{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":55,"description":"Gabapentin liquid by mouth or per Tube 300mg twice a day","id":"EG000","otherNumAffected":46,"otherNumAtRisk":55,"seriousNumAffected":0,"seriousNumAtRisk":55,"title":"Gabapentin"},{"deathsNumAffected":1,"deathsNumAtRisk":55,"description":"Placebo liquid by mouth or Per Tube twice a day","id":"EG001","otherNumAffected":50,"otherNumAtRisk":55,"seriousNumAffected":0,"seriousNumAtRisk":55,"title":"Placebo"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Acute renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":2,"numAtRisk":55}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Airway bleed"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Airway edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":3,"numAtRisk":55}],"term":"Alkalosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Allergic contact dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":55},{"groupId":"EG001","numAffected":35,"numAtRisk":55}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":55},{"groupId":"EG001","numAffected":2,"numAtRisk":55}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":55},{"groupId":"EG001","numAffected":2,"numAtRisk":55}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Atrioventricular block"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Bleeding at wound site"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Bloody sputum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Blurry vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":55},{"groupId":"EG001","numAffected":7,"numAtRisk":55}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Chronic kidney disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Chylothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Congestive heart failure exacerbation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Delerium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Delirium/alcohol withdrawal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":3,"numAtRisk":55}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Diplopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":55},{"groupId":"EG001","numAffected":2,"numAtRisk":55}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Elevated alkaline phosphatase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Elevated liver enzymes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":55},{"groupId":"EG001","numAffected":36,"numAtRisk":55}],"term":"Elevated white blood cells"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Eye pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Eye tingling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":3,"numAtRisk":55}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Flap necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Hematochezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":55},{"groupId":"EG001","numAffected":2,"numAtRisk":55}],"term":"Hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Hematoma at flap site"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Hemorrhage at resection site"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":55},{"groupId":"EG001","numAffected":5,"numAtRisk":55}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":55},{"groupId":"EG001","numAffected":3,"numAtRisk":55}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":3,"numAtRisk":55}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Hyperphosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":55},{"groupId":"EG001","numAffected":40,"numAtRisk":55}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":55},{"groupId":"EG001","numAffected":7,"numAtRisk":55}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":2,"numAtRisk":55}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":3,"numAtRisk":55}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":55},{"groupId":"EG001","numAffected":9,"numAtRisk":55}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Hypoparathyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":55},{"groupId":"EG001","numAffected":6,"numAtRisk":55}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":55},{"groupId":"EG001","numAffected":3,"numAtRisk":55}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":55},{"groupId":"EG001","numAffected":2,"numAtRisk":55}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Iatrogenic bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Lactic acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Laryngeal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Laryngeal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Left arm surgical site cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Left neck numbness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Left shoulder weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Left upper extremity swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Microcytic anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Myasthenia gravis exacerbation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":55},{"groupId":"EG001","numAffected":3,"numAtRisk":55}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Neck fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Neck hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Neck infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Nonsustained ventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Oral wound dehiscence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Oropharyngeal bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Orthostasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Oxygen desaturation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Parasthesia (right foot)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Pharyngeal leak"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Pressure ulcer - coccyx"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Pulmonary edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Pulmonary effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Rectal bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Reflux"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Respiratory acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Right upper extremity tingling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Sensation of reflux/burning with tube feeds"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":2,"numAtRisk":55}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":55},{"groupId":"EG001","numAffected":12,"numAtRisk":55}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Stoma bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Stoma dehiscence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Superficial dehiscence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Superior thryroid artery bleed hematemesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Surgical site infection (MRSA)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":55},{"groupId":"EG001","numAffected":2,"numAtRisk":55}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Thrombocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Tongue edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":0,"numAtRisk":55}],"term":"Tracheitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":3,"numAtRisk":55}],"term":"Tracheostomy site bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Ventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":55},{"groupId":"EG001","numAffected":3,"numAtRisk":55}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Wound breakdown"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":55},{"groupId":"EG001","numAffected":2,"numAtRisk":55}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Wound necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Wound dehiscence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":55},{"groupId":"EG001","numAffected":1,"numAtRisk":55}],"term":"Hypochloremia"}],"timeFrame":"Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3."}