{"eventGroups":[{"description":"Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg","id":"EG000","otherNumAffected":161,"otherNumAtRisk":256,"seriousNumAffected":40,"seriousNumAtRisk":256,"title":"Fulvestrant + Anastrozole"},{"description":"Anastrozole 1 mg","id":"EG001","otherNumAffected":178,"otherNumAtRisk":254,"seriousNumAffected":45,"seriousNumAtRisk":254,"title":"Anastrozole"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":256},{"groupId":"EG001","numAffected":27,"numAtRisk":254}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":256},{"groupId":"EG001","numAffected":12,"numAtRisk":254}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":256},{"groupId":"EG001","numAffected":13,"numAtRisk":254}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":256},{"groupId":"EG001","numAffected":9,"numAtRisk":254}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":256},{"groupId":"EG001","numAffected":33,"numAtRisk":254}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":256},{"groupId":"EG001","numAffected":8,"numAtRisk":254}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":256},{"groupId":"EG001","numAffected":27,"numAtRisk":254}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":256},{"groupId":"EG001","numAffected":20,"numAtRisk":254}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":256},{"groupId":"EG001","numAffected":15,"numAtRisk":254}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":256},{"groupId":"EG001","numAffected":13,"numAtRisk":254}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":256},{"groupId":"EG001","numAffected":9,"numAtRisk":254}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":256},{"groupId":"EG001","numAffected":19,"numAtRisk":254}],"term":"Hot flush"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Cardiac Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":2,"numAtRisk":254}],"term":"Pericardial Effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Angina Pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Atrial Flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Cardiac Arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Atrial Fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Myocardial Infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Ventricular Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":2,"numAtRisk":254}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":256},{"groupId":"EG001","numAffected":2,"numAtRisk":254}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Abdominal Pain Upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":3,"numAtRisk":254}],"term":"General Physical Health Deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":2,"numAtRisk":254}],"term":"Chest Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":2,"numAtRisk":254}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Oedema Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":256},{"groupId":"EG001","numAffected":2,"numAtRisk":254}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":2,"numAtRisk":254}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Gangrene"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Viral Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Bronchpneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":2,"numAtRisk":254}],"term":"Humerus Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Femur Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Hip Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Pelvic Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Femoral Neck Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Fractured Sacrum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Head Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Joint Dislocation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Subdural Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Blood Creatinine Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":2,"numAtRisk":254}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":2,"numAtRisk":254}],"term":"Muscular Weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Musculoskeletal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Pain In Extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Rhabdomyolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Spinal Column Stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Osteonecrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Basal Cell Carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Meningioma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Metastases To Meninges"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Ovarian Cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":256},{"groupId":"EG001","numAffected":2,"numAtRisk":254}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Intracranial Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Peripheral Sensory Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Cerebellar Infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Cerebral Infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Peripheral Motor Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Spinal Cord Compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Syncope Vasovagal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Schizophrenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Confusional State"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Renal Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":256},{"groupId":"EG001","numAffected":2,"numAtRisk":254}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Pleural Effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Pulmonary Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Pleuritic Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Respiratory Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Angioedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Foot Amputation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":256},{"groupId":"EG001","numAffected":1,"numAtRisk":254}],"term":"Venous Stasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":256},{"groupId":"EG001","numAffected":0,"numAtRisk":254}],"term":"Thrombosis"}]}