Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-07 @ 1:02 AM
Study NCT ID:
NCT00112294
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2005-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C080625', 'term': 'taxane'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The AEs represented here do not include SAEs. As such, these numbers may not match with the AEs presented as an Outcome Measure.', 'eventGroups': [{'id': 'EG000', 'title': 'Cetuximab+Taxane+Carboplatin', 'otherNumAtRisk': 325, 'otherNumAffected': 322, 'seriousNumAtRisk': 325, 'seriousNumAffected': 183}, {'id': 'EG001', 'title': 'Taxane+Carboplatin', 'otherNumAtRisk': 320, 'otherNumAffected': 317, 'seriousNumAtRisk': 320, 'seriousNumAffected': 121}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 141}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 131}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 97}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 32}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 51}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 41}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 99}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 81}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 46}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 28}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 105}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 47}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 46}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 104}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Exfoliative rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 243}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 228}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 8}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 19}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 69}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 36}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 198}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 161}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 64}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 34}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 186}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 47}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 93}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neck 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'numAtRisk': 320, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neutropenic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 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'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pericardial effusion malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 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'numAtRisk': 320, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Syncope vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vertigo labyrinthine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting projectile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 320, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Number of Months of Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.40', 'groupId': 'OG000', 'lowerLimit': '4.11', 'upperLimit': '5.06'}, {'value': '4.24', 'groupId': 'OG001', 'lowerLimit': '3.94', 'upperLimit': '4.63'}]}]}], 'analyses': [{'pValue': '0.2358', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.902', 'ciLowerLimit': '0.761', 'ciUpperLimit': '1.069', 'pValueComment': 'Since only 1 primary comparison was conducted, no adjustment for multiple comparisons was needed.', 'estimateComment': "The hazard ratio of C/T/C to T/C was estimated by means of a stratified Cox's proportional hazard model, with treatment as the single covariate.", 'groupDescription': 'Confidence intervals calculated using Brookmeyer and Crowley method. Primary analysis was comparison of PFS between arms performed by 2-sided alpha=0.05 level, log-rank test, stratified by ECOG PS (0/1) and intended on-study taxane (docetaxel or paclitaxel). Null hypothesis was that PFS was equal in both groups. Power calculations indicated that \\>=510 events (IRRC progressions/deaths) would lead to \\>=90% power at the 5% level for rejecting the null hypothesis, given a true hazard ratio of 0.75.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months).', 'description': 'Interval between randomization date \\& earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): \\>=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments \\& were still alive, date of randomization used.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (intention to treat population).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complete Response (CR) or Partial Response (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0066', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.675', 'ciLowerLimit': '1.152', 'ciUpperLimit': '2.436', 'estimateComment': 'The odds ratio is presented for C/T/C to T/C.', 'groupDescription': 'The 2 groups were compared by means of a Cochran-Mantel-Haenszel (CMH) (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to end of study drug therapy (up to 174 weeks).', 'description': 'Tumor response was defined as the number of participants whose best response was CR or PR, per the IRRC assessment, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR: \\>= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (intention to treat population).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '230', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1501', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.265', 'ciLowerLimit': '0.918', 'ciUpperLimit': '1.741', 'estimateComment': 'The odds ratio is presented for C/T/C to T/C.', 'groupDescription': 'The 2 groups were compared by means of a CMH (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to end of study drug therapy (up to 174 weeks).', 'description': 'Disease control was defined as the number of participants whose best response was CR, PR, or SD, per the IRRC assessment, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR:\\>= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression (to qualify as CR or PR, no new lesions could be present); SD: participants who did not meet the criteria for CR, PR, or PD (PD:\\>=25% increase in SOPD of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (intention to treat population).'}, {'type': 'SECONDARY', 'title': 'Median Number of Months of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.55', 'groupId': 'OG000', 'lowerLimit': '4.40', 'upperLimit': '6.83'}, {'value': '4.90', 'groupId': 'OG001', 'lowerLimit': '4.24', 'upperLimit': '5.72'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from first occurrence of CR or PR (whichever was recorded first) to the date of PD, death or date of last tumor assessment (up to 19 months).', 'description': 'Median number of months of response (time from first occurrence of CR/PR to date of PD/death, \\[per IRRC assessment,using modified WHO criteria\\]) calculated for participants whose best response=CR/PR.For participants who did not progress/die, date of last tumor assessment used.CR:disappearance of all index/non-index lesions;PR:\\>= 50% reduction in SOPD of index lesions compared with baseline, no evidence of progression.No new lesions present.PD:\\>=25% increase in SOPD of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a best response of CR or PR.'}, {'type': 'SECONDARY', 'title': 'Median Number of Months to Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '12.65'}, {'value': '1.35', 'groupId': 'OG001', 'lowerLimit': '0.99', 'upperLimit': '4.83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from first dose of study therapy to the date of PR or CR, whichever occurred first (up to 13 months).', 'description': 'The median number of months to response was calculated for participants whose best response was CR or PR. It was defined as the time from the first dose of study therapy to the first date that criteria for PR or CR (whichever occurred first)were met. Response was assessed by the IRRC, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR: \\>= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a best response of CR or PR.'}, {'type': 'SECONDARY', 'title': 'Median Number of Months of Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.69', 'groupId': 'OG000', 'lowerLimit': '8.28', 'upperLimit': '11.50'}, {'value': '8.38', 'groupId': 'OG001', 'lowerLimit': '7.33', 'upperLimit': '9.92'}]}]}], 'analyses': [{'pValue': '0.1685', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.890', 'ciLowerLimit': '0.754', 'ciUpperLimit': '1.051', 'pValueComment': 'An interim analysis on survival was performed. Final p-value was adjusted using an alpha spending function. At the interim analysis (data not reported here) the type 1 error was 0.0001, and the rest is for the final look.', 'estimateComment': "The hazard ratio of C/T/C to T/C was estimated by means of a stratified Cox's proportional hazard model with treatment as the single covariate.", 'groupDescription': 'Confidence intervals were calculated using Brookmeyer and Crowley method. Analysis was a comparison of survival between groups by means of a 2-sided, alpha=0.05 level, log-rank test, stratified by ECOG PS (0/1) and intended on-study taxane (docetaxel or paclitaxel). Null hypothesis was that survival was equal in both treatment arms. Power calculations indicated that \\>= 558 events would lead to at \\>=75% power at the 5% level for rejecting the null hypothesis, given a true hazard ratio of 0.8.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to death or date of last contact (up to 41 months).', 'description': 'The median number of months of survival was defined as the time from randomization to the date of death. For participants who did not die, the date of last contact was used.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (intention to treat population).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improvement of Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Improvement of symptoms was compared between groups by means of a CMH (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).', 'description': 'Symptoms were assessed using the Functional Assessment of Cancer Therapy - Lung Cancer Subscale (FACT-LCS) questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic in all symptoms assessed) to 28 (symptom-free on all symptoms assessed). Symptom response (improvement) was defined as \\>= 2-point increase from baseline in score (maintained for 2 consecutive assessments, at least 3 weeks apart). Participants with a baseline score of \\>= 27 were not evaluable, as it would not have been possible to show an improvement. Participants with no baseline data were also not evaluable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who completed a baseline FACT-LCS questionnaire (ie, who completed a questionnaire \\<=14 days prior to treatment, or if they were never treated, \\<=14 days prior to randomization) and who had a baseline score of 26 or less.'}, {'type': 'SECONDARY', 'title': 'Median Number of Months Until Symptomatic Progression (Worsening of Symptoms)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'timeFrame': 'From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).', 'description': 'Symptoms were assessed using the FACT-LCS questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic) to 28 (symptom-free). Symptomatic progression was defined as \\>= 2-point decrease from baseline in score (maintained for 2 consecutive assessments at least 3 weeks apart). Time to symptomatic progression was defined as the time from randomization to date of symptoms worsening. For participants with no symptom progression, the date of the last symptom assessment was used. See also Outcome Measure 15.', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who completed baseline FACT-LCS questionnaire (ie, completed questionnaire \\<=14 days prior to treatment, or if they were never treated, \\<=14 days prior to randomization) and who had a baseline score greater than or equal to 2. As the median was not reached, no data are presented here (see Outcome Measure 15).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died, or Experienced Other Serious Adverse Events (SAEs) and Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}, {'title': 'Adverse events', 'categories': [{'measurements': [{'value': '324', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). An SAE was defined as an AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants. The AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing AEs Leading to Study Drug Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'title': 'Cetuximab', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Taxane', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Carboplatin', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). The results presented are stratified according to which drug was discontinued.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Other Significant AEs: Acneform Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term "acneform rash" were of particular importance. These AEs were: rash, rash pustular, rash erythematous, dermatitis acneiform, dermatitis exfoliative, rash papular, rash pruritic, rash generalised, rash macular, rash maculo-papular, acne, acne pustular, skin desquamation and dry skin.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Other Significant AEs: Infusion Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).', 'description': 'AE=any new untoward medical occurrence or worsening of pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term "infusion reaction" were of particular importance. These AEs were: infusion-related reaction, hypersensitivity, anaphylactic reaction, anaphylactic shock, and anaphylactoid reaction regardless of when they occurred. The terms dyspnea, pyrexia and chills were also grouped under infusion reaction, provided the onset date of these toxicities occurred on the first day of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Other Significant AEs: Cardiac AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term "cardiac AE" were of particular importance. These AEs, coded as preferred or other level Medical Dictionary for Regulatory Activities \\[MedDRA\\] terms were: coronary artery disorders, cardiac arrhythmias, heart failures not elsewhere classified, left ventricular failures, sudden cardiac death, cardiac death and sudden death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Exprienced the Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=5% Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}]}, {'title': 'Leukopenia', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Anemia', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).', 'description': 'Abnormalities were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. The scale is graded from 1 (least severe) to 4 (life threatening). Grade 3 and 4 criteria are defined as follows: Neutropenia: Grade 3, neutrophils \\<1.0 - 0.5 x 10\\^9/L; Grade 4, \\<0.5 x 10\\^9/L. Leukopenia: Grade 3, leukocytes \\<2.0 - 1.0 x 10\\^9/L; Grade 4, \\<1.0 x 10\\^9/L. Thrombocytopenia: Grade 3, platelets \\<50.0 - 25.0 x 10\\^9/L; Grade 4, \\<25.0 x 10\\^9/L. Anemia: Grade 3, hemoglobin \\<4.9 - 4.0 millimoles (mmol)/L, Grade 4, \\<4.0 mmol/L.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Median Change From Baseline in Symptoms, by Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'title': '3 weeks (n = 286, 257)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '3.0'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '3.0'}]}]}, {'title': '6 weeks (n = 254, 221)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '4.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '4.0'}]}]}, {'title': '9 weeks (n = 203, 175)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '4.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '4.0'}]}]}, {'title': '12 weeks (n = 178, 161)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '4.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '4.0'}]}]}, {'title': '15 weeks (n = 155, 121)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '4.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '5.0'}]}]}, {'title': '18 weeks (n = 126, 91)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '5.0'}]}]}, {'title': '21 weeks (n = 96, 43)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '7.0'}]}]}, {'title': '24 weeks (n = 90, 41)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '5.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '5.0'}]}]}, {'title': '27 weeks (n = 60, 22)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '5.0'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '7.0'}]}]}, {'title': '30 weeks (n = 56, 15)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '5.0'}]}]}, {'title': '33 weeks (n = 43, 7)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '6.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).', 'description': 'Symptoms were assessed using the FACT-LCS questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic) to 28 (symptom-free). The median change from baseline score was calculated at 3-weekly intervals. See also Outcome Measure 8.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who completed a baseline FACT-LCS questionnaire (ie, completed questionnaire \\<=14 days prior to treatment, or if they were never treated, \\<=14 days prior to randomization). n = number of participants with a score at both the baseline and at the specified time point (each arm respectively).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced the Most Frequent Grade 3-4 Serum Chemistry Abnormalities Occurring in >=5% Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'classes': [{'title': 'Hyperglycemia (non-fasting)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Hypomagnesemia', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Low albumin', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).', 'description': 'Abnormalities were graded according to the NCI CTC, version 3.0. The scale is graded from 1 (least severe) to 4 (life threatening). Grade 3 and 4 criteria are defined as follows: Hyperglycemia (non-fasting): Grade 3, serum glucose \\>13.9 - 27.8 mmol/L; Grade 4 \\>27.8 mmol/L or acidosis. Hypomagnesemia: Grade 3, serum magnesium \\>1.23 - 3.30 mmol/L; Grade 4 \\>3.30 mmol/L. Hyponatremia: Grade 3, serum sodium \\<130 - 120 mmol/L; Grade 4 \\<120 mmol/L. Low albumin: Grade 3, serum albumin \\<20 g/L; Grade 4 not applicable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Unscheduled Visits to Physicians, Clinics, Hospitals and Other Unscheduled Major Medicinal Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'OG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'timeFrame': 'Day 1 of each cycle of treatment, at the end of study therapy evaluation and at the first follow-up visit (6 weeks after the end of study therapy evaluation).', 'description': 'Participants were to complete log to collect information on unscheduled visits to physicians,clinics,hospitals \\& other unscheduled major procedures.If asked, participants were to complete and return log to site upon routinely scheduled visits.The purpose of this exploratory analysis was to understand the economical implications as a secondary objective.This was not a pivotal study \\& therefore not needed to support any arguments with regulatory authorities concerning cost-benefit,hence,it was not necessary to conduct this analysis. There is no intent on conducting this analysis in the future.', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'FG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '338 randomized and 325 treated.', 'groupId': 'FG000', 'numSubjects': '325'}, {'comment': '338 randomized and 320 treated.', 'groupId': 'FG001', 'numSubjects': '320'}]}, {'type': 'Never Treated', 'achievements': [{'comment': 'Number by randomized group = 11, but 2 participants received C/T/C instead of T/C.', 'groupId': 'FG000', 'numSubjects': '13'}, {'comment': 'Number by randomized group = 20, but 2 participants received C/T/C instead of T/C.', 'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Off all study therapies.', 'groupId': 'FG000', 'numSubjects': '320'}, {'comment': 'Off all study therapies.', 'groupId': 'FG001', 'numSubjects': '320'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Still on study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '755 participants were enrolled and 676 were randomized into the study. 79 participants were not randomized (6 deaths; 1 lost to follow up; 1 poor/non-compliance; 49 no longer met study criteria; 17 participant request; 2 required concurrent radiation; 1 insurance issue; 1 doctor discretion; 1 unknown).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '676', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'BG001', 'title': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '63.9', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '64.0', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '340', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '596', 'groupId': 'BG002'}]}]}, {'title': 'Other race', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "'Other race' includes 1 American Indian or Alaska native and 3 native Hawaiian or other pacific islander.", 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)', 'classes': [{'title': '0=fully active', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}]}, {'title': '1=restricted physically strenuous activity', 'categories': [{'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}]}, {'title': '2=ambulatory but unable to work', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': '3=capable of only limited self care', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '4=completely disabled', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '5=dead', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The ECOG PS is used to assess disease severity. A score of 0 is fully active; 1 is restricted physically strenuous activity; 2 is ambulatory but unable to work; 3 is capable of only limited self care; 4 is completely disabled; 5 is dead. Missing includes participants whose pre-treatment PS \\> 14 days prior to first dose.', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'spread': '17.1', 'groupId': 'BG000'}, {'value': '75.3', 'spread': '18.1', 'groupId': 'BG001'}, {'value': '75.1', 'spread': '17.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '3 participants in the C/T/C group did not have values for this measure. 1 participant in the C/T group did not have a value for this measure.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 755}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-24', 'studyFirstSubmitDate': '2005-06-01', 'resultsFirstSubmitDate': '2010-06-30', 'studyFirstSubmitQcDate': '2005-06-01', 'lastUpdatePostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-09-07', 'studyFirstPostDateStruct': {'date': '2005-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Median Change From Baseline in Symptoms, by Time Point', 'timeFrame': 'From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).', 'description': 'Symptoms were assessed using the FACT-LCS questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic) to 28 (symptom-free). The median change from baseline score was calculated at 3-weekly intervals. See also Outcome Measure 8.'}], 'primaryOutcomes': [{'measure': 'Median Number of Months of Progression-free Survival (PFS)', 'timeFrame': 'From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months).', 'description': 'Interval between randomization date \\& earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): \\>=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments \\& were still alive, date of randomization used.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'From randomization to end of study drug therapy (up to 174 weeks).', 'description': 'Tumor response was defined as the number of participants whose best response was CR or PR, per the IRRC assessment, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR: \\>= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present.'}, {'measure': 'Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD)', 'timeFrame': 'From randomization to end of study drug therapy (up to 174 weeks).', 'description': 'Disease control was defined as the number of participants whose best response was CR, PR, or SD, per the IRRC assessment, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR:\\>= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression (to qualify as CR or PR, no new lesions could be present); SD: participants who did not meet the criteria for CR, PR, or PD (PD:\\>=25% increase in SOPD of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion).'}, {'measure': 'Median Number of Months of Response', 'timeFrame': 'Time from first occurrence of CR or PR (whichever was recorded first) to the date of PD, death or date of last tumor assessment (up to 19 months).', 'description': 'Median number of months of response (time from first occurrence of CR/PR to date of PD/death, \\[per IRRC assessment,using modified WHO criteria\\]) calculated for participants whose best response=CR/PR.For participants who did not progress/die, date of last tumor assessment used.CR:disappearance of all index/non-index lesions;PR:\\>= 50% reduction in SOPD of index lesions compared with baseline, no evidence of progression.No new lesions present.PD:\\>=25% increase in SOPD of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion.'}, {'measure': 'Median Number of Months to Response', 'timeFrame': 'Time from first dose of study therapy to the date of PR or CR, whichever occurred first (up to 13 months).', 'description': 'The median number of months to response was calculated for participants whose best response was CR or PR. It was defined as the time from the first dose of study therapy to the first date that criteria for PR or CR (whichever occurred first)were met. Response was assessed by the IRRC, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR: \\>= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present.'}, {'measure': 'Median Number of Months of Survival', 'timeFrame': 'From randomization to death or date of last contact (up to 41 months).', 'description': 'The median number of months of survival was defined as the time from randomization to the date of death. For participants who did not die, the date of last contact was used.'}, {'measure': 'Number of Participants With Improvement of Symptoms', 'timeFrame': 'From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).', 'description': 'Symptoms were assessed using the Functional Assessment of Cancer Therapy - Lung Cancer Subscale (FACT-LCS) questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic in all symptoms assessed) to 28 (symptom-free on all symptoms assessed). Symptom response (improvement) was defined as \\>= 2-point increase from baseline in score (maintained for 2 consecutive assessments, at least 3 weeks apart). Participants with a baseline score of \\>= 27 were not evaluable, as it would not have been possible to show an improvement. Participants with no baseline data were also not evaluable.'}, {'measure': 'Median Number of Months Until Symptomatic Progression (Worsening of Symptoms)', 'timeFrame': 'From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).', 'description': 'Symptoms were assessed using the FACT-LCS questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic) to 28 (symptom-free). Symptomatic progression was defined as \\>= 2-point decrease from baseline in score (maintained for 2 consecutive assessments at least 3 weeks apart). Time to symptomatic progression was defined as the time from randomization to date of symptoms worsening. For participants with no symptom progression, the date of the last symptom assessment was used. See also Outcome Measure 15.'}, {'measure': 'Number of Participants Who Died, or Experienced Other Serious Adverse Events (SAEs) and Adverse Events (AEs)', 'timeFrame': 'From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). An SAE was defined as an AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event.'}, {'measure': 'Number of Participants Experiencing AEs Leading to Study Drug Discontinuation', 'timeFrame': 'From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). The results presented are stratified according to which drug was discontinued.'}, {'measure': 'Number of Participants Experiencing Other Significant AEs: Acneform Rash', 'timeFrame': 'From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term "acneform rash" were of particular importance. These AEs were: rash, rash pustular, rash erythematous, dermatitis acneiform, dermatitis exfoliative, rash papular, rash pruritic, rash generalised, rash macular, rash maculo-papular, acne, acne pustular, skin desquamation and dry skin.'}, {'measure': 'Number of Participants Experiencing Other Significant AEs: Infusion Reaction', 'timeFrame': 'From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).', 'description': 'AE=any new untoward medical occurrence or worsening of pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term "infusion reaction" were of particular importance. These AEs were: infusion-related reaction, hypersensitivity, anaphylactic reaction, anaphylactic shock, and anaphylactoid reaction regardless of when they occurred. The terms dyspnea, pyrexia and chills were also grouped under infusion reaction, provided the onset date of these toxicities occurred on the first day of study treatment.'}, {'measure': 'Number of Participants Experiencing Other Significant AEs: Cardiac AEs', 'timeFrame': 'From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term "cardiac AE" were of particular importance. These AEs, coded as preferred or other level Medical Dictionary for Regulatory Activities \\[MedDRA\\] terms were: coronary artery disorders, cardiac arrhythmias, heart failures not elsewhere classified, left ventricular failures, sudden cardiac death, cardiac death and sudden death.'}, {'measure': 'Number of Participants Who Exprienced the Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=5% Participants', 'timeFrame': 'From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).', 'description': 'Abnormalities were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. The scale is graded from 1 (least severe) to 4 (life threatening). Grade 3 and 4 criteria are defined as follows: Neutropenia: Grade 3, neutrophils \\<1.0 - 0.5 x 10\\^9/L; Grade 4, \\<0.5 x 10\\^9/L. Leukopenia: Grade 3, leukocytes \\<2.0 - 1.0 x 10\\^9/L; Grade 4, \\<1.0 x 10\\^9/L. Thrombocytopenia: Grade 3, platelets \\<50.0 - 25.0 x 10\\^9/L; Grade 4, \\<25.0 x 10\\^9/L. Anemia: Grade 3, hemoglobin \\<4.9 - 4.0 millimoles (mmol)/L, Grade 4, \\<4.0 mmol/L.'}, {'measure': 'Number of Participants Who Experienced the Most Frequent Grade 3-4 Serum Chemistry Abnormalities Occurring in >=5% Participants', 'timeFrame': 'From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).', 'description': 'Abnormalities were graded according to the NCI CTC, version 3.0. The scale is graded from 1 (least severe) to 4 (life threatening). Grade 3 and 4 criteria are defined as follows: Hyperglycemia (non-fasting): Grade 3, serum glucose \\>13.9 - 27.8 mmol/L; Grade 4 \\>27.8 mmol/L or acidosis. Hypomagnesemia: Grade 3, serum magnesium \\>1.23 - 3.30 mmol/L; Grade 4 \\>3.30 mmol/L. Hyponatremia: Grade 3, serum sodium \\<130 - 120 mmol/L; Grade 4 \\<120 mmol/L. Low albumin: Grade 3, serum albumin \\<20 g/L; Grade 4 not applicable.'}, {'measure': 'Number of Participants Who Had Unscheduled Visits to Physicians, Clinics, Hospitals and Other Unscheduled Major Medicinal Procedures', 'timeFrame': 'Day 1 of each cycle of treatment, at the end of study therapy evaluation and at the first follow-up visit (6 weeks after the end of study therapy evaluation).', 'description': 'Participants were to complete log to collect information on unscheduled visits to physicians,clinics,hospitals \\& other unscheduled major procedures.If asked, participants were to complete and return log to site upon routinely scheduled visits.The purpose of this exploratory analysis was to understand the economical implications as a secondary objective.This was not a pivotal study \\& therefore not needed to support any arguments with regulatory authorities concerning cost-benefit,hence,it was not necessary to conduct this analysis. There is no intent on conducting this analysis in the future.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-Small Cell Lung Cancer'], 'conditions': ['Non-Small-Cell Lung Carcinoma']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.\n* Tumor/disease lesions that can be measured bidimensionally.\n* Must be able to carry-out work of light or sedentary nature (e.g. light house work, office work).\n* Adequate recovery from recent surgery or radiation therapy.\n* Must be at least 4 weeks from last major surgery or prior treatment with an investigational agent. At least 12 weeks from any radiation therapy to chest.\n* Accessible for treatment, follow-up and required visits at a participating center(s).\n\nExclusion Criteria:\n\n* Prior chemotherapy or adjuvant chemotherapy for the treatment of lung cancer.\n* Prior treatment with cetuximab or other epidermal growth factor (EGFR)-targeted therapy.\n* Prior severe infusion reaction to antibody therapy.\n* Concurrent malignancy (previous malignancy without evidence of disease for 5 years will be allowed to enter trial).\n* Concurrent chemotherapy or therapy with another investigational agent not indicated in the protocol.\n* Serious uncontrolled medical disorders that would impair the ability to receive therapy.\n* History of myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure.\n* Symptomatic or uncontrolled metastases in the central nervous system. Subjects receiving a glucocorticoid for central nervous system (CNS) metastases are not eligible, but those receiving an anticonvulsant are eligible.\n* Peripheral neuropathy \\>= grade 2 (Common Toxicity Criteria Adverse Event \\[CTCAE\\] Version 3.0).\n* Inadequate hematologic and/or liver and/or kidney function.\n* Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for entire trial and up to 4 weeks after the study.\n* Women who are pregnant or breastfeeding.\n* Women with a positive pregnancy test on enrollment prior to study drug administration.\n* Altered mental status or psychiatric condition that prohibits understanding or rendering of consent.'}, 'identificationModule': {'nctId': 'NCT00112294', 'briefTitle': 'Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized Multicenter Phase III Study of Taxane/Carboplatin/Cetuximab Versus Taxane/Carboplatin as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CA225-099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cetuximab+Taxane+Carboplatin (C/T/C)', 'description': 'Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\\^2 intravenous (IV) infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.', 'interventionNames': ['Drug: Paclitaxel (Taxane)', 'Drug: Docetaxel (Taxane)', 'Drug: Carboplatin', 'Drug: Cetuximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Taxane+Carboplatin (T/C)', 'description': 'A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.', 'interventionNames': ['Drug: Paclitaxel (Taxane)', 'Drug: Docetaxel (Taxane)', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Paclitaxel (Taxane)', 'type': 'DRUG', 'description': 'IV, 225 mg/m\\^2', 'armGroupLabels': ['Cetuximab+Taxane+Carboplatin (C/T/C)', 'Taxane+Carboplatin (T/C)']}, {'name': 'Docetaxel (Taxane)', 'type': 'DRUG', 'description': 'IV, 75 mg/m\\^2', 'armGroupLabels': ['Cetuximab+Taxane+Carboplatin (C/T/C)', 'Taxane+Carboplatin (T/C)']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'AUC=6, q 3 weeks (6 cycles maximum)', 'armGroupLabels': ['Cetuximab+Taxane+Carboplatin (C/T/C)', 'Taxane+Carboplatin (T/C)']}, {'name': 'Cetuximab', 'type': 'DRUG', 'otherNames': ['Erbitux'], 'description': 'Intravenous, 400 mg/m\\^2, initial dose followed by 250 mg/m\\^2, weekly starting on Week 2', 'armGroupLabels': ['Cetuximab+Taxane+Carboplatin (C/T/C)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'city': 'Gilroy', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.00578, 'lon': -121.56828}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Montebello', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': 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