Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT01302834
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2011-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], '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'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], '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': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'seiferheldw@nrgoncology.org', 'phone': '215-574-3208', 'title': 'Wendy Seiferheld', '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}, 'limitationsAndCaveats': {'description': 'At the third interim analysis the NRG Oncology Data Monitoring Committee recommended the public release of study results.'}}, 'adverseEventsModule': {'timeFrame': 'From randomization to last follow-up. Maximum follow-up was 7.4 years.', 'description': 'Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event', 'eventGroups': [{'id': 'EG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.', 'otherNumAtRisk': 398, 'deathsNumAtRisk': 406, 'otherNumAffected': 398, 'seriousNumAtRisk': 398, 'deathsNumAffected': 64, 'seriousNumAffected': 177}, {'id': 'EG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.', 'otherNumAtRisk': 394, 'deathsNumAtRisk': 399, 'otherNumAffected': 393, 'seriousNumAtRisk': 394, 'deathsNumAffected': 86, 'seriousNumAffected': 115}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 185}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 118}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 36}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 192}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 104}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 204}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 100}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 10}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 69}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 240}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 214}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 87}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 376}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 372}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 88}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 371}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 351}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastrointestinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 61}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 363}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 370}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 301}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 238}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Salivary duct inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 206}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 150}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 27}], 'organSystem': 'General disorders and administration site conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 357}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 345}], 'organSystem': 'General disorders and administration site conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 46}], 'organSystem': 'General disorders and administration site conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'General disorders and administration site conditions - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 20}], 'organSystem': 'General disorders and administration site conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neck edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 33}], 'organSystem': 'General disorders and administration site conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 329}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 324}], 'organSystem': 'General disorders and administration site conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and infestations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucosal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dermatitis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 316}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 305}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 67}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 53}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Investigations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 101}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 203}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 211}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 157}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 53}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 263}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 253}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 68}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 97}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 101}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 45}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 48}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 66}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 132}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 81}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Metabolism and nutrition disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fibrosis deep connective tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Musculoskeletal and connective tissue disorder - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 44}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neck soft tissue necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Superficial soft tissue fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 48}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Trismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 103}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 349}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 334}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 65}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 62}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 60}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 44}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 118}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 127}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hoarseness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 81}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Laryngeal edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pharyngeal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 116}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 65}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Voice alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 34}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 89}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 140}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 105}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 300}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 96}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin and subcutaneous tissue disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 48}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 49}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Telangiectasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 39}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 37}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Spleen disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cardiac disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Left ventricular systolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Colonic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Colonic perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Esophageal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Esophageal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastric hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastrointestinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Obstruction gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Oral cavity fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Oral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rectal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Retroperitoneal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'General disorders and administration site conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 3}], 'organSystem': 'General disorders and administration site conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 8}], 'organSystem': 'General disorders and administration site conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'General disorders and administration site conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 8}], 'organSystem': 'General disorders and administration site conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Localized edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'General disorders and administration site conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 9}], 'organSystem': 'General disorders and administration site conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sudden death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'General disorders and administration site conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorectal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and infestations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Joint infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucosal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Arterial injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dermatitis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Injury, poisoning and procedural complications - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'CPK increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'INR increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Investigations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Osteonecrosis of jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Trismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Movements involuntary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Myelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Transient ischemic attacks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hallucinations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Laryngeal edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Laryngeal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pharyngeal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pharyngeal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pharyngeal necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Surgical and medical procedures - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vascular disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 394, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '80.6', 'upperLimit': '88.6'}, {'value': '77.9', 'groupId': 'OG001', 'lowerLimit': '73.4', 'upperLimit': '82.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciUpperLimit': '1.94', 'estimateComment': 'Reference level = IMRT + Cisplatin', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin was set at 1.45 (hazard ratio scale; IMRT + Cetuximab / IMRT + Cisplatin). If the upper limit of the 95% confidence interval was \\<1.45, non-inferiority would be concluded. Design was based on a group sequential design with 3 interim analyses, one-sided 0.05, and 80% power.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.', 'description': 'An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000', 'lowerLimit': '73.8', 'upperLimit': '83.0'}, {'value': '67.3', 'groupId': 'OG001', 'lowerLimit': '62.4', 'upperLimit': '72.2'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '1.29', 'ciUpperLimit': '2.29', 'estimateComment': 'Reference level = IMRT + Cisplatin', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Two-sided significance level = 0.05'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.', 'description': 'An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants'}, {'type': 'SECONDARY', 'title': 'Time to Local-regional Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '13.6'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '13.7', 'upperLimit': '21.4'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.05', 'ciLowerLimit': '1.35', 'ciUpperLimit': '3.10', 'estimateComment': 'Reference level = IMRT + Cisplatin', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Two-sided significance level = 0.05'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.', 'description': 'Failure for local-regional failure endpoint was defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \\> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and death due to other causes were considered competing risks. Local-regional failure time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of local-regional failure times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants'}, {'type': 'SECONDARY', 'title': 'Time to Distant Metastasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '11.9'}, {'value': '11.7', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '15.3'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '0.94', 'ciUpperLimit': '2.36', 'pValueComment': 'Two-sided significance level = 0.05', 'estimateComment': 'Reference level = IMRT + Cisplatin', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.', 'description': 'Failure for distant metastasis endpoint was defined as distant progression; local-regional failure and death due to any cause were considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of distant metastasis times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants'}, {'type': 'SECONDARY', 'title': 'Time to Secondary Primary Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '13.4'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '14.2'}]}]}], 'analyses': [{'pValue': '0.95', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.58', 'pValueComment': 'Two-sided significance level = 0.05', 'estimateComment': 'Reference level = IMRT + Cisplatin', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.', 'description': 'Failure for second primary endpoint was defined as reporting of a new primary cancer; death due to any cause was considered a competing risk. Second primary time is defined as time from randomization to the date of second primary or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of second primary cancer times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants'}, {'type': 'SECONDARY', 'title': 'Distribution of First Progression Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'title': 'Local', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Regional', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Local and regional', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Local and distant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Regional and distant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Local, regional, and distant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Distant', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Death, due to this disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Death, due to second primary', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Death, due to other reason', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Death, due to unknown reason', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.', 'description': 'The first event type for progression-free survival is counted for each participant. Possible first progression events are local, regional, or distant progression, any combination of these, or death. The frequency table of these events is also referred to as "Pattern of failure."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants with progression-free survival failure'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Early Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '3.3'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '3.3'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided significance level = 0.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.', 'description': 'Early death is defined as death due to adverse event or within 30 days of treatment completion.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started study treatment'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000', 'lowerLimit': '71.1', 'upperLimit': '79.8'}, {'value': '73.6', 'groupId': 'OG001', 'lowerLimit': '69.0', 'upperLimit': '77.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to end of treatment, approximately 6 weeks', 'description': 'Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who started study treatment'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 1 Month After End of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.5', 'groupId': 'OG000', 'lowerLimit': '27.8', 'upperLimit': '37.6'}, {'value': '31.1', 'groupId': 'OG001', 'lowerLimit': '26.4', 'upperLimit': '36.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to approximately 2.5 months (1 month after the end of treatment)', 'description': 'Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started study treatment and had adverse events assessment at 1 month after treatment end'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 3 Months After the End of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '21.9'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '18.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to approximately 4.5 months (3 months after the end of treatment)', 'description': 'Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started study treatment and had adverse events assessment at 3 months after treatment end'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 6 Months After the End of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '17.2'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '12.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to approximately 7.5 months (6 months after the end of treatment)', 'description': 'Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started study treatment and had adverse events assessment at 6 months year after treatment end'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 1 Year After the End of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '13.6'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '12.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to approximately 13.5 months (one year after the end of treatment)', 'description': 'Late adverse events (AE) are defined as \\> 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started study treatment and had adverse events assessment at 1 year after treatment end'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 2 Years After the End of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '11.3'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '6.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 180 days after end of treatment to two years after end of treatment.', 'description': 'Late adverse events (AE) are defined as \\> 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '.Eligible patients who started study treatment and had adverse events assessment at 2 years after treatment end'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 5 Years After the End of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '10.8'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '14.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment to approximately 61.5 months (five years after the end of treatment)', 'description': 'Late adverse events (AE) are defined as \\> 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started study treatment and had adverse events assessment at 5 years after treatment end'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Feeding Tube at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '12.7'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '11.8'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000'], 'pValueComment': 'Two-sided significance level = 0.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to 1 year.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started study treatment and had feeding tube assessment at 1 year'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-C30 Global Health Status Score Change From Baseline at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.16', 'spread': '28.16', 'groupId': 'OG000'}, {'value': '-25.31', 'spread': '22.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (6-7 weeks)', 'description': "The EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-C30 Global Health Status Score Change From Baseline at 3 Months From End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.42', 'spread': '25.92', 'groupId': 'OG000'}, {'value': '-7.51', 'spread': '22.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months from end of treatment. Treatment lasts 6-7 weeks.', 'description': "The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-C30 Global Health Status Score Change From Baseline at 6 Months From End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.57', 'spread': '25.01', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '23.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5438', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'One-sided significance level = 0.05', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.', 'description': "The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-C30 Global Health Status Score Change From Baseline at 12 Months From End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.15', 'spread': '23.42', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '21.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months from end of treatment. Treatment lasts 6-7 weeks', 'description': "The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-H&N35 Swallowing Score Change From Baseline at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.99', 'spread': '27.99', 'groupId': 'OG000'}, {'value': '47.43', 'spread': '24.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (6-7 weeks)', 'description': 'The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer Module (EORTC QLQ-H\\&N35) swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 3 Months From End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.58', 'spread': '26.49', 'groupId': 'OG000'}, {'value': '14.20', 'spread': '20.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months from end of treatment. Treatment lasts 6-7 weeks.', 'description': 'The EORTC QLQ-H\\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 6 Months From End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.65', 'spread': '23.94', 'groupId': 'OG000'}, {'value': '10.13', 'spread': '18.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7108', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'One-sided significance level = 0.05', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.', 'description': 'The EORTC QLQ-H\\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 12 Months From End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.52', 'spread': '19.64', 'groupId': 'OG000'}, {'value': '7.61', 'spread': '17.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months from end of treatment. Treatment lasts 6-7 weeks.', 'description': 'The EORTC QLQ-H\\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.'}, {'type': 'SECONDARY', 'title': 'Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Head and Neck (PRO-CTCAE H&N) at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.', 'timeFrame': 'From randomization to 1 year after end of treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-06'}, {'type': 'SECONDARY', 'title': 'EuroQol Five Dimension Scale (EQ-5D) at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.', 'timeFrame': 'From randomization to 1 year after end of treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-06'}, {'type': 'SECONDARY', 'title': 'Work Status Questionnaire at Baseline, End of Treatment, 3, 6, and 12 Months.', 'timeFrame': 'From randomization to 1 year after end of treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-06'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Normal/Good Dental Health: Pretreatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '75.5'}, {'value': '74.6', 'groupId': 'OG001', 'lowerLimit': '70.0', 'upperLimit': '78.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before treatment', 'description': 'This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease";\n\n1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \\< 5 restorations indicated; no extractions indicated." Ten year data is not yet available.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started study treatment'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Normal/Good Dental Health: 1 Year After End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000', 'lowerLimit': '82.7', 'upperLimit': '91.0'}, {'value': '83.5', 'groupId': 'OG001', 'lowerLimit': '78.5', 'upperLimit': '87.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year after end of treatment (approximately 13.5 months)', 'description': 'This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease";\n\n1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \\< 5 restorations indicated; no extractions indicated."', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started study treatment and had dental status assessment at 1 year after treatment end'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Normal/Good Dental Health: 2 Years After End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000', 'lowerLimit': '81.1', 'upperLimit': '90.9'}, {'value': '82.1', 'groupId': 'OG001', 'lowerLimit': '76.1', 'upperLimit': '87.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years after end of treatment (approximately 25.5 months)', 'description': 'This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \\< 5 restorations indicated; no extractions indicated."', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started study treatment and had dental status assessment at 2 years after treatment end'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Normal/Good Dental Health: 5 Years After End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000', 'lowerLimit': '75.4', 'upperLimit': '96.2'}, {'value': '86.0', 'groupId': 'OG001', 'lowerLimit': '72.1', 'upperLimit': '94.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years after end of treatment (approximately 61.5 months)', 'description': 'This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \\< 5 restorations indicated; no extractions indicated."', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started study treatment and had dental status assessment at 5 years after treatment end'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Normal/Good Dental Health: 10 Years After End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.2', 'groupId': 'OG000', 'lowerLimit': '76.3', 'upperLimit': '98.1'}, {'value': '84.0', 'groupId': 'OG001', 'lowerLimit': '63.9', 'upperLimit': '95.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 years after end of treatment (approximately 121.5 months)', 'description': 'This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \\< 5 restorations indicated; no extractions indicated."', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who started study treatment and had dental status assessment at 10 years after treatment end', 'anticipatedPostingDate': '2025-12'}, {'type': 'SECONDARY', 'title': 'Number of Participants by HHIA-S Category at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'title': 'No handicap', 'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}, {'title': 'Mild-moderate handicap', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Severe handicap', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': "The Hearing Handicap Inventory for Adults Screen Version (HHIA-S) measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:\n\n* No handicap: 0-8.\n* Mild-moderate handicap: 10-24.\n* Severe handicap: 26-40.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by HHIA-S Category at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'title': 'No handicap', 'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}, {'title': 'Mild-moderate handicap', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Severe handicap', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of treatment (6-7 weeks)', 'description': "The Hearing Handicap Inventory for Adults Screen Version (HHIA-S) measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:\n\n* No handicap: 0-8.\n* Mild-moderate handicap: 10-24.\n* Severe handicap: 26-40.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by HHIA-S Category at 3 Months After End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'title': 'No handicap', 'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}, {'title': 'Mild-moderate handicap', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Severe handicap', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months after end of treatment. Treatment lasts 6-7 weeks.', 'description': "The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:\n\n* No handicap: 0-8.\n* Mild-moderate handicap: 10-24.\n* Severe handicap: 26-40.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by HHIA-S Category at 6 Months After End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'title': 'No handicap', 'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}, {'title': 'Mild-moderate handicap', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Severe handicap', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after end of treatment. Treatment lasts 6-7 weeks.', 'description': "The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:\n\n* No handicap: 0-8.\n* Mild-moderate handicap: 10-24.\n* Severe handicap: 26-40.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by HHIA-S Category at 12 Months After End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'categories': [{'title': 'No handicap', 'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}, {'title': 'Mild-moderate handicap', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Severe handicap', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months after end of treatment. Treatment lasts 6-7 weeks.', 'description': "The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:\n\n* No handicap: 0-8.\n* Mild-moderate handicap: 10-24.\n* Severe handicap: 26-40.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants enrolled to the quality of life (QOL) substudy who received protocol treatment and had outcome measure data.'}, {'type': 'SECONDARY', 'title': 'Overall Survival by KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) Variant Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '470', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Variant', 'description': 'Has the KRAS variant'}, {'id': 'OG001', 'title': 'Non-variant', 'description': 'Does not have the KRAS variant'}], 'classes': [{'categories': [{'measurements': [{'value': '80.6', 'groupId': 'OG000', 'lowerLimit': '72.3', 'upperLimit': '88.9'}, {'value': '79.2', 'groupId': 'OG001', 'lowerLimit': '75.4', 'upperLimit': '83.0'}]}]}], 'analyses': [{'pValue': '0.2571', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.34', 'pValueComment': 'One-sided significance level = 0.025.', 'estimateComment': 'Reference level = non-variant', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by treatment arm.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.', 'description': 'KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments.\n\nAn event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants with KRAS data', 'anticipatedPostingDate': '2025-12'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival by KRAS Variant Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '470', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Variant', 'description': 'Has the KRAS variant'}, {'id': 'OG001', 'title': 'Non-variant', 'description': 'Does not have the KRAS variant'}], 'classes': [{'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000', 'lowerLimit': '62.6', 'upperLimit': '81.3'}, {'value': '71.5', 'groupId': 'OG001', 'lowerLimit': '67.3', 'upperLimit': '75.7'}]}]}], 'analyses': [{'pValue': '0.3704', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.38', 'pValueComment': 'One-sided significance level = 0.05.', 'estimateComment': 'Reference level = non-variant', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by treatment arm.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.', 'description': 'KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments.\n\nAn event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants with KRAS data', 'anticipatedPostingDate': '2025-12'}, {'type': 'SECONDARY', 'title': 'Overall Survival by Treatment Arm Within KRAS Variant Status Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'title': 'Variant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '72.0', 'upperLimit': '94.6'}, {'value': '78.4', 'groupId': 'OG001', 'lowerLimit': '66.5', 'upperLimit': '90.3'}]}]}, {'title': 'Non-variant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000', 'lowerLimit': '75.6', 'upperLimit': '86.1'}, {'value': '77.6', 'groupId': 'OG001', 'lowerLimit': '72.2', 'upperLimit': '83.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.49', 'ciUpperLimit': '2.46', 'estimateComment': 'Reference level = IMRT + Cisplatin', 'groupDescription': 'Variant', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.53', 'estimateComment': 'Reference level = IMRT + Cisplatin', 'groupDescription': 'Non-variant', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9890', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided significance level = 0.05', 'groupDescription': 'Testing Cox proportional hazards model interaction term for KRAS variant status and treatment arm.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.', 'description': 'KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments.\n\nAn event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants with KRAS data'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival Within KRAS Variant Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'OG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'classes': [{'title': 'Variant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000', 'lowerLimit': '63.9', 'upperLimit': '89.3'}, {'value': '67.7', 'groupId': 'OG001', 'lowerLimit': '54.2', 'upperLimit': '81.2'}]}]}, {'title': 'Non-variant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.1', 'groupId': 'OG000', 'lowerLimit': '69.4', 'upperLimit': '80.8'}, {'value': '68.0', 'groupId': 'OG001', 'lowerLimit': '62.0', 'upperLimit': '74.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.50', 'ciUpperLimit': '2.04', 'estimateComment': 'Reference level = IMRT + Cisplatin', 'groupDescription': 'Variant', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.73', 'estimateComment': 'Reference level = IMRT + Cisplatin', 'groupDescription': 'Non-variant', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5556', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided significance level = 0.05', 'groupDescription': 'Testing Cox proportional hazards model interaction term for KRAS variant status and treatment arm.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.', 'description': 'KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments.\n\nAn event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants with KRAS data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'FG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '424'}, {'groupId': 'FG001', 'numSubjects': '425'}]}, {'type': 'Eligible', 'comment': 'All eligible participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '406'}, {'groupId': 'FG001', 'numSubjects': '399'}]}, {'type': 'Started treatment', 'comment': 'Eligible and started study treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '398'}, {'groupId': 'FG001', 'numSubjects': '394'}]}, {'type': 'AE assessed 1 month post-treatment (PT)', 'comment': 'Eligible, started study treatment, and had adverse events (AE) assessment 1 month post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '369'}, {'groupId': 'FG001', 'numSubjects': '363'}]}, {'type': 'AE assessed 3 months PT', 'comment': 'Eligible, started study treatment, and had adverse events assessment 3 months post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '359'}, {'groupId': 'FG001', 'numSubjects': '367'}]}, {'type': 'AE assessed 6 months PT', 'comment': 'Eligible, started study treatment, and had adverse events assessment 6 months post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '361'}, {'groupId': 'FG001', 'numSubjects': '352'}]}, {'type': 'AE assessment 1 year PT', 'comment': 'Eligible, started study treatment, and had adverse events assessment 1 year post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '360'}, {'groupId': 'FG001', 'numSubjects': '351'}]}, {'type': 'AE assessed 2 years PT', 'comment': 'Eligible, started study treatment, and had adverse events assessment 2 years post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '311'}, {'groupId': 'FG001', 'numSubjects': '303'}]}, {'type': 'AE assessed 5 years PT', 'comment': 'Eligible, started study treatment, and had adverse events assessment 5 years post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'Dental health assessed 1 year PT', 'comment': 'Eligible, started study treatment, and had dental health assessment 1 year post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '267'}, {'groupId': 'FG001', 'numSubjects': '267'}]}, {'type': 'Dental health assessed 2 years PT', 'comment': 'Eligible, started study treatment, and had dental health assessment 2 years post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '201'}]}, {'type': 'Dental health assessed 5 years PT', 'comment': 'Eligible, started study treatment, and had dental health assessment 5 years post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Feeding tube assessed', 'comment': 'Eligible, started study treatment, and had feeding tube assessment 1 year post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '368'}, {'groupId': 'FG001', 'numSubjects': '356'}]}, {'type': 'Progressed', 'comment': 'Eligible and experienced local, regional, or distant progression or death', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'comment': 'Subjects contributing any data to analysis are considered to have completed the study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '406'}, {'groupId': 'FG001', 'numSubjects': '399'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'HIV positive', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Sites were required to submit participant tumor tissue for central p16 evaluation within one week of registration. If participants were determined to be p16-positive and continued on the study, then treatment arm was assigned. Of 987 participants registered, 849 were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'BG000'}, {'value': '399', 'groupId': 'BG001'}, {'value': '805', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin\n\nCisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'BG001', 'title': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab\n\nCetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks\n\nIMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '63'}, {'value': '58', 'groupId': 'BG001', 'lowerLimit': '52', 'upperLimit': '63'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '52', 'upperLimit': '63'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '<= 65', 'categories': [{'measurements': [{'value': '344', 'groupId': 'BG000'}, {'value': '345', 'groupId': 'BG001'}, {'value': '689', 'groupId': 'BG002'}]}]}, {'title': '> 65', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '373', 'groupId': 'BG000'}, {'value': '355', 'groupId': 'BG001'}, {'value': '728', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '383', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '752', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '380', 'groupId': 'BG000'}, {'value': '367', 'groupId': 'BG001'}, {'value': '747', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Zubrod performance status', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '595', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measure Description: 0 - Asymptomatic; 1 - Symptomatic but completely ambulatory; 2 - Symptomatic, \\<50% in bed during the day; 3 - Symptomatic, \\>50% in bed, but not bedbound; 4 - Bedbound; 5 - Death', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking history', 'classes': [{'title': '0 pack-years', 'categories': [{'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}]}, {'title': '>0 to <= 10 pack-years', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}, {'title': '>10 pack-years', 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Smoking history as measured in pack-years. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking history', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '22'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '24'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '23'}]}]}], 'paramType': 'MEDIAN', 'description': 'Measure Description: Smoking history as measured in pack-years. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.', 'unitOfMeasure': 'pack-years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Primary site', 'classes': [{'title': 'Tonsillar fossa, tonsil', 'categories': [{'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}]}, {'title': 'Base of tongue', 'categories': [{'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '353', 'groupId': 'BG002'}]}]}, {'title': 'Oropharynx, not otherwise specified', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Pharyngeal oropharynx', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Soft palate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Vallecula', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Primary location of tumor', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor stage', 'classes': [{'title': 'T1', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}, {'title': 'T2', 'categories': [{'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}]}, {'title': 'T3', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}]}, {'title': 'T4', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Tumor stage per the American Joint Committee on Cancer (AJCC) 7th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues.', 'unitOfMeasure': 'Participants'}, {'title': 'Node category', 'classes': [{'title': 'N0', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'N1', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'N2a', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}, {'title': 'N2b', 'categories': [{'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '417', 'groupId': 'BG002'}]}]}, {'title': 'N2c', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}, {'title': 'N3', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 7th ed. refers to the number and/or extent of spread of lymph nodes that contain cancer. The higher the number after the N, the greater the involvement of regional lymph nodes.', 'unitOfMeasure': 'Participants'}, {'title': 'Overall stage', 'classes': [{'categories': [{'title': 'III', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'IV', 'measurements': [{'value': '377', 'groupId': 'BG000'}, {'value': '368', 'groupId': 'BG001'}, {'value': '745', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Overall cancer stage per American Joint Committee on Cancer (AJCC) 7th ed. combines tumor (T), regional lymph node (N), and distant metastasis (M) staging to determine an overall stage of 0, I, II, III, or IV, ranging from least to most advanced, respectively. Stage III: T3/N0/M0 or T1-3/N1/M0; Stage IV: T4/any N/M0 or any T/N2-3/M0.', 'unitOfMeasure': 'Participants'}, {'title': 'Risk group per study RTOG-0129', 'classes': [{'categories': [{'title': 'Low risk', 'measurements': [{'value': '289', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '573', 'groupId': 'BG002'}]}, {'title': 'Intermediate risk', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Risk group as defined by recursive partitioning analysis of study RTOG-0129 (NCT00047008). Low-risk consists of patients with p16-positive tumors and 10 or fewer pack-years or p16-positive, \\>10 pack-years, and N0-2a disease. Intermediate-risk consists of p16-positive, \\>10 pack-years, and N2b-3 disease or p16-negative, 10 or fewer pack-years, and T2-3 disease. High-risk consists of p16-negative, 10 or fewer pack-years, and T4 disease or p16-negative and \\>10 pack-years.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Eligible participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-23', 'size': 796975, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-25T17:08', 'hasProtocol': True}, {'date': '2016-02-23', 'size': 480999, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-11-25T17:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 987}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2011-02-22', 'resultsFirstSubmitDate': '2019-11-27', 'studyFirstSubmitQcDate': '2011-02-22', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2019-12-19', 'studyFirstPostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.', 'description': 'An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.', 'description': 'An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.'}, {'measure': 'Time to Local-regional Failure', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.', 'description': 'Failure for local-regional failure endpoint was defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \\> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and death due to other causes were considered competing risks. Local-regional failure time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of local-regional failure times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.'}, {'measure': 'Time to Distant Metastasis', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.', 'description': 'Failure for distant metastasis endpoint was defined as distant progression; local-regional failure and death due to any cause were considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of distant metastasis times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.'}, {'measure': 'Time to Secondary Primary Cancer', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.', 'description': 'Failure for second primary endpoint was defined as reporting of a new primary cancer; death due to any cause was considered a competing risk. Second primary time is defined as time from randomization to the date of second primary or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol endpoint is the distribution of second primary cancer times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.'}, {'measure': 'Distribution of First Progression Events', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.', 'description': 'The first event type for progression-free survival is counted for each participant. Possible first progression events are local, regional, or distant progression, any combination of these, or death. The frequency table of these events is also referred to as "Pattern of failure."'}, {'measure': 'Percentage of Participants Experiencing Early Death', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.', 'description': 'Early death is defined as death due to adverse event or within 30 days of treatment completion.'}, {'measure': 'Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: During Treatment', 'timeFrame': 'From start of treatment to end of treatment, approximately 6 weeks', 'description': 'Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE'}, {'measure': 'Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 1 Month After End of Study Treatment', 'timeFrame': 'From start of treatment to approximately 2.5 months (1 month after the end of treatment)', 'description': 'Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE'}, {'measure': 'Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 3 Months After the End of Study Treatment', 'timeFrame': 'From start of treatment to approximately 4.5 months (3 months after the end of treatment)', 'description': 'Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE'}, {'measure': 'Percentage of Participants With Acute Grade 3-4 Treatment-related Adverse Events: 6 Months After the End of Study Treatment', 'timeFrame': 'From start of treatment to approximately 7.5 months (6 months after the end of treatment)', 'description': 'Acute adverse events (AE) are defined as occurring within 180 days from the end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE'}, {'measure': 'Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 1 Year After the End of Study Treatment', 'timeFrame': 'From start of treatment to approximately 13.5 months (one year after the end of treatment)', 'description': 'Late adverse events (AE) are defined as \\> 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE'}, {'measure': 'Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 2 Years After the End of Study Treatment', 'timeFrame': 'From 180 days after end of treatment to two years after end of treatment.', 'description': 'Late adverse events (AE) are defined as \\> 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE'}, {'measure': 'Percentage of Participants With Late Grade 3-4 Treatment-related Adverse Events: 5 Years After the End of Study Treatment', 'timeFrame': 'From start of treatment to approximately 61.5 months (five years after the end of treatment)', 'description': 'Late adverse events (AE) are defined as \\> 180 days from end of treatment. "Treatment-related" means reported as definitely, probably, or possibly related to protocol treatment. AE were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE'}, {'measure': 'Percentage of Participants With a Feeding Tube at 1 Year', 'timeFrame': 'From randomization to 1 year.'}, {'measure': 'EORTC QLQ-C30 Global Health Status Score Change From Baseline at End of Treatment', 'timeFrame': 'Baseline and end of treatment (6-7 weeks)', 'description': "The EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement."}, {'measure': 'EORTC QLQ-C30 Global Health Status Score Change From Baseline at 3 Months From End of Treatment', 'timeFrame': 'Baseline and 3 months from end of treatment. Treatment lasts 6-7 weeks.', 'description': "The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement."}, {'measure': 'EORTC QLQ-C30 Global Health Status Score Change From Baseline at 6 Months From End of Treatment', 'timeFrame': 'Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.', 'description': "The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement."}, {'measure': 'EORTC QLQ-C30 Global Health Status Score Change From Baseline at 12 Months From End of Treatment', 'timeFrame': 'Baseline and 12 months from end of treatment. Treatment lasts 6-7 weeks', 'description': "The EORTC QLQ-C30 Global Health Status score measures a cancer patient's perception of their overall health and well-being and ranges from 0 (worst) to 100 (best). A positive change from baseline indicates improvement."}, {'measure': 'EORTC QLQ-H&N35 Swallowing Score Change From Baseline at End of Treatment', 'timeFrame': 'Baseline and end of treatment (6-7 weeks)', 'description': 'The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer Module (EORTC QLQ-H\\&N35) swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.'}, {'measure': 'EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 3 Months From End of Treatment.', 'timeFrame': 'Baseline and 3 months from end of treatment. Treatment lasts 6-7 weeks.', 'description': 'The EORTC QLQ-H\\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.'}, {'measure': 'EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 6 Months From End of Treatment.', 'timeFrame': 'Baseline and 6 months from end of treatment. Treatment lasts 6-7 weeks.', 'description': 'The EORTC QLQ-H\\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.'}, {'measure': 'EORTC QLQ-H&N35 Swallowing Score Change From Baseline at 12 Months From End of Treatment.', 'timeFrame': 'Baseline and 12 months from end of treatment. Treatment lasts 6-7 weeks.', 'description': 'The EORTC QLQ-H\\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.'}, {'measure': 'Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Head and Neck (PRO-CTCAE H&N) at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.', 'timeFrame': 'From randomization to 1 year after end of treatment.'}, {'measure': 'EuroQol Five Dimension Scale (EQ-5D) at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.', 'timeFrame': 'From randomization to 1 year after end of treatment.'}, {'measure': 'Work Status Questionnaire at Baseline, End of Treatment, 3, 6, and 12 Months.', 'timeFrame': 'From randomization to 1 year after end of treatment.'}, {'measure': 'Percentage of Patients With Normal/Good Dental Health: Pretreatment', 'timeFrame': 'Before treatment', 'description': 'This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease";\n\n1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \\< 5 restorations indicated; no extractions indicated." Ten year data is not yet available.'}, {'measure': 'Percentage of Patients With Normal/Good Dental Health: 1 Year After End of Treatment', 'timeFrame': '1 year after end of treatment (approximately 13.5 months)', 'description': 'This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease";\n\n1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \\< 5 restorations indicated; no extractions indicated."'}, {'measure': 'Percentage of Patients With Normal/Good Dental Health: 2 Years After End of Treatment', 'timeFrame': '2 years after end of treatment (approximately 25.5 months)', 'description': 'This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \\< 5 restorations indicated; no extractions indicated."'}, {'measure': 'Percentage of Patients With Normal/Good Dental Health: 5 Years After End of Treatment', 'timeFrame': '5 years after end of treatment (approximately 61.5 months)', 'description': 'This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \\< 5 restorations indicated; no extractions indicated."'}, {'measure': 'Percentage of Patients With Normal/Good Dental Health: 10 Years After End of Treatment', 'timeFrame': '10 years after end of treatment (approximately 121.5 months)', 'description': 'This study utilized a dental effects health scale from 0 (normal) to 4 (life-threatening dental condition). The percentage of participants with a value of 0 or 1 is reported: 0 = "Normal: Edentulous, with no gingival disease"; 1 = "Mild changes/good dental health: mild periodontal inflammation-routine cleaning indicated; \\< 5 restorations indicated; no extractions indicated."'}, {'measure': 'Number of Participants by HHIA-S Category at Baseline', 'timeFrame': 'Baseline', 'description': "The Hearing Handicap Inventory for Adults Screen Version (HHIA-S) measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:\n\n* No handicap: 0-8.\n* Mild-moderate handicap: 10-24.\n* Severe handicap: 26-40."}, {'measure': 'Number of Participants by HHIA-S Category at End of Treatment', 'timeFrame': 'End of treatment (6-7 weeks)', 'description': "The Hearing Handicap Inventory for Adults Screen Version (HHIA-S) measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:\n\n* No handicap: 0-8.\n* Mild-moderate handicap: 10-24.\n* Severe handicap: 26-40."}, {'measure': 'Number of Participants by HHIA-S Category at 3 Months After End of Treatment', 'timeFrame': '3 months after end of treatment. Treatment lasts 6-7 weeks.', 'description': "The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:\n\n* No handicap: 0-8.\n* Mild-moderate handicap: 10-24.\n* Severe handicap: 26-40."}, {'measure': 'Number of Participants by HHIA-S Category at 6 Months After End of Treatment', 'timeFrame': '6 months after end of treatment. Treatment lasts 6-7 weeks.', 'description': "The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:\n\n* No handicap: 0-8.\n* Mild-moderate handicap: 10-24.\n* Severe handicap: 26-40."}, {'measure': 'Number of Participants by HHIA-S Category at 12 Months After End of Treatment', 'timeFrame': '12 months after end of treatment. Treatment lasts 6-7 weeks.', 'description': "The HHIA-S measures a person's perceived hearing handicap. Total score ranges from 0 to 40, with a higher score indicating more severe perceived hearing handicap, categorized as follows:\n\n* No handicap: 0-8.\n* Mild-moderate handicap: 10-24.\n* Severe handicap: 26-40."}, {'measure': 'Overall Survival by KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) Variant Status', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.', 'description': 'KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments.\n\nAn event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.'}, {'measure': 'Progression-free Survival by KRAS Variant Status', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.', 'description': 'KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments.\n\nAn event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.'}, {'measure': 'Overall Survival by Treatment Arm Within KRAS Variant Status Group', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.', 'description': 'KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments.\n\nAn event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.'}, {'measure': 'Progression-free Survival Within KRAS Variant Status', 'timeFrame': 'From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 214 deaths were reported. Median follow-up at time of analysis was 8.3 years.', 'description': 'KRAS (Kirsten Rat Sarcoma Viral Oncogene Homolog) is a gene that helps control how cells grow. Some people have a change in this gene, which can be detected (variant/non-variant) by a genetic test performed on tissue from their tumor. Research suggests that this change may influence how head and neck cancer responds to certain treatments.\n\nAn event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is the distribution of progression-free survival times, for which the hazard ratio is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage III squamous cell carcinoma of the oropharynx', 'stage IV squamous cell carcinoma of the oropharynx', 'human papilloma virus infection'], 'conditions': ['Head and Neck Cancer', 'Precancerous Condition']}, 'referencesModule': {'availIpds': [{'id': 'NCT01302834', 'url': 'https://nctn-data-archive.nci.nih.gov/', 'type': 'Individual Participant Data Set', 'comment': 'Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive'}], 'references': [{'pmid': '30449625', 'type': 'RESULT', 'citation': 'Gillison ML, Trotti AM, Harris J, Eisbruch A, Harari PM, Adelstein DJ, Jordan RCK, Zhao W, Sturgis EM, Burtness B, Ridge JA, Ringash J, Galvin J, Yao M, Koyfman SA, Blakaj DM, Razaq MA, Colevas AD, Beitler JJ, Jones CU, Dunlap NE, Seaward SA, Spencer S, Galloway TJ, Phan J, Dignam JJ, Le QT. Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial. Lancet. 2019 Jan 5;393(10166):40-50. doi: 10.1016/S0140-6736(18)32779-X. Epub 2018 Nov 15.'}, {'pmid': '41343184', 'type': 'DERIVED', 'citation': 'Gharzai LA, Morris E, Schipper MJ, Kidwell KM, Nguyen-Tan PF, Rosenthal DI, Gillison ML, Jordan RC, Garden AS, Koyfman SA, Caudell JJ, Blakaj DM, Dunlap NE, Krempl GA, Longo JM, Jones CU, Gensheimer MF, Galloway TJ, DeMora L, Le QT, Shah JL, Suresh K, Mierzwa M. Treatment Interruption and Outcomes in Head and Neck Cancer: A Secondary Analysis of 3 Randomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2025 Dec 4. doi: 10.1001/jamaoto.2025.4203. Online ahead of print.'}, {'pmid': '36401615', 'type': 'DERIVED', 'citation': 'Quan DL, Grauer JS, Sunkara PR, Cramer JD. Surgical salvage of human papillomavirus-positive oropharyngeal cancer: Secondary analysis of a randomized controlled trial. Cancer. 2023 Feb 1;129(3):376-384. doi: 10.1002/cncr.34562. Epub 2022 Nov 19.'}, {'pmid': '25057165', 'type': 'DERIVED', 'citation': 'Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer.\n\nPURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival.\n\nSecondary\n\n* To monitor and compare progression-free survival for "safety".\n* To compare patterns of failure (locoregional vs distant).\n* To compare acute toxicity profiles (and overall toxicity burden).\n* To compare overall quality of life (QOL) short-term (\\< 6 months) and long-term (1 year).\n* To compare QOL Swallowing Domains short-term and long-term.\n* To compare clinician-reported versus patient-reported CTCAE toxicity events.\n* To explore differences in the cost effectiveness of cetuximab as compared to cisplatin.\n* To explore differences in work status and time to return to work.\n* To compare patient-reported changes in hearing.\n* To compare CTCAE v. 4 late toxicity at 1, 2, and 5 years.\n* To evaluate the effect of tobacco exposure (and other exposures) as measured by standardized computer-assisted self interview (CASI) on overall survival and progression-free survival.\n* To pilot CASI collection of patient reported outcomes in a cooperative group setting.\n* To determine whether specific molecular profiles are associated with overall or progression-free survival.\n* To investigate associations between changes in serum biomarkers or human papilloma virus (HPV)-specific cellular immune responses measured at baseline and three months with overall or progression-free survival.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to T stage (T1-2 vs T 3-4), N stage (N0-2a vs N2b-3), Zubrod performance status (0 vs 1), and smoking history (≤ 10 pack-years vs \\> 10 pack-years). Patients are randomized to 1 of 2 treatment arms.\n\nPatients may complete quality-of-life questionnaires and risk factors for head and neck cancer surveys at baseline, periodically during study, and at follow-up for 1 year.\n\nAfter completion of study therapy, patients are followed up at 1-3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls).\n2. Patients must be positive for p16, determined by central review prior to randomization.\n3. Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions. Fine needle aspirations of the neck are insufficient due to limited tissue for retrospective central review. Biopsy specimens from the primary or nodes measuring at least 3-5 mm are required.\n4. Clinical stage T1-2, N2a-N3 or T3-4, any N (AJCC, 7th ed.; see Appendix III), including no distant metastases, based upon the following minimum diagnostic workup:\n\n * General history and physical examination by a radiation oncologist and medical oncologist within 8 weeks prior to registration;\n * Examination by an ear, nose, and throat (ENT) or head and neck surgeon, including laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 8 weeks prior to registration;\n * One of the following combinations of imaging is required within 8 weeks prior to registration:\n\n 1. A computerized tomography (CT) scan of the neck (with contrast) and a chest CT scan (with or without contrast);\n 2. or a magnetic resonance imaging (MRI) scan of the neck (with contrast) and a chest CT scan (with or without contrast);\n 3. or a CT scan of neck (with contrast) and a positron emission tomography (PET)/CT of neck and chest (with or without contrast);\n 4. or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast).\n\n Note: A CT scan of neck and/or a PET/CT performed for radiation planning and read by a radiologist may serve as both staging and planning tools.\n5. Zubrod Performance Status 0-1 within 2 weeks prior to registration\n6. Age ≥ 18;\n7. Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function, defined as follows:\n\n * Absolute neutrophil count (ANC) \\> 1,500 cells/mm3;\n * Platelets \\> 100,000 cells/mm3;\n * Hemoglobin (Hgb) \\> 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb \\> 8.0 g/dl is acceptable.\n8. Adequate hepatic function, defined as follows:\n\n * Bilirubin \\< 2 mg/dl within 2 weeks prior to registration;\n * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\< 3 x the upper limit of normal within 2 weeks prior to registration;\n9. Adequate renal function, defined as follows:\n\n • Serum creatinine \\< 1.5 mg/dl within 2 weeks prior to registration or creatinine clearance (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula:\n\n CCr male = \\[(140 - age) x (wt in kg)\\] \\[(Serum Cr mg/dl) x (72)\\] CCr female = 0.85 x (CCr male)\n10. Patients must provide their smoking history (for stratification) via the computer-assisted self interview (CASI) head and neck risk factor survey tool.\n11. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential;\n12. Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study and until at least 60 days following the last study treatment.\n13. Patients who are human immunodeficiency virus (HIV) positive but have no prior acquired immune deficiency syndrome (AIDS) -defining illness and have CD4 cells of at least 350/mm3 are eligible. Patient HIV status must be known prior to registration. Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C antibody positive). However, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B). HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions.\n14. Patient must provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required, central p16 review and consent to participate in the computer-assisted self interview (CASI) survey questions regarding smoking history.\n\nExclusion Criteria:\n\n1. Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx, even if p16 positive, are excluded. Carcinoma of the neck of unknown primary site origin (even if p16 positive) are excluded from participation.\n2. Stage T1-2, N0-1;\n3. Distant metastasis or adenopathy below the clavicles;\n4. Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease.\n5. Simultaneous primaries or bilateral tumors;\n6. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);\n7. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;\n8. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;\n9. Severe, active co-morbidity, defined as follows:\n\n * 9.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;\n * 9.2 Transmural myocardial infarction within the last 6 months;\n * 9.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;\n * 9.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;\n * 9.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.\n * 9.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition with immune compromise greater than that noted in Section 3.1.13; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.\n10. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.\n11. Prior allergic reaction to cisplatin or cetuximab;\n12. Prior cetuximab or other anti-EGFR therapy.'}, 'identificationModule': {'nctId': 'NCT01302834', 'briefTitle': 'Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Radiation Therapy Oncology Group'}, 'officialTitle': 'Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer', 'orgStudyIdInfo': {'id': 'RTOG-1016'}, 'secondaryIdInfos': [{'id': 'CDR0000695731'}, {'id': 'NCI-2011-02638', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IMRT + Cisplatin', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin', 'interventionNames': ['Drug: cisplatin', 'Radiation: IMRT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IMRT + Cetuximab', 'description': 'Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab', 'interventionNames': ['Biological: cetuximab', 'Radiation: IMRT']}], 'interventions': [{'name': 'cetuximab', 'type': 'BIOLOGICAL', 'description': '400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks', 'armGroupLabels': ['IMRT + Cetuximab']}, {'name': 'cisplatin', 'type': 'DRUG', 'description': '100 mg/m2 IV on days 1 and 22 of IMRT', 'armGroupLabels': ['IMRT + Cisplatin']}, {'name': 'IMRT', 'type': 'RADIATION', 'otherNames': ['intensity-modulated radiotherapy', 'intensity-modulated radiation therapy'], 'description': '35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.', 'armGroupLabels': ['IMRT + Cetuximab', 'IMRT + Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Providence Cancer Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '95603', 'city': 'Auburn', 'state': 'California', 'country': 'United States', 'facility': 'Auburn Radiation Oncology', 'geoPoint': {'lat': 38.89657, 'lon': -121.07689}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '95682', 'city': 'Cameron Park', 'state': 'California', 'country': 'United States', 'facility': 'Radiation Oncology Centers - Cameron Park', 'geoPoint': {'lat': 38.66879, 'lon': -120.98716}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Mercy Cancer Center at Mercy San Juan Medical Center', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '95926', 'city': 'Chico', 'state': 'California', 'country': 'United States', 'facility': 'Enloe Cancer Center at Enloe Medical Center', 'geoPoint': {'lat': 39.72849, 'lon': -121.83748}}, {'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92093-0658', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Rebecca and John Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente - Division of Research - Oakland', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94928', 'city': 'Rohnert Park', 'state': 'California', 'country': 'United States', 'facility': 'Rohnert Park Cancer Center', 'geoPoint': {'lat': 38.33964, 'lon': -122.7011}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Radiation Oncology Center - Roseville', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Radiological Associates of Sacramento Medical Group, Incorporated', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Mercy General Hospital', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95051', 'city': 'Santa Clara', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}, {'zip': '94080', 'city': 'South San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center - South San Francisco', 'geoPoint': {'lat': 37.65466, 'lon': -122.40775}}, {'zip': '95687', 'city': 'Vacaville', 'state': 'California', 'country': 'United States', 'facility': 'Solano Radiation Oncology Center', 'geoPoint': {'lat': 38.35658, 'lon': -121.98774}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers - Aurora', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80301-9019', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Community Hospital', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80933', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Penrose Cancer Center at Penrose Hospital', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Porter Adventist Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80110', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '80539', 'city': 'Loveland', 'state': 'Colorado', 'country': 'United States', 'facility': 'McKee Medical Center', 'geoPoint': {'lat': 40.39776, 'lon': -105.07498}}, {'zip': '80229', 'city': 'Thornton', 'state': 'Colorado', 'country': 'United States', 'facility': 'North Suburban Medical Center', 'geoPoint': {'lat': 39.86804, 'lon': -104.97192}}, {'zip': '06050', 'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'CCOP - Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '33064-3596', 'city': 'Dearfield Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'North Broward Medical Center'}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Cancer Institute - Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Integrated Community Oncology Network at Southside Cancer Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32250', 'city': 'Jacksonville Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Integrated Community Oncology Network', 'geoPoint': {'lat': 30.29469, 'lon': -81.39314}}, {'zip': '32258', 'city': 'Jascksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Medical Center South'}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Sylvester Comprehensive Cancer Center - Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32073', 'city': 'Orange Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Integrated Community Oncology Network - Orange Park', 'geoPoint': {'lat': 30.16607, 'lon': -81.70648}}, {'zip': '32803-1273', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Cancer Institute at Florida Hospital Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center at Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32177', 'city': 'Palatka', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Center - Palatka', 'geoPoint': {'lat': 29.64858, 'lon': -81.63758}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Sacred Heart Cancer Center at Sacred Heart Hospital', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '32086', 'city': 'Saint Augustine', 'state': 'Florida', 'country': 'United States', 'facility': 'Flagler Cancer Center', 'geoPoint': {'lat': 29.89469, 'lon': -81.31452}}, {'zip': '33612-9497', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute at University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Cancer Center for Excellence at Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northeast Georgia Medical Center', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '31403-3089', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': "Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler", 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwest Community Hospital', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '60611-3013', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center at Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612-3785', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'John H. Stroger, Jr. Hospital of Cook County', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Creticos Cancer Center at Advocate Illinois Masonic Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'Decatur Memorial Hospital Cancer Care Institute', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '60201-1781', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Hospital', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cardinal Bernardin Cancer Center at Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': "Cancer Institute at St. John's Hospital", 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '62781-0001', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Regional Cancer Center at Memorial Medical Center', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46107', 'city': 'Beech Grove', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Francis Hospital and Health Centers - Beech Grove Campus', 'geoPoint': {'lat': 39.72199, 'lon': -86.08998}}, {'zip': '46515', 'city': 'Elkhart', 'state': 'Indiana', 'country': 'United States', 'facility': 'Elkhart General Hospital', 'geoPoint': {'lat': 41.68199, 'lon': -85.97667}}, {'zip': '46805', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Parkview Regional Cancer Center at Parkview Health', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46526', 'city': 'Goshen', 'state': 'Indiana', 'country': 'United States', 'facility': 'Center for Cancer Care at Goshen General Hospital', 'geoPoint': {'lat': 41.58227, 'lon': -85.83444}}, {'zip': '46219', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Regional Cancer Care at Community Hospital East', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Regional Cancer Care at Community Hospital North', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46545-1470', 'city': 'Mishawaka', 'state': 'Indiana', 'country': 'United States', 'facility': 'Michiana Hematology-Oncology, PC - South Bend', 'geoPoint': {'lat': 41.66199, 'lon': -86.15862}}, {'zip': '47303-3499', 'city': 'Muncie', 'state': 'Indiana', 'country': 'United States', 'facility': 'Cancer Center at Ball Memorial Hospital', 'geoPoint': {'lat': 40.19338, 'lon': -85.38636}}, {'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'Memorial Hospital of South Bend', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '50010', 'city': 'Ames', 'state': 'Iowa', 'country': 'United States', 'facility': 'McFarland Clinic, PC', 'geoPoint': {'lat': 42.03471, 'lon': -93.61994}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'John Stoddard Cancer Center at Iowa Methodist Medical Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Hematology-Oncology Associates, LLP', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '66160-7357', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas City Cancer Centers - Southwest', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66208', 'city': 'Prairie Village', 'state': 'Kansas', 'country': 'United States', 'facility': 'CCOP - Kansas City', 'geoPoint': {'lat': 38.99167, 'lon': -94.63357}}, {'zip': '40536-0093', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Lucille P. Markey Cancer Center at University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'James Graham Brown Cancer Center at University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Mary Bird Perkins Cancer Center - Baton Rouge', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'CCOP - Ochsner', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Center for Cancer Medicine and Blood Disorders - Scarborough', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Greenebaum Cancer Center at University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21229', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'St. Agnes Hospital Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic Medical Center - Burlington', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '01923', 'city': 'Danvers', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'NSMC Cancer Center - Peabody', 'geoPoint': {'lat': 42.57509, 'lon': -70.93005}}, {'zip': '02721', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Hudner Oncology Center at Saint Anne's Hospital - Fall River", 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '48106-0995', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saint Joseph Mercy Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49017', 'city': 'Battle Creek', 'state': 'Michigan', 'country': 'United States', 'facility': 'Battle Creek Health System Cancer Care Center', 'geoPoint': {'lat': 42.3173, 'lon': -85.17816}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Josephine Ford Cancer Center at Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48503', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Genesys Hurley Cancer Institute', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Butterworth Hospital at Spectrum Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': "Lacks Cancer Center at Saint Mary's Health Care", 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55433', 'city': 'Coon Rapids', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mercy and Unity Cancer Center at Mercy Hospital', 'geoPoint': {'lat': 45.11997, 'lon': -93.28773}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview Southdale Hospital', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mercy and Unity Cancer Center at Unity Hospital', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Park Nicollet Cancer Center', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Regions Hospital Cancer Care Center', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '39581', 'city': 'Pascagoula', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Regional Cancer Center at Singing River Hospital', 'geoPoint': {'lat': 30.36576, 'lon': -88.55613}}, {'zip': '63703', 'city': 'Cape Girardeau', 'state': 'Missouri', 'country': 'United States', 'facility': 'Cancer Institute of Cape Girardeau, LLC', 'geoPoint': {'lat': 37.30588, 'lon': -89.51815}}, {'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City Cancer Centers - South', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64154', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City Cancer Centers - North', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Hulston Cancer Center at Cox Medical Center South', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes-Jewish West County Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'CCOP - St. Louis-Cape Girardeau', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "David C. Pratt Cancer Center at St. John's Mercy", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59107-7000', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Billings Clinic - Downtown', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Methodist Estabrook Cancer Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Renown Institute for Cancer at Renown Regional Medical Center', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '03301', 'city': 'Concord', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Payson Center for Cancer Care at Concord Hospital', 'geoPoint': {'lat': 43.20814, 'lon': -71.53757}}, {'zip': '03820', 'city': 'Dover', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Seacoast Cancer Center at Wentworth - Douglass Hospital', 'geoPoint': {'lat': 43.19786, 'lon': -70.87367}}, {'zip': '03431', 'city': 'Keene', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Kingsbury Center for Cancer Care at Cheshire Medical Center', 'geoPoint': {'lat': 42.93369, 'lon': -72.27814}}, {'zip': '03756-0002', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '07740-6395', 'city': 'Long Branch', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Monmouth Medical Center', 'geoPoint': {'lat': 40.30428, 'lon': -73.99236}}, {'zip': '07871', 'city': 'Sparta', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Frederick R. and Betty M. Smith Cancer Treatment Center', 'geoPoint': {'lat': 41.03343, 'lon': -74.63849}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cancer Institute of New Jersey at Cooper - Voorhees', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '87131-5636', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Cancer Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '13905', 'city': 'Binghamton', 'state': 'New York', 'country': 'United States', 'facility': 'Lourdes Regional Cancer Center', 'geoPoint': {'lat': 42.09869, 'lon': -75.91797}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Highland Hospital of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'James P. Wilmot Cancer Center at University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Hospitals - Memorial Campus', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '28232-2861', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Blumenthal Cancer Center at Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27403-1198', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Moses Cone Regional Cancer Center at Wesley Long Community Hospital', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '28501', 'city': 'Kinston', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Kinston Medical Specialists', 'geoPoint': {'lat': 35.26266, 'lon': -77.58164}}, {'zip': '28374', 'city': 'Pinehurst', 'state': 'North Carolina', 'country': 'United States', 'facility': 'FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center', 'geoPoint': {'lat': 35.19543, 'lon': -79.46948}}, {'zip': '44309-2090', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Summa Center for Cancer Care at Akron City Hospital', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '44203', 'city': 'Barberton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Barberton Citizens Hospital', 'geoPoint': {'lat': 41.01283, 'lon': -81.60512}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Charles M. Barrett Cancer Center at University Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44111', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Cancer Center at Fairview Hospital', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210-1240', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43537-1839', 'city': 'Maumee', 'state': 'Ohio', 'country': 'United States', 'facility': 'Northwest Ohio Oncology Center', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '44124', 'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hillcrest Cancer Center at Hillcrest Hospital', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lake/University Ireland Cancer Center', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Southwest General Health Center', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '43616', 'city': 'Oregon', 'state': 'Ohio', 'country': 'United States', 'facility': 'St. Charles Mercy Hospital', 'geoPoint': {'lat': 41.64366, 'lon': -83.48688}}, {'zip': '43560', 'city': 'Sylvania', 'state': 'Ohio', 'country': 'United States', 'facility': 'Flower Hospital Cancer Center', 'geoPoint': {'lat': 41.71894, 'lon': -83.71299}}, {'zip': '43623', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'St. Anne Mercy Hospital', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '45069', 'city': 'West Chester', 'state': 'Ohio', 'country': 'United States', 'facility': 'Precision Radiotherapy at University Pointe', 'geoPoint': {'lat': 39.33172, 'lon': -84.40716}}, {'zip': '44145', 'city': 'Westlake', 'state': 'Ohio', 'country': 'United States', 'facility': 'UHHS Westlake Medical Center', 'geoPoint': {'lat': 41.45532, 'lon': -81.91792}}, {'zip': '44691', 'city': 'Wooster', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cancer Treatment Center', 'geoPoint': {'lat': 40.80517, 'lon': -81.93646}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma University Cancer Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Natalie Warren Bryant Cancer Center at St. Francis Hospital', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97015', 'city': 'Clackamas', 'state': 'Oregon', 'country': 'United States', 'facility': 'Clackamas Radiation Oncology Center', 'geoPoint': {'lat': 45.40762, 'lon': -122.57037}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Dubs Cancer Center at Rogue Valley Medical Center', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Cancer Center at PMCC', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '97213-2967', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Cancer Center at Providence Portland Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence St. Vincent Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239-3098', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Knight Cancer Institute at Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rosenfeld Cancer Center at Abington Memorial Hospital', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '18301', 'city': 'East Stroudsburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Dale and Frances Hughes Cancer Center at Pocono Medical Center', 'geoPoint': {'lat': 40.99954, 'lon': -75.18129}}, {'zip': '17325', 'city': 'Gettysburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Adams Cancer Center', 'geoPoint': {'lat': 39.83093, 'lon': -77.2311}}, {'zip': '17331', 'city': 'Hanover', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Cherry Tree Cancer Center', 'geoPoint': {'lat': 39.80066, 'lon': -76.98304}}, {'zip': '19047', 'city': 'Langhorne', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'St. Mary Regional Cancer Center', 'geoPoint': {'lat': 40.17455, 'lon': -74.92267}}, {'zip': '19111-2497', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center - Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19612-6052', 'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}, {'zip': '17405', 'city': 'York', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'York Cancer Center at Apple Hill Medical Center', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Hollings Cancer Center at Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Cancer Centers of the Carolinas - Faris Road', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CCOP - Greenville', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Gibbs Regional Cancer Center at Spartanburg Regional Medical Center', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '29307', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Cancer Centers of the Carolinas - Spartanburg', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Rapid City Regional Hospital', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '37232-6838', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77555-0361', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M. D. Anderson Cancer Center at University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84157', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Jon and Karen Huntsman Cancer Center at Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '84403', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'Val and Ann Browning Cancer Center at McKay-Dee Hospital Center', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '84604', 'city': 'Provo', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Valley Regional Medical Center - Provo', 'geoPoint': {'lat': 40.23384, 'lon': -111.65853}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Cancer Specialists at UCS Cancer Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute at University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Cancer Institute at Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23454', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Coastal Cancer Center at Sentara Virginia Beach General Hospital', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '98225', 'city': 'Bellingham', 'state': 'Washington', 'country': 'United States', 'facility': 'St. Joseph Cancer Center', 'geoPoint': {'lat': 48.75955, 'lon': -122.48822}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'CCOP - Virginia Mason Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98684', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Cancer Specialists at Vancouver Cancer Center', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}, {'zip': '98902', 'city': 'Yakima', 'state': 'Washington', 'country': 'United States', 'facility': 'North Star Lodge Cancer Center at Yakima Valley Memorial Hospital', 'geoPoint': {'lat': 46.60207, 'lon': -120.5059}}, {'zip': '25701', 'city': 'Huntington', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Edwards Comprehensive Cancer Center at Cabell Huntington Hospital', 'geoPoint': {'lat': 38.41925, 'lon': -82.44515}}, {'zip': '26003', 'city': 'Wheeling', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Schiffler Cancer Center at Wheeling Hospital', 'geoPoint': {'lat': 40.06396, 'lon': -80.72091}}, {'zip': '54911', 'city': 'Appleton', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Theda Care Cancer Institute', 'geoPoint': {'lat': 44.26193, 'lon': -88.41538}}, {'zip': '54303', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': "St. Mary's Hospital Medical Center - Green Bay", 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '54307-3508', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'St. Vincent Hospital Regional Cancer Center', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '54601', 'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Gundersen Lutheran Center for Cancer and Blood', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}, {'zip': '53792-6164', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Paul P. Carbone Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '54143', 'city': 'Marinette', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Bay Area Cancer Care Center at Bay Area Medical Center', 'geoPoint': {'lat': 45.09998, 'lon': -87.63066}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin Cancer Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53295', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Milwaukee', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '54401', 'city': 'Wausau', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconcin Cancer Center at Aspirus Wausau Hospital', 'geoPoint': {'lat': 44.95914, 'lon': -89.63012}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill Cancer Centre at McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Andy M. Trotti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H. Lee Moffitt Cancer Center and Research Institute'}, {'name': 'Maura Gillison, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radiation Therapy Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'NRG Oncology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}