{"description":"All randomized participants","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":40,"description":"Lenalidomide\n\n25 mg taken orally once daily, Days 1 - 21 of each cycle\n\nDexamethasone\n\nAdministered on Days 1, 8, 15, and 22 of each cycle:\n\nOn weeks when elotuzumab is administered:\n\n* 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND\n* 8 mg IV (at least 45 minutes prior to elotuzumab administration)\n\nOn weeks when elotuzumab is NOT administered:\n\n\\- 40 mg taken orally\n\nElotuzumab (BMS-901608)\n\n* Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22\n* Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15\n* Cycle 19 and beyond: 20 mg/kg IV, Day 1","id":"EG000","otherNumAffected":39,"otherNumAtRisk":40,"seriousNumAffected":26,"seriousNumAtRisk":40,"title":"Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)"},{"deathsNumAffected":6,"deathsNumAtRisk":42,"description":"Lenalidomide\n\n25 mg taken orally once a day, Days 1 - 21 of each cycle\n\nDexamethasone\n\n40 mg taken orally, Days 1, 8, 15, and 22 of each cycle","id":"EG001","otherNumAffected":42,"otherNumAtRisk":42,"seriousNumAffected":27,"seriousNumAtRisk":42,"title":"Arm B: Lenalidomide + Dexamethasone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":40},{"groupId":"EG001","numAffected":6,"numAtRisk":42}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":40},{"groupId":"EG001","numAffected":9,"numAtRisk":42}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":40},{"groupId":"EG001","numAffected":12,"numAtRisk":42}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Glaucoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Abdominal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Chronic gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":40},{"groupId":"EG001","numAffected":13,"numAtRisk":42}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Dental caries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":40},{"groupId":"EG001","numAffected":12,"numAtRisk":42}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40},{"groupId":"EG001","numAffected":5,"numAtRisk":42}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Periodontal disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":40},{"groupId":"EG001","numAffected":12,"numAtRisk":42}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":40},{"groupId":"EG001","numAffected":5,"numAtRisk":42}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Gingivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Hepatitis B reactivation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Herpes virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":40},{"groupId":"EG001","numAffected":18,"numAtRisk":42}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Oral herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Osteomyelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Periodontitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40},{"groupId":"EG001","numAffected":8,"numAtRisk":42}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":40},{"groupId":"EG001","numAffected":5,"numAtRisk":42}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Skin abrasion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Spinal compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Tooth fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Creatinine renal clearance decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":40},{"groupId":"EG001","numAffected":13,"numAtRisk":42}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":8,"numAtRisk":42}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":4,"numAtRisk":42}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Musculoskeletal stiffness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":6,"numAtRisk":42}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":40},{"groupId":"EG001","numAffected":9,"numAtRisk":42}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":40},{"groupId":"EG001","numAffected":11,"numAtRisk":42}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Chronic kidney disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Renal impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":5,"numAtRisk":42}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":40},{"groupId":"EG001","numAffected":6,"numAtRisk":42}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":40},{"groupId":"EG001","numAffected":17,"numAtRisk":42}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":3,"numAtRisk":42}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Agranulocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Disseminated intravascular coagulation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Cardiac failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Eosinophilic myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":40},{"groupId":"EG001","numAffected":7,"numAtRisk":42}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Cataract subcapsular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Dental caries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Ileus paralytic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Ischaemic enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Lower gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Generalised oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Sudden death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Bile duct stone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Disseminated varicella zoster virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Osteomyelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Peri-implantitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40},{"groupId":"EG001","numAffected":7,"numAtRisk":42}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Pneumonia cryptococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Pneumonia influenzal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Humerus fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Near drowning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Spinal compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":2,"numAtRisk":42}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Chondrocalcinosis pyrophosphate"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Gastrointestinal stromal tumour"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Lung neoplasm malignant"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Papillary thyroid cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Rectal cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Subarachnoid haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Prostatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Drug reaction with eosinophilia and systemic symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Cataract operation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40},{"groupId":"EG001","numAffected":0,"numAtRisk":42}],"term":"Circulatory collapse"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40},{"groupId":"EG001","numAffected":1,"numAtRisk":42}],"term":"Deep vein thrombosis"}],"timeFrame":"All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months)."}