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increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":239},{"groupId":"EG001","numAffected":12,"numAtRisk":220},{"groupId":"EG002","numAffected":19,"numAtRisk":240}],"term":"Aspartate aminotransferase increased"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":0,"numAtRisk":240}],"term":"Cardiac failure acute"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":1,"numAtRisk":240}],"term":"Myocardial ischaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":0,"numAtRisk":240}],"term":"Cataract"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":1,"numAtRisk":240}],"term":"Oedematous pancreatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":1,"numAtRisk":240}],"term":"Drug-induced liver injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":1,"numAtRisk":240}],"term":"Hepatitis acute"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":1,"numAtRisk":240}],"term":"Hepatitis chronic active"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 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19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":1,"numAtRisk":240}],"term":"Meningioma benign"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":0,"numAtRisk":240}],"term":"Non-small cell lung cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":0,"numAtRisk":240}],"term":"Oesophageal neoplasm"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":1,"numAtRisk":240}],"term":"Pleomorphic adenoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":0,"numAtRisk":240}],"term":"Cerebral haematoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 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Version 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":1,"numAtRisk":240}],"term":"Pustular psoriasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":0,"numAtRisk":240}],"term":"Deep vein thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":1,"numAtRisk":240}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":239},{"groupId":"EG001","numAffected":0,"numAtRisk":220},{"groupId":"EG002","numAffected":1,"numAtRisk":240}],"term":"Hypertensive crisis"}],"timeFrame":"Up to 60 Weeks"}