Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00154102
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Estonia', 'Israel']}, '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': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': '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': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'monika.foerster@merck.de', 'phone': '+496151729517', 'title': 'Monika Foerster/Clinical Trial Leader', 'organization': 'Merck Serono'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "A non-specific outcome measure 'Safety' was deleted from the entry in error. A replacement outcome was created. The outcome refers to adverse events."}}, 'adverseEventsModule': {'timeFrame': 'Time from first dose up to 30 days after the last dose of study treatment.', 'description': 'Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.', 'eventGroups': [{'id': 'EG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops.\n\nSafety population: includes all treated subjects.', 'otherNumAtRisk': 600, 'otherNumAffected': 593, 'seriousNumAtRisk': 600, 'seriousNumAffected': 263}, {'id': 'EG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops.\n\nSafety population: includes all treated subjects', 'otherNumAtRisk': 602, 'otherNumAffected': 591, 'seriousNumAtRisk': 602, 'seriousNumAffected': 204}], 'otherEvents': [{'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 272}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 249}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 120}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 127}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LYMPHOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 35}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 377}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 353}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 322}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 359}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 194}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 231}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 169}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 110}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 142}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 154}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 119}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 192}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 186}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 136}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 64}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 112}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MUCOSAL INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INJECTION SITE REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PARONYCHIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 52}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ANOREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 169}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 149}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPOMAGNESAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 55}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 55}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 40}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 45}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 53}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 59}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 32}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 270}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 224}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 229}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DERMATITIS ACNEIFORM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 146}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 30}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SKIN FISSURES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ACNE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NAIL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'EXFOLIATIVE RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SKIN TOXICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 36}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PHLEBITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'FEBRILE BONE MARROW APLASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'FEBRILE NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LYMPHOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 35}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PANCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PLATELET TOXICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ACUTE CORONARY SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ARRHYTHMIA SUPRAVENTRICULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ARTERIOSPASM CORONARY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CARDIAC ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CARDIAC FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CARDIAC FAILURE CONGESTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CARDIOGENIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 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'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CATHETER SITE INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CENTRAL LINE INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ERYSIPELAS', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SKIN INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'STAPHYLOCOCCAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'STAPHYLOCOCCAL SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VARICELLA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'WOUND INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ALCOHOL POISONING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ANASTOMOTIC STENOSIS', 'stats': [{'groupId': 'EG000', 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'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'FIBULA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'FRACTURED SACRUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HIP FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 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'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SUBDURAL HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VASCULAR ACCESS COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'C-REACTIVE PROTEIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HAEMOGLOBIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HEPATIC ENZYME INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LABORATORY TEST ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NEUTROPHIL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PLATELET COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'URINE ANALYSIS ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'WHITE BLOOD CELL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ANOREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CACHEXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DIABETIC KETOACIDOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ELECTROLYTE IMBALANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPERKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPOALBUMINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPOCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPOGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPOMAGNESAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LACTIC ACIDOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MALNUTRITION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'METABOLIC ACIDOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ORAL INTAKE REDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'JOINT SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BLADDER NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CANCER PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MALIGNANT NEOPLASM PROGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'METASTASES TO CENTRAL NERVOUS SYSTEM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'OVARIAN LOW MALIGNANT POTENTIAL TUMOUR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'TUMOUR ASSOCIATED FEVER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'TUMOUR HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CEREBRAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CEREBRAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'COMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'COORDINATION ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DEPRESSED LEVEL OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'EPILEPSY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HEMIPARESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LETHARGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LOSS OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SPINAL CORD COMPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VOCAL CORD PARALYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ACUTE CARDIO-VASCULAR INSUFFICIENCY', 'notes': 'An organ system was assigned to this adverse event as required for posting on Clinicaltrials.gov - the organ system was not assigned in the Clinical Study Report', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ACUTE GASTROENTERITIS', 'notes': 'An organ system was assigned to this adverse event as required for posting on Clinicaltrials.gov - the organ system was not assigned in the Clinical Study Report', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ACUTE PNEUMONIA', 'notes': 'An organ system was assigned to this adverse event as required for posting on Clinicaltrials.gov - the organ system was not assigned in the Clinical Study Report', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CIRCULATORY INSUFFICIENCY', 'notes': 'An organ system was assigned to this adverse event as required for posting on Clinicaltrials.gov - the organ system was not assigned in the Clinical Study Report', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INFECTION OF OSTEOSYNTHESIS IN RIGHT ANCLE', 'notes': 'An organ system was assigned to this adverse event as required for posting on Clinicaltrials.gov - the organ system was not assigned in the Clinical Study Report', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'THROMBUS//CLOT IN VEIN OF LEFT HAND CAUSING INFECTION', 'notes': 'An organ system was assigned to this adverse event as required for posting on Clinicaltrials.gov - the organ system was not assigned in the Clinical Study Report', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ABNORMAL BEHAVIOUR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CONFUSIONAL STATE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'EUPHORIC MOOD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MENTAL STATUS CHANGES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CALCULUS URETERIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CALCULUS URINARY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DYSURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HAEMATURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HAEMORRHAGE URINARY TRACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYDRONEPHROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NEPHROLITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'RENAL COLIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'URETERIC OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'URINARY RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BENIGN PROSTATIC HYPERPLASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VAGINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BRONCHOSPASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PLEURITIC PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ACNE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DERMATITIS ACNEIFORM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CATARACT OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'AXILLARY VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CIRCULATORY COLLAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INTERMITTENT CLAUDICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'JUGULAR VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PERIPHERAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PERIPHERAL OCCLUSIVE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PHLEBITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SUBCLAVIAN VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VENA CAVA THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VENOUS THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VENOUS THROMBOSIS LIMB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 602, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '599', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '9.4'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '9.0'}]}]}], 'analyses': [{'pValue': '0.0479', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.853', 'ciLowerLimit': '0.728', 'ciUpperLimit': '1.000', 'groupDescription': 'The study was planned with 633 progression events, in order to provide 80% power to test the null hypothesis of no difference in PFS time between treatment groups, assuming a hazard ratio (HR) of 0.8 of cetuximab + chemotherapy (CTX) over CTX alone. Significance level was fixed at 5%. The two-sided stratified log-rank test was employed, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and Karnovsky Performance Scale (KPS):\\<80 vs. ≥80)', 'statisticalMethod': 'Stratified log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.\n\nOnly deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis on Intent to Treat (ITT) population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).'}, {'type': 'PRIMARY', 'title': 'Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '11.3'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '9.2'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.696', 'ciLowerLimit': '0.558', 'ciUpperLimit': '0.867', 'groupDescription': 'The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\\<80 vs. ≥80)', 'statisticalMethod': 'Stratified log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.\n\nOnly deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009'}, {'type': 'PRIMARY', 'title': 'Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '8.0'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '9.2'}]}]}], 'analyses': [{'pValue': '0.2648', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.171', 'ciLowerLimit': '0.887', 'ciUpperLimit': '1.544', 'groupDescription': 'The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\\<80 vs. ≥80)', 'statisticalMethod': 'Stratified log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.\n\nOnly deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009'}, {'type': 'SECONDARY', 'title': 'Overall Survival Time (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '599', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'categories': [{'measurements': [{'value': '19.9', 'groupId': 'OG000', 'lowerLimit': '18.5', 'upperLimit': '21.3'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '19.8'}]}]}], 'analyses': [{'pValue': '0.0419', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.878', 'ciLowerLimit': '0.774', 'ciUpperLimit': '0.995', 'groupDescription': 'The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\\<80 vs. ≥80)', 'statisticalMethod': 'Stratified log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009', 'description': 'Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (allocation to treatment groups as randomized and treated)'}, {'type': 'SECONDARY', 'title': 'Overall Survival Time (KRAS Wild-Type Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '21.2', 'upperLimit': '26.3'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '17.4', 'upperLimit': '21.7'}]}]}], 'analyses': [{'pValue': '0.0093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.796', 'ciLowerLimit': '0.670', 'ciUpperLimit': '0.946', 'groupDescription': 'The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\\<80 vs. ≥80)', 'statisticalMethod': 'Stratified log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009', 'description': 'Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009'}, {'type': 'SECONDARY', 'title': 'Overall Survival Time (KRAS Mutant Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': '17.9'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '14.9', 'upperLimit': '19.4'}]}]}], 'analyses': [{'pValue': '0.7549', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.035', 'ciLowerLimit': '0.834', 'ciUpperLimit': '1.284', 'groupDescription': 'The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\\<80 vs. ≥80)', 'statisticalMethod': 'Stratified log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009', 'description': 'Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009'}, {'type': 'SECONDARY', 'title': 'Best Overall Response Rate - Independent Review Committee (IRC) Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '599', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000', 'lowerLimit': '42.9', 'upperLimit': '51.0'}, {'value': '38.7', 'groupId': 'OG001', 'lowerLimit': '34.8', 'upperLimit': '42.8'}]}]}], 'analyses': [{'pValue': '0.0038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '1.12', 'ciUpperLimit': '1.77', 'groupDescription': 'The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\\<80 vs. ≥80)', 'statisticalMethod': 'Stratified cochran-mantel haenszel test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (allocation to treatment groups as randomized and treated)'}, {'type': 'SECONDARY', 'title': 'Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000', 'lowerLimit': '51.6', 'upperLimit': '62.8'}, {'value': '39.7', 'groupId': 'OG001', 'lowerLimit': '34.6', 'upperLimit': '45.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.069', 'ciLowerLimit': '1.515', 'ciUpperLimit': '2.826', 'groupDescription': 'The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\\<80 vs. ≥80)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).', 'unitOfMeasure': 'percentage participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009'}, {'type': 'SECONDARY', 'title': 'Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '25.2', 'upperLimit': '38.0'}, {'value': '36.1', 'groupId': 'OG001', 'lowerLimit': '29.1', 'upperLimit': '43.5'}]}]}], 'analyses': [{'pValue': '0.3475', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.822', 'ciLowerLimit': '0.544', 'ciUpperLimit': '1.242', 'groupDescription': 'The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\\<80 vs. ≥80)', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate - Independent Review Committee (IRC) Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '599', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000', 'lowerLimit': '81.1', 'upperLimit': '87.1'}, {'value': '85.5', 'groupId': 'OG001', 'lowerLimit': '82.4', 'upperLimit': '88.2'}]}]}], 'analyses': [{'pValue': '0.6004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.26', 'groupDescription': 'The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\\<80 vs. ≥80)', 'statisticalMethod': 'Stratified cochran-mantel haenszel test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (allocation to treatment groups as randomized and treated)'}, {'type': 'SECONDARY', 'title': 'Duration of Response - Independent Review Committee (IRC) Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '599', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '12.9'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '8.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from first assessment of complete response or partial response to disease progression, death or last tumor assessment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).\n\nPatients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (allocation to treatment groups as randomized and treated)'}, {'type': 'SECONDARY', 'title': 'Participants With No Residual Tumor After Metastatic Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}, {'value': '599', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.02', 'ciLowerLimit': '1.45', 'ciUpperLimit': '6.27', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007', 'description': 'Participants with no residual tumor after on-study surgery for metastases', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (allocation to treatment groups as randomized and treated)'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'title': 'At baseline', 'categories': [{'measurements': [{'value': '58.88', 'spread': '1.185', 'groupId': 'OG000'}, {'value': '60.33', 'spread': '1.155', 'groupId': 'OG001'}]}]}, {'title': 'At week 8', 'categories': [{'measurements': [{'value': '59.02', 'spread': '1.187', 'groupId': 'OG000'}, {'value': '61.83', 'spread': '1.176', 'groupId': 'OG001'}]}]}, {'title': 'At week 16', 'categories': [{'measurements': [{'value': '60.77', 'spread': '1.276', 'groupId': 'OG000'}, {'value': '63.29', 'spread': '1.249', 'groupId': 'OG001'}]}]}, {'title': 'At week 24', 'categories': [{'measurements': [{'value': '61.83', 'spread': '1.368', 'groupId': 'OG000'}, {'value': '64.06', 'spread': '1.364', 'groupId': 'OG001'}]}]}, {'title': 'At week 32', 'categories': [{'measurements': [{'value': '59.68', 'spread': '1.590', 'groupId': 'OG000'}, {'value': '65.07', 'spread': '1.612', 'groupId': 'OG001'}]}]}, {'title': 'At week 40', 'categories': [{'measurements': [{'value': '63.43', 'spread': '1.835', 'groupId': 'OG000'}, {'value': '64.02', 'spread': '1.991', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '1125 subjects (566 Cetuximab + FOLFIRI; 559 FOLFIRI alone) completed at least 1 evaluable questionnaire \\& were included in the Evaluable for QLQ-C30 population. Numbers at each timepoint were (Cetuximab + FOLFORI/FOLFORI alone, respectively): baseline 430/423; Week 8 421/390; Week 16 312/309; Week 24 255/244; Week 32 164/154; Week 40 122/96'}, {'type': 'SECONDARY', 'title': 'Quality of Life Assessment (EORTC QLQ-C30) Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'title': 'At baseline', 'categories': [{'measurements': [{'value': '75.21', 'spread': '1.426', 'groupId': 'OG000'}, {'value': '77.28', 'spread': '1.395', 'groupId': 'OG001'}]}]}, {'title': 'At week 8', 'categories': [{'measurements': [{'value': '74.14', 'spread': '1.430', 'groupId': 'OG000'}, {'value': '76.71', 'spread': '1.415', 'groupId': 'OG001'}]}]}, {'title': 'At week 16', 'categories': [{'measurements': [{'value': '73.72', 'spread': '1.533', 'groupId': 'OG000'}, {'value': '76.67', 'spread': '1.498', 'groupId': 'OG001'}]}]}, {'title': 'At week 24', 'categories': [{'measurements': [{'value': '76.31', 'spread': '1.644', 'groupId': 'OG000'}, {'value': '77.98', 'spread': '1.633', 'groupId': 'OG001'}]}]}, {'title': 'At week 32', 'categories': [{'measurements': [{'value': '74.04', 'spread': '1.903', 'groupId': 'OG000'}, {'value': '75.64', 'spread': '1.933', 'groupId': 'OG001'}]}]}, {'title': 'At week 40', 'categories': [{'measurements': [{'value': '76.58', 'spread': '2.198', 'groupId': 'OG000'}, {'value': '78.07', 'spread': '2.388', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '1125 subjects (566 in the Cetuximab + FOLFIRI arm and 559 in the FOLFIRI alone arm) completed at least one evaluable QLQ-C30 questionnaire and were thus included in the Evaluable for QLQ-C30 population'}, {'type': 'SECONDARY', 'title': 'Safety - Number of Patients Experiencing Any Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '600', 'groupId': 'OG000'}, {'value': '602', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'OG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'classes': [{'categories': [{'measurements': [{'value': '599', 'groupId': 'OG000'}, {'value': '597', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007', 'description': 'Please refer to Adverse Events section for further details', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'FG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized and treated subjects; 1 additional subject was treated but not randomised', 'groupId': 'FG000', 'numSubjects': '599'}, {'comment': 'Randomized and treated subjects; 3 additional subjects were treated but not randomised', 'groupId': 'FG001', 'numSubjects': '599'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '592'}, {'groupId': 'FG001', 'numSubjects': '597'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'investigational study phase ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'First/Last subject in: 10 Aug 2004/4 Nov 2005. Clinical cut-off efficacy analyses except survival: 27 Jul 2006, Cut off date IRC data: 14 Dec 2006; cut-off safety analyses: 30 Nov 2007; cut-off survival analyses: 31 May 2009; cut-off KRAS analyses: 28 Aug 2009.\n\n1221 subjects were randomised or treated, of whom 1198 were randomised and treated.', 'preAssignmentDetails': 'At the prescreening visit the subject completed the first informed consent form, and a sample of tumor tissue for determination of EGFR expression was to be obtained.\n\nThe screening (baseline) visit was performed no more than 21 days before randomization. EGFR-expressing subjects completed a second informed consent form to participate in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'BG000'}, {'value': '599', 'groupId': 'BG001'}, {'value': '1198', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cetuximab Plus FOLFIRI', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'BG001', 'title': 'FOLFIRI Alone', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'spread': '10.52', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '11.06', 'groupId': 'BG001'}, {'value': '59.9', 'spread': '10.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age missing for 1 subject', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '374', 'groupId': 'BG000'}, {'value': '377', 'groupId': 'BG001'}, {'value': '751', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '446', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Age missing for 1 subject', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '473', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '369', 'groupId': 'BG000'}, {'value': '356', 'groupId': 'BG001'}, {'value': '725', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Western Europe', 'categories': [{'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '529', 'groupId': 'BG002'}]}]}, {'title': 'Eastern Europe', 'categories': [{'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}]}, {'title': 'Rest of the World', 'categories': [{'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-12', 'studyFirstSubmitDate': '2005-09-08', 'resultsFirstSubmitDate': '2010-11-30', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-27', 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments', 'timeFrame': 'Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.\n\nOnly deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.'}, {'measure': 'Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments', 'timeFrame': 'Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.\n\nOnly deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.'}, {'measure': 'Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments', 'timeFrame': 'Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.\n\nOnly deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival Time (OS)', 'timeFrame': 'Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009', 'description': 'Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.'}, {'measure': 'Overall Survival Time (KRAS Wild-Type Population)', 'timeFrame': 'Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009', 'description': 'Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.'}, {'measure': 'Overall Survival Time (KRAS Mutant Population)', 'timeFrame': 'Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009', 'description': 'Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.'}, {'measure': 'Best Overall Response Rate - Independent Review Committee (IRC) Assessments', 'timeFrame': 'evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).'}, {'measure': 'Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments', 'timeFrame': 'evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).'}, {'measure': 'Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments', 'timeFrame': 'evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).'}, {'measure': 'Disease Control Rate - Independent Review Committee (IRC) Assessments', 'timeFrame': 'Evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).'}, {'measure': 'Duration of Response - Independent Review Committee (IRC) Assessments', 'timeFrame': 'Time from first assessment of complete response or partial response to disease progression, death or last tumor assessment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).\n\nPatients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.'}, {'measure': 'Participants With No Residual Tumor After Metastatic Surgery', 'timeFrame': 'time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007', 'description': 'Participants with no residual tumor after on-study surgery for metastases'}, {'measure': 'Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status', 'timeFrame': 'at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.'}, {'measure': 'Quality of Life Assessment (EORTC QLQ-C30) Social Functioning', 'timeFrame': 'at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006', 'description': 'Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.'}, {'measure': 'Safety - Number of Patients Experiencing Any Adverse Event', 'timeFrame': 'time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007', 'description': 'Please refer to Adverse Events section for further details'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Metastatic colorectal cancer', 'EGFR', 'Irinotecan', 'cetuximab', 'first-line treatment'], 'conditions': ['Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '19339720', 'type': 'RESULT', 'citation': "Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019."}, {'type': 'RESULT', 'citation': 'Van Cutsem E, Lang I, Folprecht G, Nowacki M, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Celik I, Kohne C Cetuximab plus FOLFIRI in the treatment of metastatic colorectal cancer (mCRC): The influence of KRAS and BRAF biomarkers on outcome: Updated data from the CRYSTAL trial. ASCO 2010 Gastrointestinal Cancers Symposium, Orlando, USA January 2010 Abstract No: 281'}, {'type': 'RESULT', 'citation': 'Lang I, Kohne CH, Folprecht G, Nowacki MP, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Zubel A, Van Cutsem E Cetuximab plus FOLFIRI in 1st-line treatment of metastatic colorectal cancer: Quality of life (QoL) analysis of patients (pts) with KRAS wild-type (wt) tumours in the CRYSTAL trial. European Journal of Cancer Supplements. 2009 7(2):345'}, {'pmid': '30657405', 'type': 'DERIVED', 'citation': 'Dercle L, Lu L, Lichtenstein P, Yang H, Wang D, Zhu J, Wu F, Piessevaux H, Schwartz LH, Zhao B. Impact of Variability in Portal Venous Phase Acquisition Timing in Tumor Density Measurement and Treatment Response Assessment: Metastatic Colorectal Cancer as a Paradigm. JCO Clin Cancer Inform. 2017 Nov;1:1-8. doi: 10.1200/CCI.17.00108.'}, {'pmid': '27722750', 'type': 'DERIVED', 'citation': 'Tejpar S, Stintzing S, Ciardiello F, Tabernero J, Van Cutsem E, Beier F, Esser R, Lenz HJ, Heinemann V. Prognostic and Predictive Relevance of Primary Tumor Location in Patients With RAS Wild-Type Metastatic Colorectal Cancer: Retrospective Analyses of the CRYSTAL and FIRE-3 Trials. JAMA Oncol. 2017 Feb 1;3(2):194-201. doi: 10.1001/jamaoncol.2016.3797.'}, {'pmid': '23265711', 'type': 'DERIVED', 'citation': 'Licitra L, Storkel S, Kerr KM, Van Cutsem E, Pirker R, Hirsch FR, Vermorken JB, von Heydebreck A, Esser R, Celik I, Ciardiello F. Predictive value of epidermal growth factor receptor expression for first-line chemotherapy plus cetuximab in patients with head and neck and colorectal cancer: analysis of data from the EXTREME and CRYSTAL studies. Eur J Cancer. 2013 Apr;49(6):1161-8. doi: 10.1016/j.ejca.2012.11.018. Epub 2012 Dec 19.'}]}, 'descriptionModule': {'briefSummary': "Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Giving combination chemotherapy together with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer ('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with cetuximab is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil (5FU)/Folinic acid (FA) plus irinotecan) for metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone on patient expressing the epidermal growth factor (EGF) receptor.\n\nPatients expressing this EGF Receptor will be randomly assign in one of the 2 groups to either receive the combination chemotherapy alone or with cetuximab (open-label study) and will then be treated until progression of the disease or unacceptable toxicity occur. Regular efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study together with regular safety assessments (e.g. safety labs). An independent Safety Board of experts will also monitor safety data.\n\nAfter participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator.\n\nThe entire study (from the first patient entering the study to the last collect of follow-up information) is 4-5 years long."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum\n* Inoperable metastatic disease\n* Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue\n* Presence of at least 1 bi-dimensionally measurable index lesion\n\nExclusion Criteria:\n\n* Previous irinotecan-based chemotherapy\n* Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment\n* Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of study treatment\n* Brain metastasis'}, 'identificationModule': {'nctId': 'NCT00154102', 'acronym': 'CRYSTAL', 'briefTitle': 'Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Open, Randomized, Controlled, Multicenter Phase III Study Comparing 5FU/ FA Plus Irinotecan Plus Cetuximab Versus 5FU/FA Plus Irinotecan as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'EMR 62202-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cetuximab Plus FOLFIRI', 'interventionNames': ['Drug: Cetuximab', 'Drug: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FOLFIRI Alone', 'interventionNames': ['Drug: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)']}], 'interventions': [{'name': 'Cetuximab', 'type': 'DRUG', 'description': 'Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Number of Cycles: until progression or unacceptable toxicity develops', 'armGroupLabels': ['Cetuximab Plus FOLFIRI']}, {'name': 'FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)', 'type': 'DRUG', 'description': 'Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops', 'armGroupLabels': ['Cetuximab Plus FOLFIRI', 'FOLFIRI Alone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Bedford Park', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'city': 'Darlinghurst', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, 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