{"description":"Serious Adverse Events and adverse events were collected in the safety population which is comprised of all participants who were both randomized and received at least one dose of the study medication. Number of participants at risk represents the number of participants who received study medications.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":29,"description":"Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.","id":"EG000","otherNumAffected":18,"otherNumAtRisk":29,"seriousNumAffected":1,"seriousNumAtRisk":29,"title":"Arm I: GM-CSF Group (GG)"},{"deathsNumAffected":0,"deathsNumAtRisk":28,"description":"Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.","id":"EG001","otherNumAffected":26,"otherNumAtRisk":28,"seriousNumAffected":2,"seriousNumAtRisk":28,"title":"Arm II: Salt & Soda Group (SS)"},{"deathsNumAffected":0,"deathsNumAtRisk":28,"description":"Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.","id":"EG002","otherNumAffected":27,"otherNumAtRisk":28,"seriousNumAffected":2,"seriousNumAtRisk":28,"title":"Arm III: Salt & Soda Switched to GM-CSF (SG)"}],"frequencyThreshold":"3","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Transfusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Sinus tachycardia due to Acetaminophen-codeine medication.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Sinus Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Stomach pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(Shoulder and neck area)","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(Withdraweal symptoms-opioid)","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(Right foot)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(left parotid gland)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(bicycle accident)","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":4}],"term":"Radiation dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(\\>15 lbs; more than 10%)","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(hydrated at doctor's office during/after radiation treatment)","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":29,"numEvents":16},{"groupId":"EG001","numAffected":13,"numAtRisk":28,"numEvents":27},{"groupId":"EG002","numAffected":10,"numAtRisk":28,"numEvents":21}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Had the potential to have bone growth and had previous history. Based on physician's decision. Patient was in Salt and Soda group. This was not related to the mouth wash medication.","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Exostosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Ischemia Cerebrovascular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Acute kidney Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(chest congestion)","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Laryngopharyngeal Dyesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(mucous)","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Laryngeal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(Asymptomatic; clinical observations only; intervention not indicated; tracheostomy area)","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Laryngeal edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(due to fentanyl patch)","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":2}],"term":"Rash acne form"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(lung biopsy)","organSystem":"Surgical and medical procedures","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(Percutaneous endoscopic gastrostomy tube insertion)","organSystem":"Surgical and medical procedures","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":28,"numEvents":2}],"term":"Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(PEG tube removal)","organSystem":"Surgical and medical procedures","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(basal cell carcinoma remove from thumb)","organSystem":"Surgical and medical procedures","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(facial reconstruction)","organSystem":"Surgical and medical procedures","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"(Septoplasty)","organSystem":"Surgical and medical procedures","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Other"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Other (withdrawal symptoms-opioid)","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Mucositis Oral:Hypersensitivity Reaction from Salt and Soda Mouthwash","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Mucositis Oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Lower gastrointestinal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Reactive oral mucositis : Due to the timing of the adverse event (AE), the study team determined that the reactive oral mucositis is unlikely to be related to radiation therapy and was part of the salt and soda group.","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Allergic reaction"}],"timeFrame":"Up to 3 months"}