{"description":"Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.","eventGroups":[{"description":"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \\> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.\n\nIf the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.","id":"EG000","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":5,"seriousNumAtRisk":12,"title":"Carfilzomib - Normal RF"},{"description":"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.\n\nIf the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.","id":"EG001","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":8,"seriousNumAtRisk":12,"title":"Carfilzomib - Mild RI"},{"description":"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.\n\nIf the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.","id":"EG002","otherNumAffected":10,"otherNumAtRisk":10,"seriousNumAffected":10,"seriousNumAtRisk":10,"title":"Carfilzomib - Moderate RI"},{"description":"Participants with severe renal impairment (CrCL \\< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.\n\nIf the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.","id":"EG003","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":6,"seriousNumAtRisk":8,"title":"Carfilzomib - Severe RI"},{"description":"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.\n\nIf the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.","id":"EG004","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":8,"seriousNumAtRisk":8,"title":"Carfilzomib - Dialysis"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":12},{"groupId":"EG001","numAffected":7,"numAtRisk":12},{"groupId":"EG002","numAffected":7,"numAtRisk":10},{"groupId":"EG003","numAffected":5,"numAtRisk":8},{"groupId":"EG004","numAffected":5,"numAtRisk":8}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Hypocoagulable state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Lymphadenopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":12},{"groupId":"EG001","numAffected":4,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":4,"numAtRisk":8}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":12},{"groupId":"EG001","numAffected":6,"numAtRisk":12},{"groupId":"EG002","numAffected":5,"numAtRisk":10},{"groupId":"EG003","numAffected":3,"numAtRisk":8},{"groupId":"EG004","numAffected":5,"numAtRisk":8}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Cardiac failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Dilatation atrial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Ear congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Vertigo positional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Diplopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Eye pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Keratitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Abdominal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":4,"numAtRisk":8}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Bowel sounds abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Colonic haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Colonic polyp"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12},{"groupId":"EG001","numAffected":6,"numAtRisk":12},{"groupId":"EG002","numAffected":5,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":3,"numAtRisk":8}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":12},{"groupId":"EG001","numAffected":6,"numAtRisk":12},{"groupId":"EG002","numAffected":5,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":4,"numAtRisk":8}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Hypoaesthesia oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Impaired gastric emptying"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":12},{"groupId":"EG001","numAffected":4,"numAtRisk":12},{"groupId":"EG002","numAffected":6,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":4,"numAtRisk":8}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":3,"numAtRisk":8}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Catheter site haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Catheter site inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Catheter site related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Face oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Facial pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":12},{"groupId":"EG001","numAffected":9,"numAtRisk":12},{"groupId":"EG002","numAffected":6,"numAtRisk":10},{"groupId":"EG003","numAffected":4,"numAtRisk":8},{"groupId":"EG004","numAffected":4,"numAtRisk":8}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Generalised oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Hypothermia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Infusion site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Local swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":3,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":3,"numAtRisk":12},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":4,"numAtRisk":8}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Pitting oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":4,"numAtRisk":8}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Tenderness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Seasonal allergy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Herpes simplex"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Pseudomonas infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Respiratory syncytial virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":3,"numAtRisk":8}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Staphylococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Tinea pedis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":3,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Urinary tract infection pseudomonal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Arthropod bite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Limb injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Post procedural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Post procedural vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Postoperative fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Skin injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Abdominal bruit"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Blood albumin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Blood calcium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Blood creatinine decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":5,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Blood glucose decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Blood magnesium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Blood phosphorus decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Blood phosphorus increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Blood potassium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Blood potassium increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Blood pressure diastolic decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Blood pressure increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Blood sodium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":3,"numAtRisk":8}],"term":"Blood uric acid increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Breath sounds abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Carbon dioxide decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Cardiac murmur"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"International normalised ratio increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Occult blood positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Respiratory rate decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Troponin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Urine output decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Hypermagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Hypernatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Hyperphosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":12},{"groupId":"EG001","numAffected":3,"numAtRisk":12},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":4,"numAtRisk":8}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12},{"groupId":"EG001","numAffected":4,"numAtRisk":12},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":3,"numAtRisk":8}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Lactic acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Overweight"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":12},{"groupId":"EG001","numAffected":3,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Joint range of motion decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Joint swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Nodule on extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Pain in jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":3,"numAtRisk":8}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Rotator cuff syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Sensation of heaviness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Shoulder pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Bone neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Aphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Areflexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Balance disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Diplegia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Disturbance in attention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":3,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Hyporeflexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12},{"groupId":"EG001","numAffected":4,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Neuropathic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Post herpetic neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Sinus headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Mood altered"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Azotaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Nephrolithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Nocturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Renal failure chronic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Renal impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Urinary tract pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Urine flow decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Erectile dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":12},{"groupId":"EG001","numAffected":3,"numAtRisk":12},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":3,"numAtRisk":8},{"groupId":"EG004","numAffected":3,"numAtRisk":8}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Dyspnoea exacerbated"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Nasal dryness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Pharyngolaryngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Pulmonary hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Rales"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Rhinalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Sinus congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Sneezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Tachypnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Throat irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Acne"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Blood blister"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Decubitus ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Ecchymosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Rash macular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Rash pruritic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Skin exfoliation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Skin tightness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Swelling face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":4,"numAtRisk":8}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Pallor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Superior vena caval occlusion"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Angina unstable"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Right ventricular failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Hiatus hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":3,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":3,"numAtRisk":8}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Venoocclusive liver disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Amyloidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Bronchitis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Central line infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Injection site cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":12},{"groupId":"EG002","numAffected":4,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Pneumonia bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Respiratory tract infection bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Streptococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Plasmacytoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":3,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":2,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":2,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Renal failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":1,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":1,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Pulmonary hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Respiratory alkalosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":2,"numAtRisk":8}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":1,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":0,"numAtRisk":8}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 8.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":0,"numAtRisk":12},{"groupId":"EG002","numAffected":0,"numAtRisk":10},{"groupId":"EG003","numAffected":0,"numAtRisk":8},{"groupId":"EG004","numAffected":1,"numAtRisk":8}],"term":"Superior vena caval occlusion"}],"timeFrame":"From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days."}