Viewing Study NCT00500292

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Ignite Creation Date: 2025-12-24 @ 3:46 PM
Ignite Modification Date: 2025-12-29 @ 4:41 PM
Study NCT ID: NCT00500292
Status: COMPLETED
Last Update Posted: 2018-01-25
First Post: 2007-07-03
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of 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'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C452423', 'term': 'vandetanib'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'title': 'Trial Transparency Team', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Vandetanib 100 mg', 'description': 'vandetanib 100 mg plus FOLFOX', 'otherNumAtRisk': 32, 'otherNumAffected': 31, 'seriousNumAtRisk': 32, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Vandetanib 300 mg', 'description': 'vandetanib 300 mg plus FOLFOX', 'otherNumAtRisk': 35, 'otherNumAffected': 32, 'seriousNumAtRisk': 35, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Placebo', 'description': 'placebo plus FOLFOX', 'otherNumAtRisk': 37, 'otherNumAffected': 35, 'seriousNumAtRisk': 37, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Epigastric Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Gingival Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Electrocardiogram Qt Prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Peripheral Sensory Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dermatitis Acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Palmar-Plantar Erythrodysaesthesia Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Photosensitivity Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pigmentation Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 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The only additional mandatory tumour assessment visit is at the point of data cut-off (5 March 2008 +/-3 days)', 'description': 'Number of patients with objective disease progression or death (by any cause in the absence of objective progression)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colorectal', 'cancer', 'zactima'], 'conditions': ['Colorectal', 'Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=344&filename=CSR-D4200C00047.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=344&filename=CSR-D4200C00047.pdf', 'label': 'CSR-D4200C00047.pdf'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed 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