{"description":"Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis \\& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed the AE form at least once. Serious AE (SAE) reports may include any secondary serious/non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":17,"description":"Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.","id":"EG000","otherNumAffected":15,"otherNumAtRisk":17,"seriousNumAffected":5,"seriousNumAtRisk":17,"title":"Arm A (Placebo)"},{"deathsNumAffected":0,"deathsNumAtRisk":16,"description":"Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.","id":"EG001","otherNumAffected":14,"otherNumAtRisk":16,"seriousNumAffected":0,"seriousNumAtRisk":16,"title":"Arm B (Rincinol)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":17,"numEvents":8},{"groupId":"EG001","numAffected":3,"numAtRisk":16,"numEvents":6}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":17,"numEvents":47},{"groupId":"EG001","numAffected":8,"numAtRisk":16,"numEvents":31}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Hoarseness"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Oral hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":16,"numEvents":0}],"term":"Dysgeusia"}],"timeFrame":"Adverse events are collected weekly during radiotherapy management visits"}