{"description":"The population comprised all participants who were enrolled into CS21A and who received at least one dose of degarelix during the study.","eventGroups":[{"description":"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.","id":"EG000","otherNumAffected":181,"otherNumAtRisk":207,"seriousNumAffected":43,"seriousNumAtRisk":207,"title":"Degarelix 80 mg / Degarelix 80 mg"},{"description":"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.\n\nFollowing the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.","id":"EG001","otherNumAffected":177,"otherNumAtRisk":202,"seriousNumAffected":60,"seriousNumAtRisk":202,"title":"Degarelix 160 mg / Degarelix 160 mg"},{"description":"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.\n\nStarting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.\n\nFollowing the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.","id":"EG002","otherNumAffected":63,"otherNumAtRisk":69,"seriousNumAffected":23,"seriousNumAtRisk":69,"title":"Leuprolide 7.5 mg / Degarelix 80 mg"},{"description":"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.\n\nStarting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.\n\nFollowing the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.","id":"EG003","otherNumAffected":58,"otherNumAtRisk":66,"seriousNumAffected":22,"seriousNumAtRisk":66,"title":"Leuprolide 7.5 mg / Degarelix 160 mg"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":207},{"groupId":"EG001","numAffected":18,"numAtRisk":202},{"groupId":"EG002","numAffected":10,"numAtRisk":69},{"groupId":"EG003","numAffected":6,"numAtRisk":66}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":207},{"groupId":"EG001","numAffected":6,"numAtRisk":202},{"groupId":"EG002","numAffected":4,"numAtRisk":69},{"groupId":"EG003","numAffected":4,"numAtRisk":66}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":207},{"groupId":"EG001","numAffected":4,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":6,"numAtRisk":66}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":207},{"groupId":"EG001","numAffected":13,"numAtRisk":202},{"groupId":"EG002","numAffected":12,"numAtRisk":69},{"groupId":"EG003","numAffected":10,"numAtRisk":66}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":207},{"groupId":"EG001","numAffected":12,"numAtRisk":202},{"groupId":"EG002","numAffected":9,"numAtRisk":69},{"groupId":"EG003","numAffected":2,"numAtRisk":66}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":207},{"groupId":"EG001","numAffected":15,"numAtRisk":202},{"groupId":"EG002","numAffected":3,"numAtRisk":69},{"groupId":"EG003","numAffected":6,"numAtRisk":66}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":207},{"groupId":"EG001","numAffected":7,"numAtRisk":202},{"groupId":"EG002","numAffected":6,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":65,"numAtRisk":207},{"groupId":"EG001","numAffected":67,"numAtRisk":202},{"groupId":"EG002","numAffected":20,"numAtRisk":69},{"groupId":"EG003","numAffected":16,"numAtRisk":66}],"term":"Injection site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":207},{"groupId":"EG001","numAffected":51,"numAtRisk":202},{"groupId":"EG002","numAffected":10,"numAtRisk":69},{"groupId":"EG003","numAffected":16,"numAtRisk":66}],"term":"Injection site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":207},{"groupId":"EG001","numAffected":22,"numAtRisk":202},{"groupId":"EG002","numAffected":8,"numAtRisk":69},{"groupId":"EG003","numAffected":9,"numAtRisk":66}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":207},{"groupId":"EG001","numAffected":16,"numAtRisk":202},{"groupId":"EG002","numAffected":6,"numAtRisk":69},{"groupId":"EG003","numAffected":4,"numAtRisk":66}],"term":"Injection site swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":207},{"groupId":"EG001","numAffected":15,"numAtRisk":202},{"groupId":"EG002","numAffected":9,"numAtRisk":69},{"groupId":"EG003","numAffected":6,"numAtRisk":66}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":207},{"groupId":"EG001","numAffected":13,"numAtRisk":202},{"groupId":"EG002","numAffected":8,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":207},{"groupId":"EG001","numAffected":17,"numAtRisk":202},{"groupId":"EG002","numAffected":4,"numAtRisk":69},{"groupId":"EG003","numAffected":2,"numAtRisk":66}],"term":"Injection site nodule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":207},{"groupId":"EG001","numAffected":5,"numAtRisk":202},{"groupId":"EG002","numAffected":6,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Injection site inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":207},{"groupId":"EG001","numAffected":10,"numAtRisk":202},{"groupId":"EG002","numAffected":14,"numAtRisk":69},{"groupId":"EG003","numAffected":10,"numAtRisk":66}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":207},{"groupId":"EG001","numAffected":10,"numAtRisk":202},{"groupId":"EG002","numAffected":8,"numAtRisk":69},{"groupId":"EG003","numAffected":2,"numAtRisk":66}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":207},{"groupId":"EG001","numAffected":7,"numAtRisk":202},{"groupId":"EG002","numAffected":5,"numAtRisk":69},{"groupId":"EG003","numAffected":5,"numAtRisk":66}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":207},{"groupId":"EG001","numAffected":24,"numAtRisk":202},{"groupId":"EG002","numAffected":19,"numAtRisk":69},{"groupId":"EG003","numAffected":10,"numAtRisk":66}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":207},{"groupId":"EG001","numAffected":21,"numAtRisk":202},{"groupId":"EG002","numAffected":6,"numAtRisk":69},{"groupId":"EG003","numAffected":6,"numAtRisk":66}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":207},{"groupId":"EG001","numAffected":20,"numAtRisk":202},{"groupId":"EG002","numAffected":10,"numAtRisk":69},{"groupId":"EG003","numAffected":6,"numAtRisk":66}],"term":"Prostatic specific antigen increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":207},{"groupId":"EG001","numAffected":14,"numAtRisk":202},{"groupId":"EG002","numAffected":7,"numAtRisk":69},{"groupId":"EG003","numAffected":5,"numAtRisk":66}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":207},{"groupId":"EG001","numAffected":15,"numAtRisk":202},{"groupId":"EG002","numAffected":7,"numAtRisk":69},{"groupId":"EG003","numAffected":2,"numAtRisk":66}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":207},{"groupId":"EG001","numAffected":9,"numAtRisk":202},{"groupId":"EG002","numAffected":5,"numAtRisk":69},{"groupId":"EG003","numAffected":4,"numAtRisk":66}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":207},{"groupId":"EG001","numAffected":11,"numAtRisk":202},{"groupId":"EG002","numAffected":3,"numAtRisk":69},{"groupId":"EG003","numAffected":2,"numAtRisk":66}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":207},{"groupId":"EG001","numAffected":4,"numAtRisk":202},{"groupId":"EG002","numAffected":7,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":207},{"groupId":"EG001","numAffected":20,"numAtRisk":202},{"groupId":"EG002","numAffected":10,"numAtRisk":69},{"groupId":"EG003","numAffected":8,"numAtRisk":66}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":207},{"groupId":"EG001","numAffected":14,"numAtRisk":202},{"groupId":"EG002","numAffected":14,"numAtRisk":69},{"groupId":"EG003","numAffected":7,"numAtRisk":66}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":207},{"groupId":"EG001","numAffected":9,"numAtRisk":202},{"groupId":"EG002","numAffected":7,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":207},{"groupId":"EG001","numAffected":45,"numAtRisk":202},{"groupId":"EG002","numAffected":4,"numAtRisk":69},{"groupId":"EG003","numAffected":2,"numAtRisk":66}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":207},{"groupId":"EG001","numAffected":11,"numAtRisk":202},{"groupId":"EG002","numAffected":5,"numAtRisk":69},{"groupId":"EG003","numAffected":6,"numAtRisk":66}],"term":"Prostate cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":207},{"groupId":"EG001","numAffected":14,"numAtRisk":202},{"groupId":"EG002","numAffected":5,"numAtRisk":69},{"groupId":"EG003","numAffected":6,"numAtRisk":66}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":207},{"groupId":"EG001","numAffected":10,"numAtRisk":202},{"groupId":"EG002","numAffected":5,"numAtRisk":69},{"groupId":"EG003","numAffected":5,"numAtRisk":66}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":207},{"groupId":"EG001","numAffected":9,"numAtRisk":202},{"groupId":"EG002","numAffected":2,"numAtRisk":69},{"groupId":"EG003","numAffected":8,"numAtRisk":66}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":207},{"groupId":"EG001","numAffected":11,"numAtRisk":202},{"groupId":"EG002","numAffected":4,"numAtRisk":69},{"groupId":"EG003","numAffected":6,"numAtRisk":66}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":207},{"groupId":"EG001","numAffected":14,"numAtRisk":202},{"groupId":"EG002","numAffected":7,"numAtRisk":69},{"groupId":"EG003","numAffected":6,"numAtRisk":66}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":207},{"groupId":"EG001","numAffected":11,"numAtRisk":202},{"groupId":"EG002","numAffected":4,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":207},{"groupId":"EG001","numAffected":11,"numAtRisk":202},{"groupId":"EG002","numAffected":6,"numAtRisk":69},{"groupId":"EG003","numAffected":4,"numAtRisk":66}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":207},{"groupId":"EG001","numAffected":8,"numAtRisk":202},{"groupId":"EG002","numAffected":5,"numAtRisk":69},{"groupId":"EG003","numAffected":2,"numAtRisk":66}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":62,"numAtRisk":207},{"groupId":"EG001","numAffected":63,"numAtRisk":202},{"groupId":"EG002","numAffected":20,"numAtRisk":69},{"groupId":"EG003","numAffected":21,"numAtRisk":66}],"term":"Hot flush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":207},{"groupId":"EG001","numAffected":27,"numAtRisk":202},{"groupId":"EG002","numAffected":8,"numAtRisk":69},{"groupId":"EG003","numAffected":5,"numAtRisk":66}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":207},{"groupId":"EG001","numAffected":2,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":4,"numAtRisk":66}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":207},{"groupId":"EG001","numAffected":8,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":5,"numAtRisk":202},{"groupId":"EG002","numAffected":4,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":207},{"groupId":"EG001","numAffected":3,"numAtRisk":202},{"groupId":"EG002","numAffected":4,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":207},{"groupId":"EG001","numAffected":11,"numAtRisk":202},{"groupId":"EG002","numAffected":3,"numAtRisk":69},{"groupId":"EG003","numAffected":2,"numAtRisk":66}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":207},{"groupId":"EG001","numAffected":13,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Injection site induration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":207},{"groupId":"EG001","numAffected":9,"numAtRisk":202},{"groupId":"EG002","numAffected":4,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":207},{"groupId":"EG001","numAffected":6,"numAtRisk":202},{"groupId":"EG002","numAffected":4,"numAtRisk":69},{"groupId":"EG003","numAffected":4,"numAtRisk":66}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":207},{"groupId":"EG001","numAffected":10,"numAtRisk":202},{"groupId":"EG002","numAffected":5,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":207},{"groupId":"EG001","numAffected":8,"numAtRisk":202},{"groupId":"EG002","numAffected":4,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":207},{"groupId":"EG001","numAffected":5,"numAtRisk":202},{"groupId":"EG002","numAffected":4,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Blood urea increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":207},{"groupId":"EG001","numAffected":25,"numAtRisk":202},{"groupId":"EG002","numAffected":15,"numAtRisk":69},{"groupId":"EG003","numAffected":14,"numAtRisk":66}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":207},{"groupId":"EG001","numAffected":18,"numAtRisk":202},{"groupId":"EG002","numAffected":3,"numAtRisk":69},{"groupId":"EG003","numAffected":5,"numAtRisk":66}],"term":"Hypercholesterolaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":5,"numAtRisk":202},{"groupId":"EG002","numAffected":4,"numAtRisk":69},{"groupId":"EG003","numAffected":2,"numAtRisk":66}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":207},{"groupId":"EG001","numAffected":4,"numAtRisk":202},{"groupId":"EG002","numAffected":2,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":5,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Osteoporosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":207},{"groupId":"EG001","numAffected":5,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Basal cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":207},{"groupId":"EG001","numAffected":7,"numAtRisk":202},{"groupId":"EG002","numAffected":2,"numAtRisk":69},{"groupId":"EG003","numAffected":4,"numAtRisk":66}],"term":"Metastases to bone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Calculus ureteric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":207},{"groupId":"EG001","numAffected":2,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Cystitis noninfective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":207},{"groupId":"EG001","numAffected":5,"numAtRisk":202},{"groupId":"EG002","numAffected":2,"numAtRisk":69},{"groupId":"EG003","numAffected":4,"numAtRisk":66}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":207},{"groupId":"EG001","numAffected":4,"numAtRisk":202},{"groupId":"EG002","numAffected":2,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Nocturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":207},{"groupId":"EG001","numAffected":4,"numAtRisk":202},{"groupId":"EG002","numAffected":3,"numAtRisk":69},{"groupId":"EG003","numAffected":5,"numAtRisk":66}],"term":"Erectile dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":207},{"groupId":"EG001","numAffected":4,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":3,"numAtRisk":66}],"term":"Dyspnoea"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":5,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Anaemia of malignant disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Retroperitoneal lymphadenopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":2,"numAtRisk":66}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":2,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Angina unstable"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Coronary artery disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Myocardial ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":2,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":2,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Atrioventricular block second degree"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Cardio-respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Retinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":2,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Diverticular perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Diverticulum intestinal haemorrhagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Faecaloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Oedematous pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Rectal stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Subileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Umbilical hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":2,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Accidental death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Feeling abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Cholecystitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Bile duct stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Bile duct stone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Jaundice"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":207},{"groupId":"EG001","numAffected":2,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Arthritis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Cholecystitis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Empyema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Injection site abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Psoas abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Scrotal gangrene"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Humerus fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Alcohol poisoning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Ankle fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Femoral neck fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Head injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Postoperative ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Heart rate increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Type 2 diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":2,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Groin pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Intervertebral disc protrusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":207},{"groupId":"EG001","numAffected":4,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":2,"numAtRisk":66}],"term":"Prostate cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Bladder cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Colon cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Metastases to bone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Bile duct cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Bladder cancer recurrent"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Bladder papilloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Colon cancer stage II"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Gastric neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Lung neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Metastases to biliary tract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Metastases to liver"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Metastases to penis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Neoplasm malignant"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Non-hodgkin's lymphoma unspecified histology indolent"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Squamus cell carcinoma of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":2,"numAtRisk":202},{"groupId":"EG002","numAffected":2,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Cerebral haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Cerebral ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Haemorrhagic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Parkinson's disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":6,"numAtRisk":202},{"groupId":"EG002","numAffected":2,"numAtRisk":69},{"groupId":"EG003","numAffected":2,"numAtRisk":66}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Calculus bladder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":2,"numAtRisk":66}],"term":"Calculus ureteric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":3,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":2,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Renal failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":2,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Renal failure chronic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":2,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Bladder obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":2,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Ureteric stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Ecchymosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Transurethral prostatectomy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":2,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Aortic aneurysm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Lymphoedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Pallor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Varicose vein"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Iron deficiency anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Acute coronary syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Cardiopulmonary failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Myopericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Gastric haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Gastric ulcer haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Inguinal hernia obstructive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Bronchopneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Ear infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Lobar pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Post procedural cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Spinal compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"ECG signs of myocardial ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Prostate examination abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Spinal column stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Malignant lymphoma unclassifiable high grade"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Malignant melanoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":1,"numAtRisk":66}],"term":"Pleural mesothelioma malignant"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Prostate cancer metastatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Cerebrovascular insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Hyperkinesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Urethral obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":1,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Orthostatic hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":207},{"groupId":"EG001","numAffected":1,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Squamus cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":207},{"groupId":"EG001","numAffected":0,"numAtRisk":202},{"groupId":"EG002","numAffected":0,"numAtRisk":69},{"groupId":"EG003","numAffected":0,"numAtRisk":66}],"term":"Urethral stenosis"}],"timeFrame":"From start of CS21A and up to 4.5 years."}