Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-03 @ 8:37 PM
Study NCT ID:
NCT00678535
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2008-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer
Sponsor:
Organization:
Raw JSON
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'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': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@merck.de', 'phone': '+49-6151-72-5200', 'title': 'Merck KGaA Communication Center', 'organization': 'Merck Serono, a division of Merck KGaA'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Time from first dose up to 30 days after the last dose of study treatment.', 'description': 'An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.', 'eventGroups': [{'id': 'EG000', 'title': 'Cetuximab Plus Capecitabine Plus Cisplatin', 'description': 'Cetuximab weekly (initial dose 400 milligram per square meter \\[mg/m\\^2\\] followed by 250 mg/m\\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.', 'otherNumAtRisk': 446, 'otherNumAffected': 441, 'seriousNumAtRisk': 446, 'seriousNumAffected': 239}, {'id': 'EG001', 'title': 'Capecitabine Plus Cisplatin', 'description': 'Cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.', 'otherNumAtRisk': 436, 'otherNumAffected': 429, 'seriousNumAtRisk': 436, 'seriousNumAffected': 194}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 194}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 234}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 155}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 89}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 94}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 23}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 273}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 265}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 172}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 105}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 165}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 192}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 110}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 72}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 187}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 162}], 'organSystem': 'General disorders'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 98}], 'organSystem': 'General disorders'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 31}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 38}], 'organSystem': 'General disorders'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 26}], 'organSystem': 'General disorders'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 11}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 77}], 'organSystem': 'Investigations'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 37}], 'organSystem': 'Investigations'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 35}], 'organSystem': 'Investigations'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 37}], 'organSystem': 'Investigations'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 13}], 'organSystem': 'Investigations'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 16}], 'organSystem': 'Investigations'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 22}], 'organSystem': 'Investigations'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 22}], 'organSystem': 'Investigations'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 221}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 201}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 60}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 56}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 38}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 34}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 45}], 'organSystem': 'Nervous system disorders'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 27}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 29}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 22}], 'organSystem': 'Nervous system disorders'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 41}], 'organSystem': 'Nervous system disorders'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 27}], 'organSystem': 'Nervous system disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 32}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 47}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 194}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 162}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 97}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 4}], 'organSystem': 'Cardiac disorders'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 3}], 'organSystem': 'Cardiac disorders'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Pyloric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders'}, {'term': 'Auricular perichondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Endocrine disorders'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Endocrine disorders'}, {'term': 'Ocular icterus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 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'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Soft tissue necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Spondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Metastases to ovary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and 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'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 5}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Facial paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 2}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 2}], 'organSystem': 'Vascular disorders'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 2}], 'organSystem': 'Vascular disorders'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 446, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 436, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '449', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus Capecitabine Plus Cisplatin', 'description': 'Cetuximab weekly (initial dose 400 milligram per square meter \\[mg/m\\^2\\] followed by 250 mg/m\\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}, {'id': 'OG001', 'title': 'Capecitabine Plus Cisplatin', 'description': 'Cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '5.5'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '5.7'}]}]}], 'analyses': [{'pValue': '0.3158', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.091', 'ciLowerLimit': '0.920', 'ciUpperLimit': '1.292', 'estimateComment': 'Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.', 'groupDescription': 'Primary efficacy analysis: To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo-) adjuvant(radio) chemotherapy, α=5%).', 'statisticalMethod': 'Stratified log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)', 'description': 'The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants 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 included all participants who were randomized to trial treatment.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '449', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus Capecitabine Plus Cisplatin', 'description': 'Cetuximab weekly (initial dose 400 milligram per square meter \\[mg/m\\^2\\] followed by 250 mg/m\\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}, {'id': 'OG001', 'title': 'Capecitabine Plus Cisplatin', 'description': 'Cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '10.6'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '11.3'}]}]}], 'analyses': [{'pValue': '0.9547', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.004', 'ciLowerLimit': '0.866', 'ciUpperLimit': '1.165', 'estimateComment': 'Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.', 'groupDescription': 'To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior (neo-) adjuvant(radio) chemotherapy, α=5%)', 'statisticalMethod': 'Stratified log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)', 'description': 'The OS time is defined as the time from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to trial treatment.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '449', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus Capecitabine Plus Cisplatin', 'description': 'Cetuximab weekly (initial dose 400 milligram per square meter \\[mg/m\\^2\\] followed by 250 mg/m\\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}, {'id': 'OG001', 'title': 'Capecitabine Plus Cisplatin', 'description': 'Cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000', 'lowerLimit': '25.7', 'upperLimit': '34.3'}, {'value': '29.2', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': '33.6'}]}]}], 'analyses': [{'pValue': '0.7696', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.0435', 'ciLowerLimit': '0.7844', 'ciUpperLimit': '1.3882', 'groupDescription': 'The best overall response rate was compared with the Cochran-Mantel-Haenszel test (strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo-) adjuvant(radio) chemotherapy, two-sided with α=5%).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)', 'description': 'The BOR rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors \\[RECIST\\] Version 1.0) from the IRC.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who were randomized to trial treatment.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus Capecitabine Plus Cisplatin', 'description': 'Cetuximab weekly (initial dose 400 milligram per square meter \\[mg/m\\^2\\] followed by 250 mg/m\\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}, {'id': 'OG001', 'title': 'Capecitabine Plus Cisplatin', 'description': 'Cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}], 'classes': [{'title': 'Global health status: Baseline', 'categories': [{'measurements': [{'value': '57.49', 'spread': '22.168', 'groupId': 'OG000'}, {'value': '57.19', 'spread': '22.124', 'groupId': 'OG001'}]}]}, {'title': 'Global health status: Week 6', 'categories': [{'measurements': [{'value': '59.00', 'spread': '21.879', 'groupId': 'OG000'}, {'value': '61.80', 'spread': '22.089', 'groupId': 'OG001'}]}]}, {'title': 'Global health status: Week 12', 'categories': [{'measurements': [{'value': '60.17', 'spread': '20.796', 'groupId': 'OG000'}, {'value': '63.35', 'spread': '22.077', 'groupId': 'OG001'}]}]}, {'title': 'Global health status: Week 18', 'categories': [{'measurements': [{'value': '60.45', 'spread': '20.015', 'groupId': 'OG000'}, {'value': '61.83', 'spread': '21.499', 'groupId': 'OG001'}]}]}, {'title': 'Global health status: Week 24', 'categories': [{'measurements': [{'value': '62.46', 'spread': '22.978', 'groupId': 'OG000'}, {'value': '63.61', 'spread': '19.477', 'groupId': 'OG001'}]}]}, {'title': 'Global health status: Week 30', 'categories': [{'measurements': [{'value': '63.65', 'spread': '21.722', 'groupId': 'OG000'}, {'value': '64.11', 'spread': '19.757', 'groupId': 'OG001'}]}]}, {'title': 'Global health status: Week 36', 'categories': [{'measurements': [{'value': '65.06', 'spread': '22.629', 'groupId': 'OG000'}, {'value': '57.72', 'spread': '21.602', 'groupId': 'OG001'}]}]}, {'title': 'Global health status: Week 42', 'categories': [{'measurements': [{'value': '59.29', 'spread': '21.558', 'groupId': 'OG000'}, {'value': '62.64', 'spread': '22.005', 'groupId': 'OG001'}]}]}, {'title': 'Global health status: Week 48', 'categories': [{'measurements': [{'value': '63.39', 'spread': '21.317', 'groupId': 'OG000'}, {'value': '66.67', 'spread': '19.395', 'groupId': 'OG001'}]}]}, {'title': 'Global health status: Week 54', 'categories': [{'measurements': [{'value': '60.63', 'spread': '16.198', 'groupId': 'OG000'}, {'value': '66.67', 'spread': '14.651', 'groupId': 'OG001'}]}]}, {'title': 'Global health status: Week 60', 'categories': [{'measurements': [{'value': '62.50', 'spread': '13.918', 'groupId': 'OG000'}, {'value': '61.81', 'spread': '17.210', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning status: Baseline', 'categories': [{'measurements': [{'value': '74.36', 'spread': '27.077', 'groupId': 'OG000'}, {'value': '76.52', 'spread': '26.601', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning status: Week 6', 'categories': [{'measurements': [{'value': '68.94', 'spread': '28.885', 'groupId': 'OG000'}, {'value': '75.70', 'spread': '27.415', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning status: Week 12', 'categories': [{'measurements': [{'value': '71.48', 'spread': '26.547', 'groupId': 'OG000'}, {'value': '75.65', 'spread': '27.691', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning status: Week 18', 'categories': [{'measurements': [{'value': '71.22', 'spread': '25.317', 'groupId': 'OG000'}, {'value': '75.51', 'spread': '25.612', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning status: Week 24', 'categories': [{'measurements': [{'value': '74.20', 'spread': '26.143', 'groupId': 'OG000'}, {'value': '78.26', 'spread': '27.633', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning status: Week 30', 'categories': [{'measurements': [{'value': '78.51', 'spread': '24.766', 'groupId': 'OG000'}, {'value': '76.67', 'spread': '24.962', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning status: Week 36', 'categories': [{'measurements': [{'value': '76.28', 'spread': '21.730', 'groupId': 'OG000'}, {'value': '73.58', 'spread': '22.353', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning status: Week 42', 'categories': [{'measurements': [{'value': '68.57', 'spread': '27.348', 'groupId': 'OG000'}, {'value': '78.16', 'spread': '22.318', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning status at Week 48', 'categories': [{'measurements': [{'value': '80.36', 'spread': '22.705', 'groupId': 'OG000'}, {'value': '78.00', 'spread': '23.432', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning status: Week 54', 'categories': [{'measurements': [{'value': '74.71', 'spread': '27.682', 'groupId': 'OG000'}, {'value': '80.56', 'spread': '27.371', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning status: Week 60', 'categories': [{'measurements': [{'value': '78.33', 'spread': '23.632', 'groupId': 'OG000'}, {'value': '68.06', 'spread': '32.144', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)', 'description': 'Mean global health status and 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 better QoL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants who had at least one evaluable EORTC QLQ-C30 questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus Capecitabine Plus Cisplatin', 'description': 'Cetuximab weekly (initial dose 400 milligram per square meter \\[mg/m\\^2\\] followed by 250 mg/m\\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}, {'id': 'OG001', 'title': 'Capecitabine Plus Cisplatin', 'description': 'Cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.743', 'spread': '0.240', 'groupId': 'OG000'}, {'value': '0.749', 'spread': '0.235', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '0.739', 'spread': '0.276', 'groupId': 'OG000'}, {'value': '0.769', 'spread': '0.254', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.752', 'spread': '0.239', 'groupId': 'OG000'}, {'value': '0.775', 'spread': '0.246', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '0.742', 'spread': '0.251', 'groupId': 'OG000'}, {'value': '0.755', 'spread': '0.235', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.733', 'spread': '0.300', 'groupId': 'OG000'}, {'value': '0.761', 'spread': '0.265', 'groupId': 'OG001'}]}]}, {'title': 'Week 30', 'categories': [{'measurements': [{'value': '0.737', 'spread': '0.301', 'groupId': 'OG000'}, {'value': '0.790', 'spread': '0.230', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '0.710', 'spread': '0.311', 'groupId': 'OG000'}, {'value': '0.711', 'spread': '0.309', 'groupId': 'OG001'}]}]}, {'title': 'Week 42', 'categories': [{'measurements': [{'value': '0.722', 'spread': '0.209', 'groupId': 'OG000'}, {'value': '0.689', 'spread': '0.307', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.719', 'spread': '0.227', 'groupId': 'OG000'}, {'value': '0.770', 'spread': '0.216', 'groupId': 'OG001'}]}]}, {'title': 'Week 54', 'categories': [{'measurements': [{'value': '0.733', 'spread': '0.275', 'groupId': 'OG000'}, {'value': '0.730', 'spread': '0.191', 'groupId': 'OG001'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '0.760', 'spread': '0.322', 'groupId': 'OG000'}, {'value': '0.742', 'spread': '0.170', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)', 'description': "EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 single items are combined to obtain a single index score that is health utility index (HUI) score reflecting subject's preferences for different health states. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QoL.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants who had at least one evaluable EuroQoL EQ-5D questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Safety - Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab Plus Capecitabine Plus Cisplatin', 'description': 'Cetuximab weekly (initial dose 400 milligram per square meter \\[mg/m\\^2\\] followed by 250 mg/m\\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}, {'id': 'OG001', 'title': 'Capecitabine Plus Cisplatin', 'description': 'Cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}], 'classes': [{'categories': [{'measurements': [{'value': '446', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of any trial treatment that is, cetuximab, cisplatin, or capecitabine.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cetuximab Plus Capecitabine Plus Cisplatin', 'description': 'Cetuximab weekly (initial dose 400 milligram per square meter \\[mg/m\\^2\\] followed by 250 mg/m\\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}, {'id': 'FG001', 'title': 'Capecitabine Plus Cisplatin', 'description': 'Cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'ITT population', 'groupId': 'FG000', 'numSubjects': '455'}, {'comment': 'ITT population', 'groupId': 'FG001', 'numSubjects': '449'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'subjects who died before or at 31 March 2012', 'groupId': 'FG000', 'numSubjects': '362'}, {'comment': 'subjects who died before or at 31 March 2012', 'groupId': 'FG001', 'numSubjects': '351'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '98'}]}]}], 'recruitmentDetails': 'First/last participant (informed consent): June 2008/December 2010. Clinical data cut-off: 31 March 2012 Study completion 17 February 2013.', 'preAssignmentDetails': 'Enrolled: 1,191 screened for eligibility; 287 excluded (mainly non-fulfillment of inclusion or exclusion criteria). 904 participants randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'BG000'}, {'value': '449', 'groupId': 'BG001'}, {'value': '904', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cetuximab Plus Capecitabine Plus Cisplatin', 'description': 'Cetuximab weekly (initial dose 400 milligram per square meter \\[mg/m\\^2\\] followed by 250 mg/m\\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}, {'id': 'BG001', 'title': 'Capecitabine Plus Cisplatin', 'description': 'Cisplatin (3-week cycle, 80 mg/m\\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'spread': '11.16', 'groupId': 'BG000'}, {'value': '58.5', 'spread': '10.83', 'groupId': 'BG001'}, {'value': '58.3', 'spread': '11.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '339', 'groupId': 'BG000'}, {'value': '334', 'groupId': 'BG001'}, {'value': '673', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 904}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-11', 'studyFirstSubmitDate': '2008-05-13', 'resultsFirstSubmitDate': '2013-03-30', 'studyFirstSubmitQcDate': '2008-05-14', 'lastUpdatePostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-30', 'studyFirstPostDateStruct': {'date': '2008-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments', 'timeFrame': 'Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)', 'description': 'The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)', 'description': 'The OS time is defined as the time from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.'}, {'measure': 'Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments', 'timeFrame': 'Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)', 'description': 'The BOR rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors \\[RECIST\\] Version 1.0) from the IRC.'}, {'measure': 'Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)', 'timeFrame': 'Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)', 'description': 'Mean global health status and 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 better QoL.'}, {'measure': 'Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire', 'timeFrame': 'Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)', 'description': "EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 single items are combined to obtain a single index score that is health utility index (HUI) score reflecting subject's preferences for different health states. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QoL."}, {'measure': 'Safety - Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['1st line treatment for Gastric Cancer', 'Cetuximab', 'Capecitabine', 'Xeloda', 'Cisplatin', 'Progression-free survival'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) \\[XP\\] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS).\n\nSecondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent before any study-related activities are carried out\n* Age greater than or equal to (\\>=) 18 years\n* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Adenocarcinoma of the gastroesophageal junction \\[AEG\\] Types I-III according to Siewert classification)\n* Archived tumor material sample for at least subsequent standardized Epidermal Growth Factor Receptor (EGFR) expression assessment\n* Unresectable advanced (M0) or unresectable metastatic (M1) disease\n* At least one radiographically documented measurable lesion in a previously non-irradiated area according to response evaluation criteria in solid tumors (RECIST). The primary tumor site is to be considered as a non-measurable lesion only\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Estimated life expectancy greater than (\\>) 12 weeks\n* Medically accepted contraception (if the risk of conception exists)\n* Glomerular filtration rate (GFR) \\>= 60 milliliter per minute (mL/min) The GFR is based on the Cockcroft-Gault formula for creatinine clearance\n* Aspartate-aminotransferase (ASAT) less than or equal to (=\\<) 2.5 \\* upper limit of normal (ULN) and alanine-aminotransferase (ALAT) =\\< 2.5 \\*ULN\n* Bilirubin =\\< 3 \\* ULN\n* Absolute neutrophil count (ANC) \\>= 1.5 \\* 10\\^9 per liter\n* Platelets \\>= 100 \\* 10\\^9 per liter\n* Hemoglobin \\>=10 gram per deciliter (g/dL) (without transfusions)\n* Sodium and potassium within normal limits or =\\< 10 percent above or below (supplementation permitted)\n\nExclusion Criteria:\n\n* Prior chemotherapy, however, previous (neo-)adjuvant (radio-) chemotherapy allowed if finished \\> 1 year prior to start of study treatment and no more than 300 mg/m\\^2 cisplatin has been administered\n* Prior treatment with an antibody or molecule targeting EGFR and/or Vascular Endothelial Growth Factor Receptor (VEGFR) related signaling pathways\n* Brain metastasis and/or leptomeningeal disease (known or suspected)\n* Radiotherapy (except localized radiotherapy for pain relief), major surgery or any investigational drug within 30 days before the start of study treatment\n* Concurrent chronic systemic immune or hormone therapy not indicated in this study protocol (except for physiologic replacement)\n* Clinically relevant coronary artery disease (New York Heart Association \\[NYHA\\] functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the 12 months before study Screening, or high risk of uncontrolled arrhythmia\n* Active Hepatitis B or C\n* Chronic diarrhea or short bowel syndrome\n* Presence of any contra-indication to treatment with cetuximab, capecitabine and cisplatin including:\n\n * Known hypersensitivity to capecitabine, fluorouracil, cisplatin, cetuximab or to any of the excipients of these drugs\n * Known dihydropyrimidine dehydrogenase (DPD) deficiency\n * Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption\n * Current treatment with sorivudine or chemically related analogues, such as brivudine\n * Symptomatic peripheral neuropathy National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade \\>= 2 and/or ototoxicity NCI CTCAE Grade \\>= 2, except if due to trauma or mechanical impairment due to tumor mass\n* Pregnancy or lactation period\n* Concurrent treatment with a non-permitted drug\n* Treatment in another clinical study within 30 days prior to study screening\n* Previous malignancy other than gastric cancer within 5 years prior to study screening, except for basal cell cancer of the skin or pre-invasive cancer of the cervix\n* Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent\n* Legal incapacity or limited legal capacity\n* Significant disease which, in the Investigator's opinion, would exclude the subject from the study"}, 'identificationModule': {'nctId': 'NCT00678535', 'acronym': 'EXPAND', 'briefTitle': 'Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Open-label, Randomized, Controlled, Multicenter Phase III Study Investigating Cetuximab in Combination With Capecitabine (Xeloda, X) and Cisplatin (P) Versus XP Alone as First-line Treatment for Subjects With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction', 'orgStudyIdInfo': {'id': 'EMR 200048-052'}, 'secondaryIdInfos': [{'id': '2007-004219-75', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cetuximab plus Capecitabine plus Cisplatin', 'interventionNames': ['Drug: Cetuximab', 'Drug: Capecitabine', 'Drug: Cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Capecitabine plus Cisplatin', 'interventionNames': ['Drug: Capecitabine', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Cetuximab', 'type': 'DRUG', 'otherNames': ['Erbitux'], 'description': 'Single first dose of cetuximab 400 milligram per square meter (mg/m\\^2) will be administered intravenously over 120 minutes followed by weekly intravenous infusion of cetuximab 250 mg/m\\^2 over 60 minutes in each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.', 'armGroupLabels': ['Cetuximab plus Capecitabine plus Cisplatin']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Capecitabine 1000 mg/m\\^2 will be administered orally twice daily from evening of Day 1 to morning of Day 15 for every 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.', 'armGroupLabels': ['Capecitabine plus Cisplatin', 'Cetuximab plus Capecitabine plus Cisplatin']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin 80 mg/m\\^2 will be administered intravenously with infusion over 1 to 4 hours on Day 1 of each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.', 'armGroupLabels': ['Capecitabine plus Cisplatin', 'Cetuximab plus Capecitabine plus Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rosario', 'country': 'Argentina', 'facility': 'Research site', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'city': 'Coburg VIC', 'country': 'Australia', 'facility': 'Research site'}, {'city': 'Frankston, VIC', 'country': 'Australia', 'facility': 'Research site', 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