, Sato K, Hollis BW, Zhang S, Niedzwiecki D, Ou FS, Chang IW, O'Neil BH, Innocenti F, Lenz HJ, Blanke CD, Goldberg RM, Venook AP, Mayer RJ, Fuchs CS, Meyerhardt JA, Ng K. Plasma 25-Hydroxyvitamin D Levels and Survival in Patients with Advanced or Metastatic Colorectal Cancer: Findings from CALGB/SWOG 80405 (Alliance). Clin Cancer Res. 2019 Dec 15;25(24):7497-7505. doi: 10.1158/1078-0432.CCR-19-0877. Epub 2019 Sep 23."}, {'pmid': '31408415', 'type': 'DERIVED', 'citation': "Guercio BJ, Zhang S, Ou FS, Venook AP, Niedzwiecki D, Lenz HJ, Innocenti F, O'Neil BH, Shaw JE, Polite BN, Hochster HS, Atkins JN, Goldberg RM, Sato K, Ng K, Van Blarigan E, Mayer RJ, Blanke CD, O'Reilly EM, Fuchs CS, Meyerhardt JA. Associations of Physical Activity With Survival and Progression in Metastatic Colorectal Cancer: Results From Cancer and Leukemia Group B (Alliance)/SWOG 80405. J Clin Oncol. 2019 Oct 10;37(29):2620-2631. doi: 10.1200/JCO.19.01019. Epub 2019 Aug 13."}, {'pmid': '31042420', 'type': 'DERIVED', 'citation': 'Lenz HJ, Ou FS, Venook AP, Hochster HS, Niedzwiecki D, Goldberg RM, Mayer RJ, Bertagnolli MM, Blanke CD, Zemla T, Qu X, Wirapati P, Tejpar S, Innocenti F, Kabbarah O. Impact of Consensus Molecular Subtype on Survival in Patients With Metastatic Colorectal Cancer: Results From CALGB/SWOG 80405 (Alliance). J Clin Oncol. 2019 Aug 1;37(22):1876-1885. doi: 10.1200/JCO.18.02258. Epub 2019 May 1.'}, {'pmid': '28632865', 'type': 'DERIVED', 'citation': "Venook AP, Niedzwiecki D, Lenz HJ, Innocenti F, Fruth B, Meyerhardt JA, Schrag D, Greene C, O'Neil BH, Atkins JN, Berry S, Polite BN, O'Reilly EM, Goldberg RM, Hochster HS, Schilsky RL, Bertagnolli MM, El-Khoueiry AB, Watson P, Benson AB 3rd, Mulkerin DL, Mayer RJ, Blanke C. Effect of First-Line Chemotherapy Combined With Cetuximab or Bevacizumab on Overall Survival in Patients With KRAS Wild-Type Advanced or Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA. 2017 Jun 20;317(23):2392-2401. doi: 10.1001/jama.2017.7105."}], 'seeAlsoLinks': [{'url': 'https://nctn-data-archive.nci.nih.gov/', 'label': 'Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.'}]}, 'descriptionModule': {'briefSummary': 'PURPOSE: This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer.\n\nRATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with cetuximab and/or bevacizumab in treating patients with colorectal cancer.', 'detailedDescription': 'OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to physician-selected chemotherapy (FOLFOX or FOLFIRI), prior adjuvant chemotherapy (yes vs no), and prior pelvic radiotherapy (yes vs no). Patients were randomized to 1 of 3 treatment arms.\n\nPrimary Objective:\n\n* To determine if the addition of cetuximab to FOLFIRI or FOLFOX chemotherapy prolongs survival compared to FOLFIRI or FOLFOX with bevacizumab in patients with untreated, advanced or metastatic colorectal cancer who have K-ras wild type tumors.\n\nSecondary Objectives:\n\n* To evaluate response, progression-free survival (PFS), time to treatment failure (TTF), and duration of response (DR) among patients with unresectable advanced metastatic colon cancer treated with bevacizumab or cetuximab in addition to chemotherapy with FOLFIRI or FOLFOX\n* To evaluate toxicity and, in particular, 60-day mortality among patients with unresectable advanced metastatic colon cancer treated with bevacizumab or cetuximab in addition to chemotherapy with FOLFIRI or FOLFOX\n* To describe patients with unresectable locally advanced or metastatic colorectal cancer rendered "resectable" with chemotherapy\n\nThere are premedication guidelines that were established for patients assigned to receive cetuximab. All patients must be premedicated with diphenhydramine hydrochloride 50 mg (or a similar agent) IV prior to the first dose of cetuximab in an effort to prevent an infusion or hypersensitivity reaction. Premedication is also recommended prior to subsequent doses, but at the investigator\'s discretion the dose of diphenhydramine (or a similar agent) may be reduced. Pretreatment with acetaminophen may also be used.\n\nThere are bevacizumab administration instructions for patients for whom surgery is being contemplated or required. For patients for whom elective surgery is contemplated, bevacizumab is to be discontinued for at least 8 weeks prior to surgery. Bevacizumab may be resumed after at least 4 weeks following surgery. Patients who undergo complete resection of metastatic disease will discontinue protocol therapy and may receive further treatment at the treating physician\'s discretion. For patients for whom non-elective surgery is required, hold bevacizumab as long as possible prior to surgery and for at least 6 weeks following surgery.\n\nPatients received a minimum of two cycles of therapy. Patients were allowed to receive ancillary therapy per protocol. Treatment continued until disease progression, unacceptable toxicity, or surgery with curative intent as planned. After completion of study treatment, patients are followed up to 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "1. Locally Advanced or Metastatic Colorectal Cancer\n\n 1. Eligible patients must have histologically or cytologically documented adenocarcinoma of the colon or rectum. Patients must have either locally advanced (unresectable) or metastatic disease. Patients with resected primary tumors who have documented metastases are eligible. Documentation of residual disease by CT scan or surgeon's notes is required for all patients, and histologic confirmation of metastases is strongly encouraged.\n 2. Patients with a history of colorectal cancer treatment by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless:\n\n * Either an interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease or\n * The primary cancer was stage I. Clinicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.\n 3. At the time of randomization, the intent of this treatment must be indicated palliative or neoadjuvant chemotherapy with the potential for resection of all sites of metastatic disease.\n2. Only patients with a wildtype K-ras gene as determined by the laboratory at the SWOG Solid Tumor Repository or by a local CLIA-certified laboratory are eligible. Patients with a mutation in the K-ras gene are ineligible. All patients must have available for analysis of K-ras status at least one H and E slide and one paraffin block of the previously resected primary colorectal tumor and/or a tumor deposit. For patients registered and randomized based on local CLIA-certified laboratory results, SWOG analysis will be confirmatory only.\n3. Prior Treatment\n\n 1. No prior systemic treatment for advanced or metastatic colorectal cancer is allowed. Prior regional chemotherapy (eg, hepatic arterial infusion) is also not allowed.\n\n * Patients may have received prior adjuvant chemotherapy that included fluorouracil alone or in combination with fluorouracil and oxaliplatin or irinotecan (no more than 6 months); or radiation with radiosensitizing chemotherapy.\n * The last course of adjuvant chemotherapy must have concluded \\> 12 months prior to colorectal cancer recurrence.\n * Patients may have received neoadjuvant chemo-radiation with capecitabine or 5-fluorouracil.\n * Patients may not have received itraconazole or ketoconazole less than 4 weeks prior to randomization.\n * No prior exposure to any tyrosine kinase inhibitors or other agents (including protein products, monoclonal antibodies, antisense, etc.) that target VEGF or EGF receptors is allowed.\n * No prior treatment with bevacizumab or cetuximab.\n 2. Patients may not have had prior radiotherapy to greater than 25% of bone marrow.\n\n (Standard adjuvant rectal cancer chemoradiation will not exclude patient from protocol entry.) Radiation must have concluded ≥ 4 weeks prior to randomization.\n 3. Patients should have completed any major surgery ≥ 4 weeks from randomization. Patients must have completed any minor surgery ≥ 2 weeks prior to randomization. Patients must have fully recovered from the procedure. (Insertion of a vascular access device is not considered major or minor surgery.)\n4. No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years.\n5. For patients who are to receive FOLFIRI: No evidence of Gilbert's Syndrome or of homozygosity for the UGT1A1\\*28 allele.\n\n 1. Patients with Gilbert's Syndrome may have a greater risk of irinotecan toxicity due to the abnormal glucuronidation of SN-38. Evidence of Gilbert's Syndrome would include a prior finding of an isolated elevation of indirect bilirubin.\n 2. UGT1A1 genotyping is not required on this study. However, patients known to be homozygous for the UGT1A1\\*28 allele are not to receive FOLFIRI for this study. Patients with Gilbert's Syndrome or who are found to be homozygous for the UGT1A1 allele who will receive FOLFOX are eligible.\n6. No sensory peripheral neuropathy of ≥ grade 2 at baseline for patients who are to receive FOLFOX.\n7. No known central nervous system metastases or carcinomatous meningitis.\n8. No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.\n9. No pleural effusion or ascites that causes ≥ grade 2 dyspnea.\n10. No predisposing colonic or small bowel disorders in which the symptoms are uncontrolled as indicated by baseline pattern of \\> 3 watery or soft stools daily in patients without a colostomy or ileostomy. Patients with a colostomy or ileostomy may entered at investigator discretion.\n11. Patients must not have an uncontrolled seizure disorder, or active neurological disease.\n12. No current congestive heart failure (New York Heart Association Class II, III or IV)\n13. Patients with history of hypertension must be well controlled ( \\< 160/90) on a regimen of anti-hypertensive therapy.\n14. Patients on full-dose anticoagulation (eg, warfarin) are eligible provided that both of the following criteria are met:\n\n 1. The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or be on a stable dose of low molecular weight heparin.\n 2. The patient has no active bleeding or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices).\n15. Patients receiving anti-platelet agents are eligible. In addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible.\n16. No significant history of bleeding events or GI perforation:\n\n 1. Patients with a history of significant bleeding episodes (eg, hemoptysis, upper or lower GI bleeding ) within 6 months of randomization are not eligible unless the source of bleeding has been resected.\n 2. Patients with a history of GI perforation within 12 months of randomization are not eligible.\n17. No arterial thrombotic events within 6 months before randomization, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI). Patients with clinically significantly peripheral artery disease (eg, claudication on less than one block) or any other arterial thrombotic event are also ineligible.\n18. No serious or non-healing wound, ulcer or bone fracture\n19. Patients with known hypersensitivity to Chinese hamster ovary cell products or to recombinant human or murine antibodies are not eligible.\n20. Non-pregnant and not nursing:\n\n 1. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization.\n 2. DNA alkylating agents are known to be teratogenic, and the effects of irinotecan, oxaliplatin, 5-FU, bevacizumab, and cetuximab on a developing fetus at the recommended therapeutic doses are unknown.\n 3. Women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.\n 4. Postmenopausal is defined as amenorrhea ≥ 12 consecutive months or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level \\> 35 mIU/mL.\n 5. Women of child-bearing potential also include women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (eg, vasectomy), should be considered to be of child bearing potential.\n21. ECOG Performance Status of 0-1\n22. Age ≥ 18 years\n23. Required Initial Laboratory Values:\n\n 1. Granulocytes ≥ 1500 µL\n 2. Hemoglobin ≥ 9.0 grams/dL (patient may be transfused to meet this criterion)\n 3. Platelet count ≥ 100,000/µL\n 4. Creatinine ≤ 1.5 x Upper limits of normal\n 5. Bilirubin ≤ 1.5 mg/dL\n 6. Albumin ≥ 2.5 g/dL\n 7. Urinalysis ≤ 1 + protein\\*\n\n * \\*Patients discovered to have ≥ 2+ proteinuria at baseline must undergo a 24-hour urine collection that must demonstrate \\< 1 g of protein/24 hour or have a UPC \\< 1.0 to allow participation in the study."}, 'identificationModule': {'nctId': 'NCT00265850', 'briefTitle': 'Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'A Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU/ Leucovorin With Bevacizumab, or Cetuximab (C225), or With the Combination of Bevacizumab and Cetuximab for Patients With Untreated Metastatic Adenocarcinoma of the Colon or Rectum', 'orgStudyIdInfo': {'id': 'CALGB 80405'}, 'secondaryIdInfos': [{'id': 'U10CA037447', 'link': 'https://reporter.nih.gov/quickSearch/U10CA037447', 'type': 'NIH'}, {'id': 'CDR0000455161', 'type': 'OTHER', 'domain': 'Physician Data Query'}, {'id': 'NCI-2009-00434', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trial Reporting Program Office'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A: FOLFOX or FOLFIRI + bevacizumab', 'description': 'Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.', 'interventionNames': ['Biological: bevacizumab', 'Drug: FOLFOX or', 'Drug: FOLFIRI']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: FOLFOX or FOLFIRI + cetuximab', 'description': 'Patients receive cetuximab 400mg/m\\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.', 'interventionNames': ['Biological: cetuximab', 'Drug: FOLFOX or', 'Drug: FOLFIRI']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: FOLFOX or FOLFIRI + cetuximab + bevacizumab', 'description': 'Patients receive cetuximab 400mg/m\\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\\^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.', 'interventionNames': ['Biological: bevacizumab', 'Biological: cetuximab', 'Drug: FOLFOX or', 'Drug: FOLFIRI']}], 'interventions': [{'name': 'bevacizumab', 'type': 'BIOLOGICAL', 'description': 'Given IV', 'armGroupLabels': ['Arm A: FOLFOX or FOLFIRI + bevacizumab', 'Arm C: FOLFOX or FOLFIRI + cetuximab + bevacizumab']}, {'name': 'cetuximab', 'type': 'BIOLOGICAL', 'description': 'Given IV', 'armGroupLabels': ['Arm B: FOLFOX or FOLFIRI + cetuximab', 'Arm C: FOLFOX or FOLFIRI + cetuximab + bevacizumab']}, {'name': 'FOLFOX or', 'type': 'DRUG', 'otherNames': ['Eloxatin (oxaliplatin), leucovorin (folinic acid) and 5-Fluorouracil (5-FU)'], 'description': 'Patients receive oxaliplatin 85 mg/m\\^2 IV infused over two hours followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus, then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours', 'armGroupLabels': ['Arm A: FOLFOX or FOLFIRI + bevacizumab', 'Arm B: FOLFOX or FOLFIRI + cetuximab', 'Arm C: FOLFOX or FOLFIRI + cetuximab + bevacizumab']}, {'name': 'FOLFIRI', 'type': 'DRUG', 'otherNames': ['CPT-11 (irinotecan), leucovorin (folinic acid), and 5-Fluorouracil (5-FU)'], 'description': 'Patients receive irinotecan 180 mg/m\\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\\^2 IV over 2 hours followed by 5-FU 400 mg/m\\^2 IV bolus following leucovorin then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours.', 'armGroupLabels': ['Arm A: FOLFOX or FOLFIRI + bevacizumab', 'Arm B: FOLFOX or FOLFIRI + cetuximab', 'Arm C: FOLFOX or FOLFIRI + cetuximab + bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Providence Cancer Center at Providence Hospital', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Regional Hospital Cancer Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Providence Cancer Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '72903', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Hembree Mercy Cancer Center at St. Edward Mercy Medical Center', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'NEA Medical Center - 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