Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-09 @ 8:16 PM
Study NCT ID:
NCT00700102
Status:
COMPLETED
Last Update Posted:
2015-07-30
First Post:
2008-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal 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': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Patients in the study who were randomized to receive bevacizumab could continue to receive bevacizumab following discontinuation of chemotherapy, thereby minimizing any potential bias introduced by differential follow-up time in the treatment arms.'}}, 'adverseEventsModule': {'timeFrame': 'First subject first visit to end of trial within 7.25 years', 'description': 'Safety Analysis Set was defined as all randomized patients who received any amount of study treatment, and were analyzed according to actual treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Chemotherapy', 'description': 'Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal', 'otherNumAtRisk': 409, 'otherNumAffected': 379, 'seriousNumAtRisk': 409, 'seriousNumAffected': 137}, {'id': 'EG001', 'title': 'Chemotherapy + Bevacizumab', 'description': 'Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal', 'otherNumAtRisk': 401, 'otherNumAffected': 382, 'seriousNumAtRisk': 401, 'seriousNumAffected': 130}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 333, 'numAffected': 177}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 471, 'numAffected': 233}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 294, 'numAffected': 170}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 340, 'numAffected': 178}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 162, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 188, 'numAffected': 119}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 91, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 126, 'numAffected': 89}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 96, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 120, 'numAffected': 82}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 47, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 69, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 31, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 44, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 263, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 246, 'numAffected': 106}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 126, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 154, 'numAffected': 94}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 72, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 136, 'numAffected': 76}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 61, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 92, 'numAffected': 66}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 159, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 246, 'numAffected': 112}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 102, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 124, 'numAffected': 69}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 62, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 110, 'numAffected': 53}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 93, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 58, 'numAffected': 41}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 139, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 179, 'numAffected': 78}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 99, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 94, 'numAffected': 46}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 67, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 98, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 47, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 58, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 29, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 53, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 40, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 85, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 92, 'numAffected': 71}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 68, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 96, 'numAffected': 50}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 88, 'numAffected': 70}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 48, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 40, 'numAffected': 36}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 35, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 42, 'numAffected': 35}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 99, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 105, 'numAffected': 79}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 32, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 34, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 33, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 29, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 72, 'numAffected': 47}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 29, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 39, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 38, 'numAffected': 37}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'seriousEvents': [{'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Colonic obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Enterovesical fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastrointestinal hopomotility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastrointestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastrointestinal toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Inguinal hernia, obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 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Cost-effectiveness analysis of continuing bevacizumab plus chemotherapy versus chemotherapy alone after first progression of metastatic colorectal cancer. Cancer Med. 2024 Jan;13(1):e6904. doi: 10.1002/cam4.6904. Epub 2024 Jan 8.'}, {'pmid': '23852309', 'type': 'DERIVED', 'citation': 'Kubicka S, Greil R, Andre T, Bennouna J, Sastre J, Van Cutsem E, von Moos R, Osterlund P, Reyes-Rivera I, Muller T, Makrutzki M, Arnold D; ML18147 study investigators including AIO, GERCOR, FFCD, UNICANCER GI, TTD, BGDO, GEMCAD, and AGMT groups. Bevacizumab plus chemotherapy continued beyond first progression in patients with metastatic colorectal cancer previously treated with bevacizumab plus chemotherapy: ML18147 study KRAS subgroup findings. Ann Oncol. 2013 Sep;24(9):2342-9. doi: 10.1093/annonc/mdt231. Epub 2013 Jul 12.'}, {'pmid': '23168366', 'type': 'DERIVED', 'citation': 'Bennouna J, Sastre J, Arnold D, Osterlund P, Greil R, Van Cutsem E, von Moos R, Vieitez JM, Bouche O, Borg C, Steffens CC, Alonso-Orduna V, Schlichting C, Reyes-Rivera I, Bendahmane B, Andre T, Kubicka S; ML18147 Study Investigators. Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol. 2013 Jan;14(1):29-37. doi: 10.1016/S1470-2045(12)70477-1. Epub 2012 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. 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