{"description":"The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported.","eventGroups":[{"description":"Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.","id":"EG000","otherNumAffected":10,"otherNumAtRisk":74,"seriousNumAffected":0,"seriousNumAtRisk":74,"title":"Arm I (Doxepin-Placebo)"},{"description":"Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.","id":"EG001","otherNumAffected":8,"otherNumAtRisk":75,"seriousNumAffected":0,"seriousNumAtRisk":75,"title":"Arm II (Placebo-Doxepin)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":74,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":74,"numEvents":9},{"groupId":"EG001","numAffected":6,"numAtRisk":75,"numEvents":12}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":75,"numEvents":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":74,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":75,"numEvents":2}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Salivary duct inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":74,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":75,"numEvents":2}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":74,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":75,"numEvents":2}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":74,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":75,"numEvents":2}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Cough"}],"timeFrame":"Adverse events are assessed during the Active Monitoring Phase at the following time points: at time Dose 1 of study treatment is administered, at time of Dose 2 crossover, during the Optional Continuation Phase, and at the end of the study. All adverse events are collected during the first day; up to 9 days."}