Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT00084318
Status:
COMPLETED
Last Update Posted:
2018-12-12
First Post:
2004-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D011878', 'term': 'Radiotherapy'}], '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': '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': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'seiferheldw@nrgoncology.org', 'title': 'Wendy Seiferheld, M.S.', 'organization': 'NRG Oncology'}, 'certainAgreement': {'otherDetails': "PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'RT+Cisplatin+Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.', 'otherNumAtRisk': 97, 'otherNumAffected': 97, 'seriousNumAtRisk': 97, 'seriousNumAffected': 42}, {'id': 'EG001', 'title': 'RT+Docetaxel+Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.', 'otherNumAtRisk': 106, 'otherNumAffected': 105, 'seriousNumAtRisk': 106, 'seriousNumAffected': 56}], 'otherEvents': [{'term': 'Blood/bone marrow - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 55}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Auditory/ear - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 10}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 15}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 85}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 86}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophageal stenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophagitis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 49}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Radiation mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 65}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Salivary gland disorder NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth disorder NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema: head and neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 83}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rigors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gingival infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis radiation NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 47}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Radiation recall syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic/laboratory - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 43}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 41}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibrosis-cosmesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibrosis-deep connective tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle weakness NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal/soft tissue - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Trismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 52}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngeal edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngitis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis/stomatitis (clinical exam): Pharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis/stomatitis (functional/symptomatic): Pharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acne NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 57}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis exfoliative NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 33}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 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{'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibrosis-deep connective tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal/soft tissue - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Trismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurology - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal failure NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal/genitourinary - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngeal edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngitis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis/stomatitis (clinical exam): Pharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis/stomatitis (functional/symptomatic): Pharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngeal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonitis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary/upper respiratory - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acne NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis exfoliative NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatology/skin - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fat atrophy NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nail disorder NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain: Scalp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Photosensitivity reaction NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin hypopigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Telangiectasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RT + Cisplatin + Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.'}, {'id': 'OG001', 'title': 'RT + Docetaxel + Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000', 'lowerLimit': '47.4', 'upperLimit': '67.2'}, {'value': '65.9', 'groupId': 'OG001', 'lowerLimit': '56.9', 'upperLimit': '75'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.06', 'groupDescription': 'Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method. \\[RTOG = Radiation Therapy Oncology Group\\]', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).'}, {'pValue': '0.01', 'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.96', 'groupDescription': 'Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to 2 years', 'description': 'Two-year rates are shown (Kaplan-Meier estimates). Disease-free survival is defined as the time from randomization to local, regional, or distant progression, second primary, or death (event) or last follow-up (censored). Response criteria as follows: No evidence of disease (NED): All patients must have no measurable tumor following surgery; Local-Regional Relapse: Recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; biopsy confirmation is necessary; Distant Relapse: Clear evidence of distant metastases (lung, bone, brain, etc.); Biopsy is recommended where possible. A solitary lung mass/nodule is considered a second primary neoplasm unless proven otherwise.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started protocol treatment and did not withdraw consent.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RT + Cisplatin + Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.'}, {'id': 'OG001', 'title': 'RT + Docetaxel + Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000', 'lowerLimit': '59.5', 'upperLimit': '78'}, {'value': '79.2', 'groupId': 'OG001', 'lowerLimit': '71.4', 'upperLimit': '86.9'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.03', 'estimateComment': 'Reference arm = historical control', 'groupDescription': 'Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model. \\[RTOG = Radiation Therapy Oncology Group\\]', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).'}, {'pValue': '0.001', 'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.39', 'ciUpperLimit': '0.82', 'estimateComment': 'Reference arm = historical control', 'groupDescription': 'Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to 2 years', 'description': 'Two-year rates are shown (Kaplan-Meier estimates). Overall survival is defined as the time from randomization to death (event) or last follow-up (censored).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started protocol treatment and did not withdraw consent'}, {'type': 'SECONDARY', 'title': 'Treatment Tolerance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RT+Cisplatin+Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.'}, {'id': 'OG001', 'title': 'RT+Docetaxel+Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.4', 'groupId': 'OG000', 'lowerLimit': '72.5', 'upperLimit': '88.3'}, {'value': '84.9', 'groupId': 'OG001', 'lowerLimit': '78.1', 'upperLimit': '91.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to end of treatment (protocol treatment lasts seven weeks).', 'description': 'Tolerability was defined as having received 90% of the radiation dose, 95% of the cetuximab loading dose, and at least 4 weeks of cetuximab and cisplatin or docetaxel at doses 95% of the protocol prescription. The percentage of patients determined to be tolerant of treatment are shown.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started protocol treatment and did not withdraw consent'}, {'type': 'SECONDARY', 'title': 'Frequency of Toxicity (Grade 5 and Acute Non-hematologic Grade 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RT+Cisplatin+Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.'}, {'id': 'OG001', 'title': 'RT+Docetaxel+Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '15.1'}, {'value': '12.3', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '18.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to last follow-up. Analysis occurs at the time of the primary analysis.', 'description': 'Each regimen was monitored for excessive acute toxicity (defined as nonhematologic grade 4 toxicity within 90 days of the start of radiation or any grade 5 toxicity). The target rate was based on the observed rate from RTOG-9501/NCT00002670 of 15%. The unacceptable rate was \\>30%. \\[RTOG = Radiation Therapy Oncology Group\\]', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started protocol treatment and did not withdraw consent'}, {'type': 'SECONDARY', 'title': 'Frequency of Other Acute and Late Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RT+Cisplatin+Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.'}, {'id': 'OG001', 'title': 'RT+Docetaxel+Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000'}, {'value': '73.6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}, {'value': '16.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to last follow-up. Analysis occurs at the time of the primary endpoint analysis.', 'description': 'Maximum grade toxicity that is definitely, probably, or possibly related to protocol treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started protocol treatment and did not withdraw consent'}, {'type': 'SECONDARY', 'title': 'Local-regional Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RT + Cisplatin + Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.'}, {'id': 'OG001', 'title': 'RT + Docetaxel + Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '27.8'}, {'value': '18.9', 'groupId': 'OG001', 'lowerLimit': '13.4', 'upperLimit': '24.3'}]}]}], 'analyses': [{'pValue': '0.66', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.76', 'estimateComment': 'Reference arm = historical control', 'groupDescription': "Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model. \\[RTOG = Radiation Therapy Oncology Group\\]", 'statisticalMethod': "Gray's test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)'}, {'pValue': '0.86', 'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.87', 'estimateComment': 'Reference arm = historical control', 'groupDescription': "Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model.", 'statisticalMethod': "Gray's test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to 2 years', 'description': 'Two-year rate is shown (cumulative incidence estimate). Local-regional failure is defined as the time from randomization to local-regional recurrence (event), death (competing risk), or last follow-up (censored).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started protocol treatment and did not withdraw consent.'}, {'type': 'SECONDARY', 'title': 'Correlation of EGFR (Total and Phosphorylated) pMAPK, pAKT, Stat-3, KI-67, COX-2, and Cyclin B1 Expression With Local-regional Control, and Overall and Disease-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RT + Cisplatin + Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.'}, {'id': 'OG001', 'title': 'RT + Docetaxel + Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.'}], 'timeFrame': 'From randomization to two years', 'reportingStatus': 'POSTED', 'populationDescription': 'Effective and reliable assessment of nuclear expression of these receptors was not achieved and therefore no data was available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RT + Cisplatin + Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.'}, {'id': 'FG001', 'title': 'RT + Docetaxel + Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Subjects with data available for the primary analysis are considered to have completed the study.', 'groupId': 'FG000', 'numSubjects': '97'}, {'comment': 'Subjects with data available for the primary analysis are considered to have completed the study.', 'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'No protocol treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RT + Cisplatin + Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.'}, {'id': 'BG001', 'title': 'RT + Docetaxel + Cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '80'}, {'value': '55', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '79'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Eligible patients who started protocol treatment and did not withdraw consent.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-15', 'studyFirstSubmitDate': '2004-06-10', 'resultsFirstSubmitDate': '2016-06-14', 'studyFirstSubmitQcDate': '2004-06-10', 'lastUpdatePostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-18', 'studyFirstPostDateStruct': {'date': '2004-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free Survival', 'timeFrame': 'From randomization to 2 years', 'description': 'Two-year rates are shown (Kaplan-Meier estimates). Disease-free survival is defined as the time from randomization to local, regional, or distant progression, second primary, or death (event) or last follow-up (censored). Response criteria as follows: No evidence of disease (NED): All patients must have no measurable tumor following surgery; Local-Regional Relapse: Recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; biopsy confirmation is necessary; Distant Relapse: Clear evidence of distant metastases (lung, bone, brain, etc.); Biopsy is recommended where possible. A solitary lung mass/nodule is considered a second primary neoplasm unless proven otherwise.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From randomization to 2 years', 'description': 'Two-year rates are shown (Kaplan-Meier estimates). Overall survival is defined as the time from randomization to death (event) or last follow-up (censored).'}, {'measure': 'Treatment Tolerance', 'timeFrame': 'From start of treatment to end of treatment (protocol treatment lasts seven weeks).', 'description': 'Tolerability was defined as having received 90% of the radiation dose, 95% of the cetuximab loading dose, and at least 4 weeks of cetuximab and cisplatin or docetaxel at doses 95% of the protocol prescription. The percentage of patients determined to be tolerant of treatment are shown.'}, {'measure': 'Frequency of Toxicity (Grade 5 and Acute Non-hematologic Grade 4)', 'timeFrame': 'From start of treatment to last follow-up. Analysis occurs at the time of the primary analysis.', 'description': 'Each regimen was monitored for excessive acute toxicity (defined as nonhematologic grade 4 toxicity within 90 days of the start of radiation or any grade 5 toxicity). The target rate was based on the observed rate from RTOG-9501/NCT00002670 of 15%. The unacceptable rate was \\>30%. \\[RTOG = Radiation Therapy Oncology Group\\]'}, {'measure': 'Frequency of Other Acute and Late Toxicity', 'timeFrame': 'From start of treatment to last follow-up. Analysis occurs at the time of the primary endpoint analysis.', 'description': 'Maximum grade toxicity that is definitely, probably, or possibly related to protocol treatment.'}, {'measure': 'Local-regional Control', 'timeFrame': 'From randomization to 2 years', 'description': 'Two-year rate is shown (cumulative incidence estimate). Local-regional failure is defined as the time from randomization to local-regional recurrence (event), death (competing risk), or last follow-up (censored).'}, {'measure': 'Correlation of EGFR (Total and Phosphorylated) pMAPK, pAKT, Stat-3, KI-67, COX-2, and Cyclin B1 Expression With Local-regional Control, and Overall and Disease-free Survival', 'timeFrame': 'From randomization to two years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage III squamous cell carcinoma of the hypopharynx', 'stage IV squamous cell carcinoma of the hypopharynx', 'stage III squamous cell carcinoma of the oropharynx', 'stage IV squamous cell carcinoma of the oropharynx', 'stage III squamous cell carcinoma of the larynx', 'stage IV squamous cell carcinoma of the larynx', 'stage III lymphoepithelioma of the oropharynx', 'stage IV lymphoepithelioma of the oropharynx'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Harari PM, Harris J, Kies MS, et al.: Phase II randomized trial of surgery followed by chemoradiation plus cetuximab for high-risk squamous cell carcinoma of the head and neck (RTOG 0234). [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-22, S13, 2007.'}, {'pmid': '25002723', 'type': 'RESULT', 'citation': 'Harari PM, Harris J, Kies MS, Myers JN, Jordan RC, Gillison ML, Foote RL, Machtay M, Rotman M, Khuntia D, Straube W, Zhang Q, Ang K. Postoperative chemoradiotherapy and cetuximab for high-risk squamous cell carcinoma of the head and neck: Radiation Therapy Oncology Group RTOG-0234. J Clin Oncol. 2014 Aug 10;32(23):2486-95. doi: 10.1200/JCO.2013.53.9163. Epub 2014 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Combining a monoclonal antibody with chemoradiotherapy and giving them after surgery may kill any remaining tumor cells.\n\nPURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab given together with chemoradiotherapy using docetaxel in treating patients with resected stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and neck.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare disease-free survival of patients with resected stage III or IV squamous cell carcinoma or lymphoepithelioma of the head and neck treated with adjuvant cetuximab in combination with chemoradiotherapy comprising docetaxel vs cisplatin.\n\nSecondary\n\n* Compare the safety and efficacy of these regimens in these patients.\n* Compare locoregional control and overall survival rates in patients treated with these regimens.\n* Correlate epidermal growth factor receptor (total and phosphorylated), pMAPK, pAKT, Stat-3, Ki-67, cyclo-oxygenase-2, and cyclin B1 expression with outcome in patients treated with these regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1), risk category (positive margins vs high risk \\[i.e., ≥ 2 positive nodes or extracapsular nodal extension\\]) and use of intensity-modulated radiotherapy (no vs yes). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive cetuximab IV over 2 hours on day 1 (week 1). Patients then receive cetuximab IV over 1 hour and cisplatin IV over 1 hour before radiotherapy on days 8, 15, 22, 29, 36, and 43 (weeks 2-7). Patients undergo radiotherapy once daily, 5 days a week, beginning on day 8 for a total of 6 weeks (weeks 2-7).\n* Arm II: Patients receive cetuximab and undergo radiotherapy as in arm I. Patients also receive docetaxel IV over 30 minutes before radiotherapy on days 8, 15, 22, 29, 36, and 43 (weeks 2-7).\n\nTreatment in both arms continues in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 2 years and then every 6 months for 4 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within approximately 29 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed squamous cell carcinoma of the head and neck meeting the following criteria:\n\n * Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding lip, nasopharynx, or sinuses)\n * Gross total resection must be completed within 7 weeks of randomization, with pathology demonstrating one or more of the following risk factors:\n\n * Histologic extracapsular nodal extension\n * Histologic involvement of ≥ 2 regional lymph nodes\n * Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual.\n * Tonsillar cancer patients who undergo transoral excision of all gross tumor are eligible provided extracapsular nodal extension or involvement of ≥ 2 regional lymph nodes is histologically confirmed\n * American Joint Committee on Cancer (AJCC) pathological stage III or IV\n* No evidence of distant metastases\n* No synchronous or concurrent head and neck primary tumors\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Zubrod 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 2,000/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin \\> 8.0 g/dL\n\nHepatic\n\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), and alkaline phosphatase meeting 1 of the following parameters:\n\n * Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN\n * Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN\n * Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN\n\nRenal\n\n* Creatinine ≤ 1.5 mg/dL\n\nCardiovascular\n\n* No unstable angina\n* No uncontrolled hypertension\n* No myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass surgery or percutaneous transluminal coronary angioplasty)\n* No uncontrolled arrhythmia\n* No congestive heart failure\n* No more than 2 heart-related hospitalizations within the past year\n* No other active cardiac disease\n\nPulmonary\n\n* No more than 2 hospitalizations for chronic obstructive pulmonary disease within the past year\n\nNeurologic\n\n* No pre-existing peripheral neuropathy ≥ grade 2\n* No uncontrolled seizure disorder\n* No active neurological disease\n\nOther\n\n* No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80\n* No other invasive malignancy within the past 3 years except nonmelanoma skin cancer\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months after study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior anti-epidermal growth factor receptor antibody therapy\n\nChemotherapy\n\n* More than 3 years since prior cytotoxic chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior head and neck radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n\nOther\n\n* No prior tyrosine kinase inhibitor therapy'}, 'identificationModule': {'nctId': 'NCT00084318', 'briefTitle': 'Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck', 'nctIdAliases': ['NCT00414674'], 'organization': {'class': 'NETWORK', 'fullName': 'Radiation Therapy Oncology Group'}, 'officialTitle': 'A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck', 'orgStudyIdInfo': {'id': 'RTOG-0234'}, 'secondaryIdInfos': [{'id': 'CDR0000360850'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RT + cisplatin + cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.', 'interventionNames': ['Biological: cetuximab', 'Drug: cisplatin', 'Radiation: radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'RT + docetaxel + cetuximab', 'description': 'Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.', 'interventionNames': ['Biological: cetuximab', 'Drug: docetaxel', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'cetuximab', 'type': 'BIOLOGICAL', 'description': '400 mg/m\\^2 intravenously over 120 minutes on day 1 (week 1) followed by 250 mg/m\\^2 intravenously over 60 minutes in weeks 2 through 7.', 'armGroupLabels': ['RT + cisplatin + cetuximab', 'RT + docetaxel + cetuximab']}, {'name': 'cisplatin', 'type': 'DRUG', 'description': '30 mg/m\\^2 intravenously infused over over 60 minutes in weeks 2 through 7.', 'armGroupLabels': ['RT + cisplatin + cetuximab']}, {'name': 'docetaxel', 'type': 'DRUG', 'description': '15 mg/m\\^2 intravenously infused over 30 minutes in weeks 2 through 7.', 'armGroupLabels': ['RT + docetaxel + cetuximab']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': '60 Gy (2 Gy once a day, 5 times a week)', 'armGroupLabels': ['RT + cisplatin + cetuximab', 'RT + docetaxel + cetuximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36652-2144', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Infirmary Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Services Foundation', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Virginia G. 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