Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT00399035
Status:
COMPLETED
Last Update Posted:
2016-12-28
First Post:
2006-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia and Montenegro']}, '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': 'C500926', 'term': 'cediranib'}, {'id': 'C410216', 'term': 'Folfox protocol'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D007262', 'term': 'Infusions, Intravenous'}, {'id': 'C519688', 'term': 'XELOX'}, {'id': 'D000069287', 'term': 'Capecitabine'}], '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'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D061605', 'term': 'Administration, Intravenous'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007263', 'term': 'Infusions, Parenteral'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cediranib 30mg', 'description': 'Cediranib 30mg/day + Folfox/Xelox', 'otherNumAtRisk': 214, 'otherNumAffected': 209, 'seriousNumAtRisk': 214, 'seriousNumAffected': 94}, {'id': 'EG001', 'title': 'Cediranib 20mg', 'description': 'Cediranib 20mg/day + Folfox/Xelox', 'otherNumAtRisk': 500, 'otherNumAffected': 485, 'seriousNumAtRisk': 500, 'seriousNumAffected': 204}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo + Folfox/Xelox', 'otherNumAtRisk': 358, 'otherNumAffected': 341, 'seriousNumAtRisk': 358, 'seriousNumAffected': 105}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 139}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 84}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 138}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 75}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 39}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 43}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 8}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 346}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 165}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 256}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 169}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 230}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 126}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 134}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 78}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 118}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 85}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 78}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 200}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 104}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 76}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 19}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Platelet Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 229}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 125}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Peripheral Sensory Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 141}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 89}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 85}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neuropathy Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 77}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 64}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 27}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 35}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Palmar-Plantar Erythrodysaesthesia Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 123}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 57}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Skin Hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 500, 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{'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 226}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 41}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 18}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ureteric Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urethral Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary Bladder Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 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'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lung Infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pulmonary Artery Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Aortic Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Femoral Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Peripheral Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Peripheral Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vena Cava Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cediranib 20 mg', 'description': 'Cediranib 20 mg/day + FOLFOX/XELOX'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + FOLFOX/XELOX'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '12.1'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '11.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.', 'description': 'RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression \\[non-PD\\]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation.The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.'}, {'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cediranib 20 mg', 'description': 'Cediranib 20 mg/day + FOLFOX/XELOX'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + FOLFOX/XELOX'}], 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '36.1'}, {'value': '18.9', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '28.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through to date of death upto and including data cut off date of 21/03/10', 'description': 'Number of months from randomisation to the date of death from any cause', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. 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Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Non-target lesions Complete Response (CR) Disappearance of all non-target lesi', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.'}, {'type': 'SECONDARY', 'title': 'Best Percentage Change in Tumour Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cediranib 20 mg', 'description': 'Cediranib 20 mg/day + FOLFOX/XELOX'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + FOLFOX/XELOX'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.49', 'spread': '28.139', 'groupId': 'OG000'}, {'value': '-40.61', 'spread': '31.992', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through to date of death upto and including data cut off date of 21/03/10', 'description': 'Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions', 'unitOfMeasure': 'Percentage [change in tumour size (mm) ]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cediranib 20 mg', 'description': 'Cediranib 20 mg/day + FOLFOX/XELOX'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + FOLFOX/XELOX'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '12.7'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '11.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Treatment period from initial response up until data cut-off date of 21/03/10', 'description': 'Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.'}, {'type': 'SECONDARY', 'title': 'Rate of Resection of Liver Metastases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cediranib 20 mg', 'description': 'Cediranib 20 mg/day + FOLFOX/XELOX'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + FOLFOX/XELOX'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-randomisation until end of study', 'description': 'Number of patients undergoing liver resection, based on patients with liver disease at baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.'}, {'type': 'SECONDARY', 'title': 'Time to Wound Healing Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cediranib 20 mg', 'description': 'Cediranib 20 mg/day + FOLFOX/XELOX'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo + FOLFOX/XELOX'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '93'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '114'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-randomisation until end of study', 'description': 'Number of days from post-randomisation surgery until wound healing complications', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cediranib 20 mg/Day', 'description': '\\[Cediranib 20mg/day+FOLFOX/XELOX\\].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.'}, {'id': 'FG001', 'title': 'Cediranib 30 mg/Day', 'description': '\\[Cediranib 30mg/day+FOLFOX/XELOX\\].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.'}, {'id': 'FG002', 'title': 'Placebo', 'description': '\\[Placebo +FOLFOX/XELOX\\].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '502'}, {'groupId': 'FG001', 'numSubjects': '216'}, {'groupId': 'FG002', 'numSubjects': '358'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '313'}, {'groupId': 'FG001', 'numSubjects': '158'}, {'groupId': 'FG002', 'numSubjects': '252'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '141'}, {'groupId': 'FG002', 'numSubjects': '234'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Incorrect enrolment/eligib not fulfilled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Severe non-compliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Randomised=full analysis set: Cediranib 20mg=502, Placebo=358; Safety set: Cediranib 20mg=500, Cediranib 30mg=214, Placebo=358', 'preAssignmentDetails': "Cediranib 30 mg discontinued following Phase II, Cediranib 20 mg chosen dose for comparing with Placebo.\n\n1254 patients enrolled to the study, 1076 recieved study treatment; 2 patients lost for Cediranib 20 mg/day, and 2 patients lost for Cediranib 30 mg/day.The 4 patients that didn't receive drug are intentionally included."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}, {'value': '1076', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cediranib 20 mg', 'description': 'Cediranib 20 mg + FOLFOX/XELOX'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo + FOLFOX/XELOX'}, {'id': 'BG002', 'title': 'Cediranib 30 mg', 'description': 'Cediranib 30 mg/day + FOLFOX/XELOX'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '11.14', 'groupId': 'BG000'}, {'value': '57.2', 'spread': '11.63', 'groupId': 'BG001'}, {'value': '59.4', 'spread': '10.69', 'groupId': 'BG002'}, {'value': '57.6', 'spread': '11.34', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Age at informed consent', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '442', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '299', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '634', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender at informed consent', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1254}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'dispFirstSubmitDate': '2011-04-06', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-07', 'studyFirstSubmitDate': '2006-11-13', 'dispFirstSubmitQcDate': '2011-04-06', 'resultsFirstSubmitDate': '2012-03-29', 'studyFirstSubmitQcDate': '2006-11-13', 'dispFirstPostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-28', 'studyFirstPostDateStruct': {'date': '2006-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.', 'description': 'RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression \\[non-PD\\]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.'}, {'measure': 'Overall Survival', 'timeFrame': 'Baseline through to date of death upto and including data cut off date of 21/03/10', 'description': 'Number of months from randomisation to the date of death from any cause'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate', 'timeFrame': 'Baseline through to date of death upto and including data cut off date of 21/03/10', 'description': 'Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.RECIST criteria defined as follows: Target lesions Complete Response(CR)Disappearance of all target lesions Partial Response (PR).At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Non-target lesions Complete Response (CR) Disappearance of all non-target lesi'}, {'measure': 'Best Percentage Change in Tumour Size', 'timeFrame': 'Baseline through to date of death upto and including data cut off date of 21/03/10', 'description': 'Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions'}, {'measure': 'Duration of Response', 'timeFrame': 'Treatment period from initial response up until data cut-off date of 21/03/10', 'description': 'Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies.'}, {'measure': 'Rate of Resection of Liver Metastases', 'timeFrame': 'Post-randomisation until end of study', 'description': 'Number of patients undergoing liver resection, based on patients with liver disease at baseline'}, {'measure': 'Time to Wound Healing Complications', 'timeFrame': 'Post-randomisation until end of study', 'description': 'Number of days from post-randomisation surgery until wound healing complications'}]}, 'conditionsModule': {'keywords': ['Colorectal Cancer', 'Cediranib', 'RECENTIN'], 'conditions': ['Metastatic Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '23510802', 'type': 'DERIVED', 'citation': 'Smith JC, Brooks L, Hoff PM, McWalter G, Dearden S, Morgan SR, Wilson D, Robertson JD, Jurgensmeier JM. KRAS mutations are associated with inferior clinical outcome in patients with metastatic colorectal cancer, but are not predictive for benefit with cediranib. Eur J Cancer. 2013 Jul;49(10):2424-32. doi: 10.1016/j.ejca.2013.02.023. Epub 2013 Mar 16.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=424&filename=CSR-D8480C00051.pdf', 'label': 'CSR-D8480C00051.pdf'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written Informed Consent\n* Carcinoma of the colon or rectum\n* One or more measurable lesions\n\nExclusion Criteria:\n\n* Adjuvant/neoadjuvant therapy within 6-12 months of study entry\n* Untreated unstable brain or meningeal metastases\n* Specific laboratory ranges\n* Specific cardiovascular problems\n* Participation in other trials within 30 days'}, 'identificationModule': {'nctId': 'NCT00399035', 'acronym': 'HORIZON II', 'briefTitle': 'Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Double-blind, Phase III Study to Compare the Efficacy and Safety of Cediranib (AZD2171, RECENTIN™) When Added to 5 Fluorouracil, Leucovorin and Oxaliplatin (FOLFOX) or Capecitabine and Oxaliplatin (XELOX) With the Efficacy and Safety of Placebo When Added to FOLFOX or XELOX in Patients With Previously Untreated Metastatic Colorectal Cancer.', 'orgStudyIdInfo': {'id': 'D8480C00051'}, 'secondaryIdInfos': [{'id': 'EUDRACT No 2006-001194-14'}, {'id': 'HORIZON II'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'FOLFOX + placebo Cediranib', 'description': 'FOLFOX + placebo Cediranib', 'interventionNames': ['Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)', 'Drug: Cediranib Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Xelox + placebo Cediranib', 'description': 'Xelox + placebo Cediranib', 'interventionNames': ['Drug: XELOX (Capecitabine and Oxaliplatin)', 'Drug: Cediranib Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'FOLFOX + Cediranib', 'description': 'FOLFOX + Cediranib', 'interventionNames': ['Drug: Cediranib', 'Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)']}, {'type': 'EXPERIMENTAL', 'label': 'XELOX + Cediranib', 'description': 'XELOX + Cediranib', 'interventionNames': ['Drug: Cediranib', 'Drug: XELOX (Capecitabine and Oxaliplatin)']}], 'interventions': [{'name': 'Cediranib', 'type': 'DRUG', 'otherNames': ['AZD2171', 'RECENTIN™'], 'description': 'oral tablet', 'armGroupLabels': ['FOLFOX + Cediranib', 'XELOX + Cediranib']}, {'name': 'FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)', 'type': 'DRUG', 'otherNames': ['Other Names:', '5-FU', 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