{"description":"Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":11,"description":"PREOPERATIVE:Patients receive cisplatin IV over 2 hours 3 times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2.\n\nSURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3.\n\nINTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation.\n\nPOSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10.\n\nCisplatin: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1.\n\nPaclitaxel: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nod","id":"EG000","otherNumAffected":11,"otherNumAtRisk":11,"seriousNumAffected":11,"seriousNumAtRisk":11,"title":"Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":11,"numEvents":6}],"term":"Extremity pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11,"numEvents":4}],"term":"Edema-limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":11,"numEvents":10}],"term":"Oral cavity pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11,"numEvents":4}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11,"numEvents":4}],"term":"Salivary gland changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"oral cavity","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":11,"numEvents":10}],"term":"Mucositis/stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11,"numEvents":4}],"term":"Pulmonary/upper respiratory"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":11,"numEvents":6}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":3}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":11,"numEvents":10}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":11,"numEvents":10}],"term":"Dry mouth/salivary gland (xerostomia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":11,"numEvents":5}],"term":"Neutrophils/granulocytes/ANC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":3}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":11,"numEvents":8}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11,"numEvents":4}],"term":"Throat/pharynx, larynx pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":11,"numEvents":5}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":11,"numEvents":5}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11,"numEvents":4}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":11,"numEvents":8}],"term":"Leukocytes (total WBC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11,"numEvents":4}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"sensory","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":11,"numEvents":7}],"term":"Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":11,"numEvents":9}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":11,"numEvents":8}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11,"numEvents":4}],"term":"ALT (serum glutamic pyruvic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":11,"numEvents":9}],"term":"Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":11,"numEvents":9}],"term":"Dysphagia (difficulty swallowing)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11,"numEvents":4}],"term":"Face pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":11,"numEvents":9}],"term":"Edema-head and neck"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":11,"numEvents":7}],"term":"Infection"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Leukocytes (total WBC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Rash: dermatitis associated with radiation - Chemoradiation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils - Neck NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Edema: limb"}]}