{"description":"Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.","eventGroups":[{"deathsNumAffected":74,"deathsNumAtRisk":287,"description":"Participants received ibrutinib 420 milligram (mg) (3 \\* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.","id":"EG000","otherNumAffected":268,"otherNumAtRisk":287,"seriousNumAffected":198,"seriousNumAtRisk":287,"title":"Ibrutinib+BR"},{"deathsNumAffected":107,"deathsNumAtRisk":287,"description":"Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.","id":"EG001","otherNumAffected":271,"otherNumAtRisk":287,"seriousNumAffected":127,"seriousNumAtRisk":287,"title":"Placebo+BR"},{"deathsNumAffected":57,"deathsNumAtRisk":183,"description":"Participants in the placebo+BR treatment group could cross over to receive next-line ibrutinib treatment (420 mg \\[3 \\* 140 mg capsules\\] orally once daily on a 28-day cycle) at the discretion of the investigator at the time of disease progression or if International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for treatment were met.","id":"EG002","otherNumAffected":157,"otherNumAtRisk":183,"seriousNumAffected":105,"seriousNumAtRisk":183,"title":"Crossover to Ibrutinib"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":73,"numAtRisk":287},{"groupId":"EG001","numAffected":79,"numAtRisk":287},{"groupId":"EG002","numAffected":33,"numAtRisk":183}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":287},{"groupId":"EG001","numAffected":18,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":170,"numAtRisk":287},{"groupId":"EG001","numAffected":159,"numAtRisk":287},{"groupId":"EG002","numAffected":40,"numAtRisk":183}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":90,"numAtRisk":287},{"groupId":"EG001","numAffected":69,"numAtRisk":287},{"groupId":"EG002","numAffected":24,"numAtRisk":183}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":287},{"groupId":"EG001","numAffected":5,"numAtRisk":287},{"groupId":"EG002","numAffected":19,"numAtRisk":183}],"term":"Atrial Fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":287},{"groupId":"EG001","numAffected":3,"numAtRisk":287},{"groupId":"EG002","numAffected":8,"numAtRisk":183}],"term":"Cataract"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":287},{"groupId":"EG001","numAffected":9,"numAtRisk":287},{"groupId":"EG002","numAffected":6,"numAtRisk":183}],"term":"Dry Eye"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":287},{"groupId":"EG001","numAffected":19,"numAtRisk":287},{"groupId":"EG002","numAffected":3,"numAtRisk":183}],"term":"Vision Blurred"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":287},{"groupId":"EG001","numAffected":24,"numAtRisk":287},{"groupId":"EG002","numAffected":3,"numAtRisk":183}],"term":"Abdominal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":287},{"groupId":"EG001","numAffected":16,"numAtRisk":287},{"groupId":"EG002","numAffected":11,"numAtRisk":183}],"term":"Abdominal Pain Upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":61,"numAtRisk":287},{"groupId":"EG001","numAffected":50,"numAtRisk":287},{"groupId":"EG002","numAffected":15,"numAtRisk":183}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":115,"numAtRisk":287},{"groupId":"EG001","numAffected":68,"numAtRisk":287},{"groupId":"EG002","numAffected":47,"numAtRisk":183}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":287},{"groupId":"EG001","numAffected":21,"numAtRisk":287},{"groupId":"EG002","numAffected":8,"numAtRisk":183}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":287},{"groupId":"EG001","numAffected":12,"numAtRisk":287},{"groupId":"EG002","numAffected":4,"numAtRisk":183}],"term":"Gastroesophageal Reflux Disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":108,"numAtRisk":287},{"groupId":"EG001","numAffected":101,"numAtRisk":287},{"groupId":"EG002","numAffected":16,"numAtRisk":183}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":287},{"groupId":"EG001","numAffected":5,"numAtRisk":287},{"groupId":"EG002","numAffected":3,"numAtRisk":183}],"term":"Toothache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":287},{"groupId":"EG001","numAffected":45,"numAtRisk":287},{"groupId":"EG002","numAffected":15,"numAtRisk":183}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":287},{"groupId":"EG001","numAffected":24,"numAtRisk":287},{"groupId":"EG002","numAffected":5,"numAtRisk":183}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":287},{"groupId":"EG001","numAffected":31,"numAtRisk":287},{"groupId":"EG002","numAffected":5,"numAtRisk":183}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":69,"numAtRisk":287},{"groupId":"EG001","numAffected":66,"numAtRisk":287},{"groupId":"EG002","numAffected":32,"numAtRisk":183}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":287},{"groupId":"EG001","numAffected":10,"numAtRisk":287},{"groupId":"EG002","numAffected":12,"numAtRisk":183}],"term":"Influenza Like Illness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":287},{"groupId":"EG001","numAffected":7,"numAtRisk":287},{"groupId":"EG002","numAffected":3,"numAtRisk":183}],"term":"Mucosal Inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":287},{"groupId":"EG001","numAffected":13,"numAtRisk":287},{"groupId":"EG002","numAffected":3,"numAtRisk":183}],"term":"Non-Cardiac Chest Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":287},{"groupId":"EG001","numAffected":34,"numAtRisk":287},{"groupId":"EG002","numAffected":21,"numAtRisk":183}],"term":"Oedema Peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":74,"numAtRisk":287},{"groupId":"EG001","numAffected":60,"numAtRisk":287},{"groupId":"EG002","numAffected":22,"numAtRisk":183}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":287},{"groupId":"EG001","numAffected":29,"numAtRisk":287},{"groupId":"EG002","numAffected":19,"numAtRisk":183}],"term":"Bronchitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":287},{"groupId":"EG001","numAffected":8,"numAtRisk":287},{"groupId":"EG002","numAffected":10,"numAtRisk":183}],"term":"Cellulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":287},{"groupId":"EG001","numAffected":15,"numAtRisk":287},{"groupId":"EG002","numAffected":10,"numAtRisk":183}],"term":"Conjunctivitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":287},{"groupId":"EG001","numAffected":17,"numAtRisk":287},{"groupId":"EG002","numAffected":7,"numAtRisk":183}],"term":"Herpes Zoster"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":287},{"groupId":"EG001","numAffected":16,"numAtRisk":287},{"groupId":"EG002","numAffected":7,"numAtRisk":183}],"term":"Influenza"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":287},{"groupId":"EG001","numAffected":18,"numAtRisk":287},{"groupId":"EG002","numAffected":7,"numAtRisk":183}],"term":"Oral Herpes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":287},{"groupId":"EG001","numAffected":13,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Pharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":287},{"groupId":"EG001","numAffected":25,"numAtRisk":287},{"groupId":"EG002","numAffected":21,"numAtRisk":183}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":287},{"groupId":"EG001","numAffected":10,"numAtRisk":287},{"groupId":"EG002","numAffected":15,"numAtRisk":183}],"term":"Respiratory Tract Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":287},{"groupId":"EG001","numAffected":24,"numAtRisk":287},{"groupId":"EG002","numAffected":25,"numAtRisk":183}],"term":"Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":69,"numAtRisk":287},{"groupId":"EG001","numAffected":50,"numAtRisk":287},{"groupId":"EG002","numAffected":36,"numAtRisk":183}],"term":"Upper Respiratory Tract Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":287},{"groupId":"EG001","numAffected":15,"numAtRisk":287},{"groupId":"EG002","numAffected":26,"numAtRisk":183}],"term":"Urinary Tract Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":287},{"groupId":"EG001","numAffected":9,"numAtRisk":287},{"groupId":"EG002","numAffected":15,"numAtRisk":183}],"term":"Contusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":287},{"groupId":"EG001","numAffected":64,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Infusion Related Reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":287},{"groupId":"EG001","numAffected":12,"numAtRisk":287},{"groupId":"EG002","numAffected":3,"numAtRisk":183}],"term":"Alanine Aminotransferase Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":287},{"groupId":"EG001","numAffected":7,"numAtRisk":287},{"groupId":"EG002","numAffected":6,"numAtRisk":183}],"term":"Blood Creatinine Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":287},{"groupId":"EG001","numAffected":16,"numAtRisk":287},{"groupId":"EG002","numAffected":3,"numAtRisk":183}],"term":"Neutrophil Count Decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":287},{"groupId":"EG001","numAffected":9,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Platelet Count Decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":287},{"groupId":"EG001","numAffected":18,"numAtRisk":287},{"groupId":"EG002","numAffected":5,"numAtRisk":183}],"term":"Weight Decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":287},{"groupId":"EG001","numAffected":42,"numAtRisk":287},{"groupId":"EG002","numAffected":16,"numAtRisk":183}],"term":"Decreased Appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":287},{"groupId":"EG001","numAffected":20,"numAtRisk":287},{"groupId":"EG002","numAffected":7,"numAtRisk":183}],"term":"Hyperuricaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":287},{"groupId":"EG001","numAffected":12,"numAtRisk":287},{"groupId":"EG002","numAffected":8,"numAtRisk":183}],"term":"Hypokalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":287},{"groupId":"EG001","numAffected":29,"numAtRisk":287},{"groupId":"EG002","numAffected":25,"numAtRisk":183}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":287},{"groupId":"EG001","numAffected":22,"numAtRisk":287},{"groupId":"EG002","numAffected":23,"numAtRisk":183}],"term":"Back Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":287},{"groupId":"EG001","numAffected":14,"numAtRisk":287},{"groupId":"EG002","numAffected":17,"numAtRisk":183}],"term":"Muscle Spasms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":287},{"groupId":"EG001","numAffected":15,"numAtRisk":287},{"groupId":"EG002","numAffected":9,"numAtRisk":183}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":287},{"groupId":"EG001","numAffected":15,"numAtRisk":287},{"groupId":"EG002","numAffected":12,"numAtRisk":183}],"term":"Pain in Extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":287},{"groupId":"EG001","numAffected":15,"numAtRisk":287},{"groupId":"EG002","numAffected":3,"numAtRisk":183}],"term":"Dysgeusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":287},{"groupId":"EG001","numAffected":47,"numAtRisk":287},{"groupId":"EG002","numAffected":18,"numAtRisk":183}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":287},{"groupId":"EG001","numAffected":11,"numAtRisk":287},{"groupId":"EG002","numAffected":9,"numAtRisk":183}],"term":"Anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":287},{"groupId":"EG001","numAffected":8,"numAtRisk":287},{"groupId":"EG002","numAffected":4,"numAtRisk":183}],"term":"Depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":287},{"groupId":"EG001","numAffected":21,"numAtRisk":287},{"groupId":"EG002","numAffected":10,"numAtRisk":183}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":74,"numAtRisk":287},{"groupId":"EG001","numAffected":75,"numAtRisk":287},{"groupId":"EG002","numAffected":27,"numAtRisk":183}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":287},{"groupId":"EG001","numAffected":29,"numAtRisk":287},{"groupId":"EG002","numAffected":11,"numAtRisk":183}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":287},{"groupId":"EG001","numAffected":10,"numAtRisk":287},{"groupId":"EG002","numAffected":15,"numAtRisk":183}],"term":"Epistaxis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":287},{"groupId":"EG001","numAffected":9,"numAtRisk":287},{"groupId":"EG002","numAffected":4,"numAtRisk":183}],"term":"Nasal Congestion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":287},{"groupId":"EG001","numAffected":20,"numAtRisk":287},{"groupId":"EG002","numAffected":8,"numAtRisk":183}],"term":"Oropharyngeal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":287},{"groupId":"EG001","numAffected":18,"numAtRisk":287},{"groupId":"EG002","numAffected":9,"numAtRisk":183}],"term":"Productive Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":287},{"groupId":"EG001","numAffected":20,"numAtRisk":287},{"groupId":"EG002","numAffected":13,"numAtRisk":183}],"term":"Viral Upper Respiratory Tract Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":287},{"groupId":"EG001","numAffected":17,"numAtRisk":287},{"groupId":"EG002","numAffected":7,"numAtRisk":183}],"term":"Dry Skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":10,"numAtRisk":183}],"term":"Ecchymosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":10,"numAtRisk":183}],"term":"Onychoclasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":287},{"groupId":"EG001","numAffected":33,"numAtRisk":287},{"groupId":"EG002","numAffected":9,"numAtRisk":183}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":287},{"groupId":"EG001","numAffected":35,"numAtRisk":287},{"groupId":"EG002","numAffected":15,"numAtRisk":183}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":287},{"groupId":"EG001","numAffected":11,"numAtRisk":287},{"groupId":"EG002","numAffected":7,"numAtRisk":183}],"term":"Rash Maculo-Papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":287},{"groupId":"EG001","numAffected":5,"numAtRisk":287},{"groupId":"EG002","numAffected":11,"numAtRisk":183}],"term":"Skin Lesion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":287},{"groupId":"EG001","numAffected":3,"numAtRisk":287},{"groupId":"EG002","numAffected":14,"numAtRisk":183}],"term":"Haematoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":287},{"groupId":"EG001","numAffected":14,"numAtRisk":287},{"groupId":"EG002","numAffected":27,"numAtRisk":183}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":287},{"groupId":"EG001","numAffected":7,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Aplasia Pure Red Cell"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Aplastic Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":5,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Autoimmune Haemolytic Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Bone Marrow Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Cytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":287},{"groupId":"EG001","numAffected":22,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Febrile Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Haemolytic Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Immune Thrombocytopenic Purpura"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":287},{"groupId":"EG001","numAffected":6,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pancytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Acute Coronary Syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":3,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Acute Myocardial Infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Angina Pectoris"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Angina Unstable"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Arrhythmia Supraventricular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":6,"numAtRisk":183}],"term":"Atrial Fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Atrial Flutter"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Atrioventricular Block"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":3,"numAtRisk":183}],"term":"Cardiac Arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Cardiac Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Cardio-Respiratory Arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Cardiopulmonary Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Cardiovascular Insufficiency"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Carditis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Coronary Artery Occlusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Myocardial Infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Myocarditis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Pericardial Effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Sinus Node Dysfunction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Sinus Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Ventricular Fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Ventricular Flutter"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Ventricular Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Addison's Disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Goitre"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Cataract"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Maculopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Retinal Haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Scleral Disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Vitreous Adhesions"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Vitreous Haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Abdominal Hernia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Abdominal Incarcerated Hernia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":3,"numAtRisk":183}],"term":"Abdominal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Anal Fistula"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Colitis Ischaemic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Duodenal Ulcer Haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Dysphagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Enterocolitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Gastric Haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Gastric Ulcer Perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Gastritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Gastrointestinal Disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Gastrointestinal Haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Gastrointestinal Inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Haematemesis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Haematochezia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Inguinal Hernia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Intestinal Obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Intra-Abdominal Haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Large Intestine Perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Lower Gastrointestinal Haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Mouth Ulceration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Oesophageal Ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Oesophagitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Pancreatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pancreatitis Acute"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Proctitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Small Intestinal Obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Volvulus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Chest Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Complication Associated with Device"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Condition Aggravated"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Death"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Disease Progression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"General Physical Health Deterioration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Hernia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Influenza Like Illness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Infusion Site Extravasation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Malaise"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Mucosal Inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":3,"numAtRisk":287},{"groupId":"EG002","numAffected":3,"numAtRisk":183}],"term":"Multiple Organ Dysfunction Syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Non-Cardiac Chest Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Oedema Peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pneumatosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":287},{"groupId":"EG001","numAffected":7,"numAtRisk":287},{"groupId":"EG002","numAffected":4,"numAtRisk":183}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Sudden Cardiac Death"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Sudden Death"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Systemic Inflammatory Response Syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Cholangitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Cholecystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Cholecystitis Acute"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Cholecystitis Chronic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Cholelithiasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Cholestasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Gallbladder Obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Hepatic Cirrhosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Hepatitis Toxic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Hepatocellular Injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Hepatosplenomegaly"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Anaphylactic Reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Abscess Jaw"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Actinomycotic Pulmonary Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Acute Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Appendicitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Arthritis Bacterial"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Ascariasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Atypical Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Bacteraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Brain Abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Breast Abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Breast Cellulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":287},{"groupId":"EG001","numAffected":5,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Bronchitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Bronchopulmonary Aspergillosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Campylobacter Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Cellulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Cellulitis Staphylococcal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Central Nervous System Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Chronic Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Clostridium Difficile Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Clostridium Difficile Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Conjunctivitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Cystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Cytomegalovirus Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Cytomegalovirus Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Dacryocystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Dermo-Hypodermitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Disseminated Cryptococcosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Epstein-Barr Virus Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":3,"numAtRisk":183}],"term":"Erysipelas"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Escherichia Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Escherichia Urinary Tract Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Fungal Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Gastroenteritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Gastroenteritis Viral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Gastrointestinal Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Haemophilus Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Hepatitis B Reactivation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Herpes Zoster"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Infectious Pleural Effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Influenza"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Laryngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Lower Respiratory Tract Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":287},{"groupId":"EG001","numAffected":3,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Lung Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Lymphadenitis Bacterial"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Muscle Abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Neutropenic Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Nocardiosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Oral Candidiasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Osteomyelitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Otitis Media"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Periodontitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Periorbital Cellulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Peritonsillar Abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pharyngeal Abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pharyngitis Streptococcal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pneumocystis Jirovecii Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":287},{"groupId":"EG001","numAffected":26,"numAtRisk":287},{"groupId":"EG002","numAffected":34,"numAtRisk":183}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pneumonia Bacterial"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pneumonia Haemophilus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Pneumonia Pneumococcal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Pneumonia Streptococcal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Progressive Multifocal Leukoencephalopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pseudomembranous Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pulmonary Tuberculoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pulmonary Tuberculosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pyelonephritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Rash Pustular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Respiratory Syncytial Virus Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":5,"numAtRisk":183}],"term":"Respiratory Tract Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":287},{"groupId":"EG001","numAffected":4,"numAtRisk":287},{"groupId":"EG002","numAffected":4,"numAtRisk":183}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":5,"numAtRisk":183}],"term":"Septic Shock"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Skin Candida"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Skin Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Soft Tissue Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Splenic Abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Staphylococcal Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Staphylococcal Skin Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Subcutaneous Abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Tooth Abscess"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Tuberculosis of Central Nervous System"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":287},{"groupId":"EG001","numAffected":3,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Upper Respiratory Tract Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Urinary Tract Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Urosepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Varicella"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Varicella Zoster Virus Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Viral Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Abdominal Injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Ankle Fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Fall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Femoral Neck Fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Femur Fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Hip Fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Incision Site Haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":287},{"groupId":"EG001","numAffected":5,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Infusion Related Reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pelvic Fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pneumoconiosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pneumothorax Traumatic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Post Procedural Haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Post Procedural Swelling"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Subdural Haematoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Thoracic Vertebral Fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Biopsy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Blood Creatinine Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Body Temperature Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Neutrophil Count Decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Prostatic Specific Antigen Increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Weight Decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Decreased Appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Diabetes Mellitus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Hypercalcaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Hyperuricaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Hyponatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Hypophosphataemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Tumour Lysis Syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Arthritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Back Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Chondrocalcinosis Pyrophosphate"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Femoroacetabular Impingement"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Groin Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Lumbar Spinal Stenosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Muscle Haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Muscular Weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Musculoskeletal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Osteoarthritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Osteonecrosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Pain in Extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Acute Lymphocytic Leukaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Adenosquamous Cell Lung Cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Anal Squamous Cell Carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Basal Cell Carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Bladder Cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Bronchioloalveolar Carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Chronic Myelomonocytic Leukaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Intestinal Adenocarcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Intraductal Papilloma of Breast"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Lipoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Lung Adenocarcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Malignant Melanoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Malignant Melanoma in Situ"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Maxillofacial Sinus Neoplasm"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Metastases to Central Nervous System"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Metastatic Renal Cell Carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Myelodysplastic Syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Myeloproliferative Neoplasm"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Neuroendocrine Carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Prostate Cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Renal Cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Renal Cancer Stage I"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Renal Oncocytoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Squamous Cell Carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Squamous Cell Carcinoma of Skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Superficial Spreading Melanoma Stage Unspecified"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Transitional Cell Carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Carotid Sinus Syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Cerebral Disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Cerebral Infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Cerebral Ischaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Cerebrovascular Accident"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Cognitive Disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Depressed Level of Consciousness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Encephalopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Facial Paresis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Haemorrhage Intracranial"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Haemorrhagic Stroke"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Loss of Consciousness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Meningism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Peripheral Sensory Neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Post Herpetic Neuralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Radiculopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Transient Global Amnesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Vascular Encephalopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Acute Stress Disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Alcoholic Psychosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Completed Suicide"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Confusional State"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Delirium"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Mental Status Changes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Acute Kidney Injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Calculus Bladder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Dysuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Haematuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Nephropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Nephropathy Toxic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Renal Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Renal Impairment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Ureteric Stenosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Ureterolithiasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Urge Incontinence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Urinary Incontinence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Urinary Retention"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Benign Prostatic Hyperplasia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Fibrocystic Breast Disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Genital Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Pelvic Floor Muscle Weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Penile Dysplasia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Uterine Haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Uterine Prolapse"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Acute Respiratory Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Chronic Obstructive Pulmonary Disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":3,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Dyspnoea Exertional"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Haemoptysis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Haemothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Lung Infiltration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":2,"numAtRisk":183}],"term":"Pleural Effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pleuritic Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Pneumonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Pneumothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pulmonary Congestion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Pulmonary Mass"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pulmonary Sarcoidosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":3,"numAtRisk":183}],"term":"Respiratory Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Respiratory Tract Oedema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Sleep Apnoea Syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Acute Febrile Neutrophilic Dermatosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Cellulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Drug Eruption"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Excessive Granulation Tissue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Hypersensitivity Vasculitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pemphigoid"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Pemphigus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":2,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Rash Erythematous"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Rash Maculo-Papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Skin Necrosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Urticaria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Aortic Aneurysm Rupture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Arterial Stenosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":3,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Deep Vein Thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Haematoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":1,"numAtRisk":183}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Hypertensive Crisis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Jugular Vein Thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Lymphoedema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Peripheral Arterial Occlusive Disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Peripheral Artery Occlusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Peripheral Artery Thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Peripheral Ischaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Thrombophlebitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":287},{"groupId":"EG001","numAffected":0,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":287},{"groupId":"EG001","numAffected":1,"numAtRisk":287},{"groupId":"EG002","numAffected":0,"numAtRisk":183}],"term":"Vasculitis"}],"timeFrame":"From the time a signed and dated informed consent form is obtained until 30 days following the last dose of study treatment or until the start of a subsequent systemic antineoplastic therapy, if earlier (up to 5 years)"}