{"description":"All grades of rash and pain were recorded. For all other adverse events, only grade 3 and higher events and events that led to a dose reduction or delay were recorded.","eventGroups":[{"description":"Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.","id":"EG000","otherNumAffected":87,"otherNumAtRisk":96,"seriousNumAffected":32,"seriousNumAtRisk":96,"title":"Arm A (Cisplatin and Radiotherapy)"},{"description":"Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.","id":"EG001","otherNumAffected":91,"otherNumAtRisk":95,"seriousNumAffected":38,"seriousNumAtRisk":95,"title":"Arm B (Cisplatin, Radiotherapy, Erlotinib)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":96},{"groupId":"EG001","numAffected":65,"numAtRisk":95}],"term":"dermatitis, rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":96},{"groupId":"EG001","numAffected":50,"numAtRisk":95}],"term":"pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":96},{"groupId":"EG001","numAffected":28,"numAtRisk":95}],"term":"mucositis, nausea, vomiting, dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":96},{"groupId":"EG001","numAffected":14,"numAtRisk":95}],"term":"Cytopenias"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":96},{"groupId":"EG001","numAffected":0,"numAtRisk":95}],"term":"hearing loss"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":96},{"groupId":"EG001","numAffected":1,"numAtRisk":95}],"term":"Cytopenias"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":96},{"groupId":"EG001","numAffected":16,"numAtRisk":95}],"term":"nausea,vomiting, dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":96},{"groupId":"EG001","numAffected":2,"numAtRisk":95}],"term":"mucositis, esophagitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":96},{"groupId":"EG001","numAffected":1,"numAtRisk":95}],"term":"peritonitis, perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":96},{"groupId":"EG001","numAffected":1,"numAtRisk":95}],"term":"hyponatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":96},{"groupId":"EG001","numAffected":5,"numAtRisk":95}],"term":"elevated creatinine"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":96},{"groupId":"EG001","numAffected":3,"numAtRisk":95}],"term":"pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":96},{"groupId":"EG001","numAffected":2,"numAtRisk":95}],"term":"Pulmonary embolism, deep vein thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":96},{"groupId":"EG001","numAffected":1,"numAtRisk":95}],"term":"mood alteration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":96},{"groupId":"EG001","numAffected":2,"numAtRisk":95}],"term":"Substance abuse, seizure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":96},{"groupId":"EG001","numAffected":3,"numAtRisk":95}],"term":"congestive heart disease, cardiac arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":96},{"groupId":"EG001","numAffected":2,"numAtRisk":95}],"term":"Respiratory arrest, hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":96},{"groupId":"EG001","numAffected":0,"numAtRisk":95}],"term":"renal failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":96},{"groupId":"EG001","numAffected":0,"numAtRisk":95}],"term":"tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":96},{"groupId":"EG001","numAffected":0,"numAtRisk":95}],"term":"pharyngeal hemorrhage"}],"timeFrame":"Serious adverse events were collected from the first day of study therapy through 30 days following the last day of study therapy."}