Viewing Study NCT00547157

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Ignite Creation Date: 2025-12-24 @ 6:31 PM
Ignite Modification Date: 2026-01-28 @ 12:16 AM
Study NCT ID: NCT00547157
Status: COMPLETED
Last Update Posted: 2017-03-15
First Post: 2007-10-18
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Czechia', 'Mexico', 'Poland', 'Spain', 'Switzerland', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077544', 'term': 'Panitumumab'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The median reporting period was around 74 days in the Panitumumab Plus Radiotherapy arm, and around 74 days in the Chemoradiotherapy arm.', 'description': 'The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One Subject who was randomized to Panitumumab+Radiotherapy but received Chemotherapy+Radiotherapy was summarized under Chemotherapy+Radiotherapy arm. So the number of participants under Chemotherapy+Radiotherapy arm is 62 (61+1).', 'eventGroups': [{'id': 'EG000', 'title': 'Panitumumab Plus Radiotherapy', 'description': 'Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy', 'otherNumAtRisk': 89, 'otherNumAffected': 88, 'seriousNumAtRisk': 89, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Chemotherapy Plus Radiotherapy', 'otherNumAtRisk': 62, 'otherNumAffected': 61, 'seriousNumAtRisk': 62, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Radiation mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Radiation skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 35}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ageusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Aphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastric perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Feeding tube complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Radiation skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Leukocytoclastic vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Local Regional Control Rate at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panitumumab Plus Radiotherapy', 'description': 'Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy'}, {'id': 'OG001', 'title': 'Chemoradiotherapy', 'description': 'Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.40', 'upperLimit': '0.62'}, {'value': '0.61', 'groupId': 'OG001', 'lowerLimit': '0.47', 'upperLimit': '0.72'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.07', 'estimateComment': 'difference is PRT - CRT', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'from study day 1 to 2 years', 'description': "Kaplan-Meier estimate of Local regional control rate at 2 years. Local regional control rate will be measured according to the investigator's assessment of disease status based on all available data (ie, from clinical examination, radiologic assessments, pathology reports, and autopsy reports).", 'unitOfMeasure': 'Proportion of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set'}, {'type': 'SECONDARY', 'title': 'Duration of Local Regional Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panitumumab Plus Radiotherapy', 'description': 'Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy'}, {'id': 'OG001', 'title': 'Chemoradiotherapy', 'description': 'Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '36.0'}, {'value': 'NA', 'comment': 'median time to event was not reached.', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0601', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.613', 'ciLowerLimit': '0.980', 'ciUpperLimit': '2.656', 'estimateComment': 'Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'maximum follow up time 46.2 months', 'description': 'Time from study day 1 to the date of first local-regional failure or to death due to any cause (whichever occurs first)', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panitumumab Plus Radiotherapy', 'description': 'Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy'}, {'id': 'OG001', 'title': 'Chemoradiotherapy', 'description': 'Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '27.0'}, {'value': 'NA', 'comment': 'median time to event was not reached.', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0259', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.731', 'ciLowerLimit': '1.068', 'ciUpperLimit': '2.806', 'estimateComment': 'Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'maximum follow up time 46.2 months', 'description': 'Time from first dose date till disease progression or death', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis set'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panitumumab Plus Radiotherapy', 'description': 'Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy'}, {'id': 'OG001', 'title': 'Chemoradiotherapy', 'description': 'Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'comment': 'The value is not estimable.', 'groupId': 'OG000', 'lowerLimit': '27.2', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'median time to event was not reached.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.1039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.593', 'ciLowerLimit': '0.909', 'ciUpperLimit': '2.793', 'estimateComment': 'Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'maximum follow up time 46.2 months', 'description': 'Time from first dose date to death', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set'}, {'type': 'SECONDARY', 'title': 'ORR by 6 Months - Central', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panitumumab Plus Radiotherapy', 'description': 'Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy'}, {'id': 'OG001', 'title': 'Chemoradiotherapy', 'description': 'Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.722', 'groupId': 'OG000', 'lowerLimit': '0.618', 'upperLimit': '0.812'}, {'value': '0.767', 'groupId': 'OG001', 'lowerLimit': '0.640', 'upperLimit': '0.866'}]}]}], 'analyses': [{'pValue': '0.5744', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.791', 'ciLowerLimit': '0.342', 'ciUpperLimit': '1.785', 'estimateComment': 'The odd ratio is defined as the odds of having an objective response in the panitumumab plus radiotherapy arm relative to the odds in the chemoradiotherapy arm.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in objective response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.044', 'ciLowerLimit': '-0.187', 'ciUpperLimit': '0.112', 'estimateComment': 'Difference is objective response rate in the panitumumab plus radiotherapy arm minus the rate in the chemoradiotherapy arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to 6 months', 'description': 'ORR is Objective Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete or partial response is considered as objective response.', 'unitOfMeasure': 'Proporation of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable for Central Tumor Response Analysis Set: the subset of subjects in the Efficacy Analysis Set with at least one bi-dimensionally measurable leasion at baseline using a modification of the WHO criteria per blinded central review.'}, {'type': 'SECONDARY', 'title': 'CRR by 6 Months - Central', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panitumumab Plus Radiotherapy', 'description': 'Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy'}, {'id': 'OG001', 'title': 'Chemoradiotherapy', 'description': 'Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.144', 'groupId': 'OG000', 'lowerLimit': '0.079', 'upperLimit': '0.234'}, {'value': '0.117', 'groupId': 'OG001', 'lowerLimit': '0.048', 'upperLimit': '0.226'}]}]}], 'analyses': [{'pValue': '0.8070', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.278', 'ciLowerLimit': '0.438', 'ciUpperLimit': '4.043', 'estimateComment': 'The odd ratio is defined as the odds of having an objective response in the panitumumab plus radiotherapy arm relative to the odds in the chemoradiotherapy arm.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in complete response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.029', 'ciLowerLimit': '-0.103', 'ciUpperLimit': '0.141', 'estimateComment': 'Difference is objective response rate in the panitumumab plus radiotherapy arm minus the rate in the chemoradiotherapy arm.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization till 6 months', 'description': 'CRR is Complete Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete Response (CR) is defined as disappearance of all index lesions.', 'unitOfMeasure': 'Proportion of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable for Central Tumor Response Analysis Set: the subset of subjects in the Efficacy Analysis Set with at least one bi-dimensionally measurable leasion at baseline using a modification of the WHO criteria per blinded central review.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Panitumumab Plus Radiotherapy', 'description': 'Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy'}, {'id': 'FG001', 'title': 'Chemoradiotherapy', 'description': 'Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Administrative decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '152 subjects were enrolled with 90 subjects randomized to panitumumab plus radiotherapy arm, and 62 subjects randomized to chemoradiotherapy arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Panitumumab Plus Radiotherpy', 'description': 'Consists of Panitumumab and Radiotherpy'}, {'id': 'BG001', 'title': 'Chemoradiotherapy', 'description': 'Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '57.4', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '57.1', 'spread': '8.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '00', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Radiotherapy Delivery Modality', 'classes': [{'title': 'IMRT', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}, {'title': '3D-CRT', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Tumor Site', 'classes': [{'title': 'Oropharynx/Larynx', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}, {'title': 'Oral Cavity/Hypopharynx', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Nodal Status', 'classes': [{'title': 'N0', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'N+', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'N0: No regional lymph node involvement; N+: Regional lymph node involvement', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor Stage', 'classes': [{'title': 'T1-3', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}, {'title': 'T4', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Tumor stage is determined according to TNM staging system. The tumor, node, and metastasis (TNM) staging system integrates clinical information, including that derived from endoscopy and radiological evaluation. Together the TNM classifications determine the overall clinical stage (I, II, III or IV).', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-07', 'studyFirstSubmitDate': '2007-10-18', 'resultsFirstSubmitDate': '2013-12-16', 'studyFirstSubmitQcDate': '2007-10-18', 'lastUpdatePostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-23', 'studyFirstPostDateStruct': {'date': '2007-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Regional Control Rate at 2 Years', 'timeFrame': 'from study day 1 to 2 years', 'description': "Kaplan-Meier estimate of Local regional control rate at 2 years. Local regional control rate will be measured according to the investigator's assessment of disease status based on all available data (ie, from clinical examination, radiologic assessments, pathology reports, and autopsy reports)."}], 'secondaryOutcomes': [{'measure': 'Duration of Local Regional Control', 'timeFrame': 'maximum follow up time 46.2 months', 'description': 'Time from study day 1 to the date of first local-regional failure or to death due to any cause (whichever occurs first)'}, {'measure': 'Progression-free Survival', 'timeFrame': 'maximum follow up time 46.2 months', 'description': 'Time from first dose date till disease progression or death'}, {'measure': 'Overall Survival', 'timeFrame': 'maximum follow up time 46.2 months', 'description': 'Time from first dose date to death'}, {'measure': 'ORR by 6 Months - Central', 'timeFrame': 'From randomization to 6 months', 'description': 'ORR is Objective Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete or partial response is considered as objective response.'}, {'measure': 'CRR by 6 Months - Central', 'timeFrame': 'From randomization till 6 months', 'description': 'CRR is Complete Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete Response (CR) is defined as disappearance of all index lesions.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['head and neck', 'squamous cell carcinoma', 'radiotherapy', 'chemoradiotherapy', 'panitumumab', 'locally advanced head & neck cancer', 'EGFr', 'epidermal growth factor receptor', 'SCCHN', 'locally advanced SCCHN', 'HNC', 'epidermal growth factor'], 'conditions': ['Cancer', 'Head and Neck Cancer', 'Oncology', 'Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '25596659', 'type': 'BACKGROUND', 'citation': 'Giralt J, Trigo J, Nuyts S, Ozsahin M, Skladowski K, Hatoum G, Daisne JF, Yunes Ancona AC, Cmelak A, Mesia R, Zhang A, Oliner KS, VanderWalde A. Panitumumab plus radiotherapy versus chemoradiotherapy in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-2): a randomised, controlled, open-label phase 2 trial. Lancet Oncol. 2015 Feb;16(2):221-32. doi: 10.1016/S1470-2045(14)71200-8. Epub 2015 Jan 15.'}, {'pmid': '25596660', 'type': 'BACKGROUND', 'citation': 'Mesia R, Henke M, Fortin A, Minn H, Yunes Ancona AC, Cmelak A, Markowitz AB, Hotte SJ, Singh S, Chan AT, Merlano MC, Skladowski K, Zhang A, Oliner KS, VanderWalde A, Giralt J. Chemoradiotherapy with or without panitumumab in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-1): a randomised, controlled, open-label phase 2 trial. Lancet Oncol. 2015 Feb;16(2):208-20. doi: 10.1016/S1470-2045(14)71198-2. Epub 2015 Jan 15.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck (SCCHN). A formal hypothesis will not be tested in this trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.', 'detailedDescription': 'Primary Objective: To estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck (SCCHN).\n\nSecondary Objectives: To estimate the difference between 2 treatment regimens (CRT vs PRT) on other measures of clinical benefit, including LRC, overall response rate (ORR), progression-free survival (PFS), overall survival (OS); and safety.\n\nTertiary Objectives: To estimate the difference in health-related quality of life (HRQoL) and performance status in subjects receiving PRT or CRT.\n\nExploratory Objectives: To investigate potential biomarker development based on assessment of blood and tumor and the proposed mechanism of actions of study drugs. In addition, to investigate the effect of genetic variation in cancer genes and drug target genes on SCCHN and subject response to study drugs (separate informed consent required).\n\nHypothesis: A formal hypothesis will not be tested in this trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.\n\nStudy Design: This is a phase 2, open-label, randomized, multicenter study. Eligible subjects will be randomized in a 2:3 ratio to either of the following regimens:\n\nArm 1 CRT:\n\n* Accelerated fractionation RT: 70 to 72 Gy - delivered over 6 to 6.5 weeks\n* Cisplatin: 100 mg/m2 (given on days 1 and 22 of RT) or\n\nArm 2 PRT:\n\n* Accelerated fractionation RT: 70 to 72 Gy - delivered over 6 to 6.5 weeks\n* Panitumumab: 9.0 mg/kg Q3W (given on days 1, 22, and 43 of RT)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHistologically or cytologically confirmed SCC of the oral cavity, oropharynx, hypopharynx or larynx Stage III or Stage IVa-b (M0) disease according to the American Joint Committee on Cancer staging manual 6th edition (locally advanced) ECOG performance status of 0 or 1 Bidimensionally measurable disease \\>/= 10 mm in at least 1 dimension\n\nExclusion Criteria:\n\nNO Primary tumor of the nasopharynx, sinuses, salivary gland, or skin NO Subjects requiring prophylactic tracheostomy NO Prior (or concomitant) malignancy (except non-melanomatous skin cancer or in situ cervical cancer), other than the study disease (SCCHN), unless treated with curative intent with no evidence of disease for \\>/= 3 years NO Prior treatment for locally advanced SSCHN NO Prior surgery for SCCHN (except nodal sampling or biopsy for study disease) NO Major surgery \\</= 28 days before randomization or minor surgery \\</= 14 days before randomization with the exception of feeding tube placement, dental extractions, central venous catheter placement, biopsies and nodal sampling'}, 'identificationModule': {'nctId': 'NCT00547157', 'briefTitle': 'Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 2 Randomized Trial of Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck', 'orgStudyIdInfo': {'id': '20062079'}, 'secondaryIdInfos': [{'id': 'CONCERT2'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ARM 1 CRT', 'description': 'Cisplatin plus RT', 'interventionNames': ['Drug: Cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'ARM 2 PRT', 'description': 'Panitumumab plus RT', 'interventionNames': ['Drug: Panitumumab']}], 'interventions': [{'name': 'Panitumumab', 'type': 'DRUG', 'otherNames': ['Panitumumab (drug)'], 'description': 'Arm 2 consists of panitmumab plus RT', 'armGroupLabels': ['ARM 2 PRT']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Cisplatin (Chemotherapy)'], 'description': 'Cisplatin', 'armGroupLabels': ['ARM 1 CRT']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}