Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-04-14 @ 8:30 AM
Study NCT ID:
NCT01228734
Status:
COMPLETED
Last Update Posted:
2020-01-28
First Post:
2010-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@emdgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Communication Center', 'organization': 'Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Safety Follow up (assessed up to 333 weeks)', 'description': 'Modified safety population included all subjects with RAS wild type tumor status who received any study treatment (cetuximab, oxaliplatin or 5-FU/FA). Subjects were analyzed as treated.', 'eventGroups': [{'id': 'EG000', 'title': 'Cetuximab + FOLFOX-4', 'description': 'Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m\\^2 at 5 mg/min and 250 mg/m\\^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m\\^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m\\^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.', 'otherNumAtRisk': 194, 'deathsNumAtRisk': 194, 'otherNumAffected': 194, 'seriousNumAtRisk': 194, 'deathsNumAffected': 157, 'seriousNumAffected': 42}, {'id': 'EG001', 'title': 'FOLFOX-4', 'description': 'Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m\\^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m\\^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.', 'otherNumAtRisk': 199, 'deathsNumAtRisk': 199, 'otherNumAffected': 194, 'seriousNumAtRisk': 199, 'deathsNumAffected': 173, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'BONE MARROW FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 151}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 146}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 149}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 102}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ABDOMINAL DISTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HAEMATOCHEZIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'MOUTH ULCERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 92}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HYPERBILIRUBINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 21}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'LIVER INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'DRUG HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 15}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'PARONYCHIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'INFUSION RELATED REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 54}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 58}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'BLOOD ALBUMIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'BLOOD ALKALINE PHOSPHATASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'BLOOD BILIRUBIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'BLOOD LACTATE DEHYDROGENASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'GAMMA-GLUTAMYLTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HAEMOGLOBIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 42}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'NEUTROPHIL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'PLATELET COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'WEIGHT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'WHITE BLOOD CELL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 60}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HYPOALBUMINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HYPOCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HYPOPHOSPHATAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HYPOAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'NEUROTOXICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'DERMATITIS ACNEIFORM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'SKIN FISSURES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 38}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HYPOMAGNESAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HYPOPROTEINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'BONE MARROW FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'FEBRILE NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'THROMBOCYTOPENIC PURPURA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ATRIAL FLUTTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'VENTRICULAR TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'RETINAL DETACHMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ANAL FISTULA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'INCARCERATED INGUINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'INTESTINAL PERFORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'LARGE INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'SMALL INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'MULTI-ORGAN FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'SUDDEN DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'CHOLECYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HEPATIC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HYPERBILIRUBINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'JAUNDICE CHOLESTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'DRUG HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ANAL ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'EPIDIDYMITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'SEPTIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'SKIN INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'STAPHYLOCOCCAL BACTERAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'STAPHYLOCOCCAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HAEMOGLOBIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'TYPE 2 DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'CEREBRAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HEPATIC ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'SUICIDE ATTEMPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'URETERIC OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'DYSPNOEA AT REST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'AXILLARY VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'JUGULAR VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'PHLEBITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'SUBCLAVIAN VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'VENOUS THROMBOSIS LIMB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'THROMBOCYTOPENIC PURPURA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'LARGE INTESTINE POLYP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'INFUSION SITE INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'COLON CANCER METASTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab + FOLFOX-4', 'description': 'Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m\\^2 at 5 mg/min and 250 mg/m\\^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m\\^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m\\^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'FOLFOX-4', 'description': 'Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m\\^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m\\^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '10.9'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '7.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.629', 'ciLowerLimit': '0.498', 'ciUpperLimit': '0.794', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 333 weeks', 'description': 'PFS was defined as the duration (in months) from randomization until the first progressive disease (PD) observation as assessed by the Independent Review Committee (IRC) according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.0, or death due to any cause when death occurred within 90 days of randomization or the last tumor assessment, whichever was later. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of the target lesions, taking as references the smallest sum LD since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab + FOLFOX-4', 'description': 'Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m\\^2 at 5 mg/min and 250 mg/m\\^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m\\^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m\\^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'FOLFOX-4', 'description': 'Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m\\^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m\\^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '16.3', 'upperLimit': '23.5'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '14.8', 'upperLimit': '19.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 333 weeks', 'description': 'OS was defined as the time (in months) from randomization to death. For subjects who were still alive at the analysis data cut-off date or who lost to follow-up, survival was censored at the last recorded date that the subject was known to be alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab + FOLFOX-4', 'description': 'Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m\\^2 at 5 mg/min and 250 mg/m\\^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m\\^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m\\^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'FOLFOX-4', 'description': 'Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m\\^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m\\^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'groupId': 'OG000', 'lowerLimit': '59.2', 'upperLimit': '72.9'}, {'value': '40.5', 'groupId': 'OG001', 'lowerLimit': '33.6', 'upperLimit': '47.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 333 weeks', 'description': 'The Best ORR was defined as the percentage of subjects having achieved complete response (CR) or partial response (PR) according to RECIST version 1.0 as determined by the IRC. CR: defined as disappearance of all target and all non-target lesions and no new lesions. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions and no new lesions.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure (TTF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab + FOLFOX-4', 'description': 'Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m\\^2 at 5 mg/min and 250 mg/m\\^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m\\^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m\\^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'FOLFOX-4', 'description': 'Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m\\^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m\\^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '9.3'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '6.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 333 weeks', 'description': "TTF was defined as time from randomization to date of the first occurrence of radiologically confirmed PD as determined by IRC, Clinical PD according to the Investigator's assessment (if radiological confirmation of PD by IRC was unavailable), discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death within 90 days of last tumor assessment or randomization. Subjects without event were censored on the date of last tumor assessment.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Curative Surgery of Liver Metastases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab + FOLFOX-4', 'description': 'Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m\\^2 at 5 mg/min and 250 mg/m\\^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m\\^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m\\^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'FOLFOX-4', 'description': 'Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m\\^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m\\^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.'}], 'classes': [{'title': 'Subjects with liver surgery', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with liver surgery outcome: R0', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with liver surgery outcome: R1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with liver surgery outcome: R2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Subjects not evaluable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 333 weeks', 'description': 'The number of subjects who underwent liver metastatic surgery after start of treatment and the outcome of surgery with respect to residual tumor after surgery (R0, R1, R2, not evaluable) were summarized. In case of resection of more than one metastasis, the worst outcome of surgery defined the overall status of a subject. R0 = No residual tumor after resection (all lesions resected completely); R1 = Metastases not resected completely with microscopic residual lesions; and R2 = Metastases not resected completely with macroscopic residual lesions.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized. Here "Number Analyzed" signifies those subjects who were evaluable for the specified categories.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cetuximab + FOLFOX4', 'description': 'Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-fluorouracil (5-FU)/folinic acid (FA). Cetuximab was always administered every 7 days with an initial dose of 400 milligram per square meter (mg/m\\^2) at 5 milligram per minute (mg/min) and 250 mg/m\\^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m\\^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m\\^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.'}, {'id': 'FG001', 'title': 'FOLFOX4', 'description': 'Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m\\^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m\\^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '204'}]}, {'type': 'Modified Intent-to-treat Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'Modified Safety Population', 'achievements': [{'comment': 'One subject was randomized to FOLFOX-4 group but received cetuximab + FOLFOX-4 treatment instead', 'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Randomized, but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study was planned to enroll subjects with Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type (wt) tumors.Following modification of approved EU indication of cetuximab,a decision made to amend study population from subjects with KRAS wt tumors to those with RAS wt tumors. All efficacy/safety analysis based on subjects with RAS wt tumor.', 'preAssignmentDetails': 'First subject first visit/last subject last visit: 30 September 2010/31 Jan 2018. A total of 553 subjects were enrolled in the trial. 504 subjects were randomized in the study, of which 397 were with RAS wt tumors. Participant Flow is presented for the subjects with RAS wt tumors.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '393', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cetuximab + FOLFOX-4', 'description': 'Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m\\^2 at 5 mg/min and 250 mg/m\\^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m\\^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m\\^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.'}, {'id': 'BG001', 'title': 'FOLFOX-4', 'description': 'Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m\\^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m\\^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '55.1', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '54.9', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified intent-to-treat (MITT) population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 553}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-16', 'studyFirstSubmitDate': '2010-09-09', 'resultsFirstSubmitDate': '2017-01-13', 'studyFirstSubmitQcDate': '2010-10-25', 'lastUpdatePostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-13', 'studyFirstPostDateStruct': {'date': '2010-10-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) Time', 'timeFrame': 'Baseline up to 333 weeks', 'description': 'PFS was defined as the duration (in months) from randomization until the first progressive disease (PD) observation as assessed by the Independent Review Committee (IRC) according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.0, or death due to any cause when death occurred within 90 days of randomization or the last tumor assessment, whichever was later. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of the target lesions, taking as references the smallest sum LD since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) Time', 'timeFrame': 'Baseline up to 333 weeks', 'description': 'OS was defined as the time (in months) from randomization to death. For subjects who were still alive at the analysis data cut-off date or who lost to follow-up, survival was censored at the last recorded date that the subject was known to be alive.'}, {'measure': 'Best Overall Response Rate (ORR)', 'timeFrame': 'Baseline up to 333 weeks', 'description': 'The Best ORR was defined as the percentage of subjects having achieved complete response (CR) or partial response (PR) according to RECIST version 1.0 as determined by the IRC. CR: defined as disappearance of all target and all non-target lesions and no new lesions. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions and no new lesions.'}, {'measure': 'Time to Treatment Failure (TTF)', 'timeFrame': 'Baseline up to 333 weeks', 'description': "TTF was defined as time from randomization to date of the first occurrence of radiologically confirmed PD as determined by IRC, Clinical PD according to the Investigator's assessment (if radiological confirmation of PD by IRC was unavailable), discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death within 90 days of last tumor assessment or randomization. Subjects without event were censored on the date of last tumor assessment."}, {'measure': 'Number of Subjects With Curative Surgery of Liver Metastases', 'timeFrame': 'Baseline up to 333 weeks', 'description': 'The number of subjects who underwent liver metastatic surgery after start of treatment and the outcome of surgery with respect to residual tumor after surgery (R0, R1, R2, not evaluable) were summarized. In case of resection of more than one metastasis, the worst outcome of surgery defined the overall status of a subject. R0 = No residual tumor after resection (all lesions resected completely); R1 = Metastases not resected completely with microscopic residual lesions; and R2 = Metastases not resected completely with macroscopic residual lesions.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Metastatic colorectal cancer', 'RAS wild type', 'Cetuximab', 'First line treatment', 'First occurrence of metastatic colorectal cancer in Chinese subjects with RAS wildtype', 'status'], 'conditions': ['Metastatic Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '32051297', 'type': 'DERIVED', 'citation': 'Wang H, Huang L, Gao P, Zhu Z, Ye W, Ding H, Fang L. Cost-effectiveness analysis of cetuximab combined with chemotherapy as a first-line treatment for patients with RAS wild-type metastatic colorectal cancer based on the TAILOR trial. BMJ Open. 2020 Feb 12;10(2):e030738. doi: 10.1136/bmjopen-2019-030738.'}, {'pmid': '31849531', 'type': 'DERIVED', 'citation': 'Bai L, Zhang P, Zhou K, Liao W, Li Q. Cost-Effectiveness Analysis of First-Line Cetuximab Plus Leucovorin, Fluorouracil, and Oxaliplatin (FOLFOX-4) versus FOLFOX-4 in Patients with RAS Wild-Type Metastatic Colorectal Cancer. Cancer Manag Res. 2019 Dec 12;11:10419-10426. doi: 10.2147/CMAR.S219318. eCollection 2019.'}, {'pmid': '30199311', 'type': 'DERIVED', 'citation': 'Qin S, Li J, Wang L, Xu J, Cheng Y, Bai Y, Li W, Xu N, Lin LZ, Wu Q, Li Y, Yang J, Pan H, Ouyang X, Qiu W, Wu K, Xiong J, Dai G, Liang H, Hu C, Zhang J, Tao M, Yao Q, Wang J, Chen J, Eggleton SP, Liu T. Efficacy and Tolerability of First-Line Cetuximab Plus Leucovorin, Fluorouracil, and Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 in Patients With RAS Wild-Type Metastatic Colorectal Cancer: The Open-Label, Randomized, Phase III TAILOR Trial. J Clin Oncol. 2018 Oct 20;36(30):3031-3039. doi: 10.1200/JCO.2018.78.3183. Epub 2018 Sep 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess whether the progression free survival (PFS) time with FOLFOX-4 plus cetuximab is longer than that with FOLFOX-4 alone as first-line treatment for mCRC in Chinese subjects with RAS wild-type tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed written informed consent (first and second)\n* Chinese with Chinese citizenship\n* Male or female subjects greater than or equal to (\\>=) 18 years of age\n* Medically accepted effective contraception if procreative potential exists (applicable for both male and female subjects until at least 90 days after the last dose of trial treatment)\n* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum\n* First occurrence of metastatic disease (not curatively resectable) RAS wild-type status in tumor tissue\n* At least one measurable lesion by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST (not in an irradiated area)\n* Life expectancy of at least 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at trial entry\n* White blood cell count \\>= 3 × 10x9/L with neutrophils \\>= 1.5 × 10x9/L, platelet count \\>= 100 × 10x9/L and hemoglobin \\>= 6.21 mmol/L (10 g/dL)\n* Total bilirubin \\<= 1.5 × upper limit of reference range\n* Aspartate transaminase (AST) and alanine transaminase (ALT) \\<= 2.5 × upper limit of reference range or \\<= 5 × upper reference range in subjects with liver metastasis\n* Serum creatinine \\<= 1.5 × upper limit of reference range\n* Recovery from relevant toxicity due to previous treatment before trial entry\n\nExclusion Criteria:\n\n* Previous chemotherapy for CRC except adjuvant treatment if terminated \\> 9 months (oxaliplatin-based chemotherapy) or \\> 6 months (non-oxaliplatin-based chemotherapy) before the start of treatment in this trial\n* Radiotherapy or surgery (excluding prior diagnostic biopsy) in the 30 days before trial treatment\n* Previous treatment with monoclonal antibody therapy, vascular endothelial growth factor (VEGF) pathway-targeting therapy, epidermal growth factor receptor (EGFR) pathway-targeting therapy, or other signal transduction inhibitors\n* History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation\n* Renal replacement therapy\n* Intake of any investigational medication within 30 days before trial entry\n* Concurrent chronic systemic immune therapy or hormone therapy except physiologic replacement\n* Granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) within 3 weeks of trial entry (these growth factors may be used during the trial thereafter)\n* Other non-permitted concomitant anticancer therapies\n* Known brain metastasis and/or leptomeningeal disease. Subjects with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis\n* Previous malignancy other than CRC in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 5 years, or left ventricular ejection fraction below the institutional range of normal on a baseline multiple gated acquisition scan or echocardiogram\n* Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease\n* Active clinically serious infections (\\> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0), including active tuberculosis\n* Known and declared history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C\n* Peripheral neuropathy \\> grade 1\n* Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such\n* Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, or liver failure\n* Known hypersensitivity or allergic reactions against any of the components of the trial treatments\n* Pregnancy (absence to be confirmed by serum β-human chorionic gonadotropin test) or breastfeeding\n* Ongoing alcohol or drug abuse\n* Presence of a medical or psychological condition that would not permit the subject to complete the trial or sign informed consent\n* Participation in another clinical trial within the past 30 days\n* Other significant disease that in the investigator's opinion should exclude the subject from the trial\n* Legal incapacity or limited legal capacity"}, 'identificationModule': {'nctId': 'NCT01228734', 'acronym': 'TAILOR', 'briefTitle': 'A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'An Open-label, Randomized, Controlled, Multicenter Phase III Trial to Compare Cetuximab in Combination With FOLFOX-4 Versus FOLFOX-4 Alone in the First Line Treatment of Metastatic Colorectal Cancer in Chinese Subjects With RAS Wild-type Status', 'orgStudyIdInfo': {'id': 'EMR62202-057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cetuximab + FOLFOX-4', 'description': 'Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-fluorouracil (5-FU)/folinic acid (FA). Cetuximab was always administered every 7 days with an initial dose of 400 milligram per square meter (mg/m\\^2) at 5 milligram per minute (mg/min) and 250 mg/m\\^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m\\^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m\\^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.', 'interventionNames': ['Drug: Cetuximab', 'Drug: Oxaliplatin', 'Drug: Folinic Acid', 'Drug: 5Fluorouracil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FOLFOX-4', 'description': 'Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m\\^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m\\^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Folinic Acid', 'Drug: 5Fluorouracil']}], 'interventions': [{'name': 'Cetuximab', 'type': 'DRUG', 'otherNames': ['Erbitux', 'C225'], 'description': 'Cetuximab was administered every 7 days at an initial dose of 400 milligram per square meter (mg/m\\^2) at 5 milligram per minute (mg/min) and 250 mg/m\\^2 at 10 mg/min for subsequent infusions until progression of disease, withdrawal of consent, or unacceptable toxicity to cetuximab.', 'armGroupLabels': ['Cetuximab + FOLFOX-4']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Oxaliplatin 85 mg/m\\^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.', 'armGroupLabels': ['Cetuximab + FOLFOX-4', 'FOLFOX-4']}, {'name': 'Folinic Acid', 'type': 'DRUG', 'description': 'FA 200 mg/m\\^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.', 'armGroupLabels': ['Cetuximab + FOLFOX-4', 'FOLFOX-4']}, {'name': '5Fluorouracil', 'type': 'DRUG', 'description': '5-FU as a bolus of 400 mg/m\\^2/day intravenously over 2-4 minutes followed by 600 mg/m\\^2/day infusion over 22 hours on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.', 'armGroupLabels': ['Cetuximab + FOLFOX-4', 'FOLFOX-4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350014', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Province Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '350025', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fuzhou General Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510405', 'city': 'Guangzhou', 'state': 'Guangdong', 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