{"description":"Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.","eventGroups":[{"deathsNumAffected":43,"deathsNumAtRisk":160,"description":"Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.\n\ncisplatin: Given IV\n\n3-dimensional conformal radiation therapy: Patients undergo radiotherapy\n\nintensity-modulated radiation therapy: Patients undergo radiotherapy","id":"EG000","otherNumAffected":156,"otherNumAtRisk":156,"seriousNumAffected":0,"seriousNumAtRisk":156,"title":"Cisplatin"},{"deathsNumAffected":32,"deathsNumAtRisk":160,"description":"Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.\n\npanitumumab: Given IV\n\n3-dimensional conformal radiation therapy: Patients undergo radiotherapy\n\naccelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy\n\nintensity-modulated radiation therapy: Patients undergo radiotherapy","id":"EG001","otherNumAffected":159,"otherNumAtRisk":159,"seriousNumAffected":0,"seriousNumAtRisk":159,"title":"Panitumumab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":156},{"groupId":"EG001","numAffected":5,"numAtRisk":159}],"term":"Hearing (monitoring program)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":156},{"groupId":"EG001","numAffected":20,"numAtRisk":159}],"term":"Hearing (without monitoring program)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":156},{"groupId":"EG001","numAffected":8,"numAtRisk":159}],"term":"Pain External ear"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":156},{"groupId":"EG001","numAffected":29,"numAtRisk":159}],"term":"Pain Middle ear"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":98,"numAtRisk":156},{"groupId":"EG001","numAffected":18,"numAtRisk":159}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":156},{"groupId":"EG001","numAffected":22,"numAtRisk":159}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":156},{"groupId":"EG001","numAffected":10,"numAtRisk":159}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":156},{"groupId":"EG001","numAffected":10,"numAtRisk":159}],"term":"Chelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":123,"numAtRisk":156},{"groupId":"EG001","numAffected":113,"numAtRisk":159}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":156},{"groupId":"EG001","numAffected":40,"numAtRisk":159}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":141,"numAtRisk":156},{"groupId":"EG001","numAffected":146,"numAtRisk":159}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":144,"numAtRisk":156},{"groupId":"EG001","numAffected":150,"numAtRisk":159}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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cavity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":136,"numAtRisk":156},{"groupId":"EG001","numAffected":94,"numAtRisk":159}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":156},{"groupId":"EG001","numAffected":12,"numAtRisk":159}],"term":"Pain Abdomen NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":156},{"groupId":"EG001","numAffected":45,"numAtRisk":159}],"term":"Pain Oral cavity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":156},{"groupId":"EG001","numAffected":67,"numAtRisk":159}],"term":"Salivary gland changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":156},{"groupId":"EG001","numAffected":6,"numAtRisk":159}],"term":"Teeth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":87,"numAtRisk":156},{"groupId":"EG001","numAffected":63,"numAtRisk":159}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":156},{"groupId":"EG001","numAffected":67,"numAtRisk":159}],"term":"Edema: head and neck"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":156},{"groupId":"EG001","numAffected":6,"numAtRisk":159}],"term":"Edema: limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":124,"numAtRisk":156},{"groupId":"EG001","numAffected":123,"numAtRisk":159}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":156},{"groupId":"EG001","numAffected":17,"numAtRisk":159}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":156},{"groupId":"EG001","numAffected":29,"numAtRisk":159}],"term":"Pain - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":156},{"groupId":"EG001","numAffected":22,"numAtRisk":159}],"term":"Rigors/chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":156},{"groupId":"EG001","numAffected":39,"numAtRisk":159}],"term":"Infection - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":156},{"groupId":"EG001","numAffected":9,"numAtRisk":159}],"term":"Infection with normal ANC Catheter-related"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":64,"numAtRisk":156},{"groupId":"EG001","numAffected":80,"numAtRisk":159}],"term":"Dermatitis Chemoradiation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":94,"numAtRisk":156},{"groupId":"EG001","numAffected":72,"numAtRisk":159}],"term":"Dermatitis Radiation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":156},{"groupId":"EG001","numAffected":0,"numAtRisk":159}],"term":"Creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":156},{"groupId":"EG001","numAffected":34,"numAtRisk":159}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":136,"numAtRisk":156},{"groupId":"EG001","numAffected":127,"numAtRisk":159}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":74,"numAtRisk":156},{"groupId":"EG001","numAffected":69,"numAtRisk":159}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":156},{"groupId":"EG001","numAffected":38,"numAtRisk":159}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":156},{"groupId":"EG001","numAffected":17,"numAtRisk":159}],"term":"Fibrosis-deep connective tissue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":156},{"groupId":"EG001","numAffected":11,"numAtRisk":159}],"term":"Muscle weakness Whole body/generalized"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":156},{"groupId":"EG001","numAffected":9,"numAtRisk":159}],"term":"Osteonecrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":156},{"groupId":"EG001","numAffected":11,"numAtRisk":159}],"term":"Pain Back"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":156},{"groupId":"EG001","numAffected":9,"numAtRisk":159}],"term":"Pain Bone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":156},{"groupId":"EG001","numAffected":2,"numAtRisk":159}],"term":"Pain Extremity-limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":156},{"groupId":"EG001","numAffected":10,"numAtRisk":159}],"term":"Pain Joint"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":156},{"groupId":"EG001","numAffected":29,"numAtRisk":159}],"term":"Pain Neck"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":156},{"groupId":"EG001","numAffected":23,"numAtRisk":159}],"term":"Trismus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":156},{"groupId":"EG001","numAffected":17,"numAtRisk":159}],"term":"Pain Tumor pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":156},{"groupId":"EG001","numAffected":10,"numAtRisk":159}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":156},{"groupId":"EG001","numAffected":8,"numAtRisk":159}],"term":"Neuropathy-motor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":61,"numAtRisk":156},{"groupId":"EG001","numAffected":24,"numAtRisk":159}],"term":"Neuropathy-sensory"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":156},{"groupId":"EG001","numAffected":34,"numAtRisk":159}],"term":"Pain Head/headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":142,"numAtRisk":156},{"groupId":"EG001","numAffected":139,"numAtRisk":159}],"term":"Taste alteration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":156},{"groupId":"EG001","numAffected":46,"numAtRisk":159}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":156},{"groupId":"EG001","numAffected":32,"numAtRisk":159}],"term":"Mood alteration Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":156},{"groupId":"EG001","numAffected":13,"numAtRisk":159}],"term":"Mood alteration 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