{"description":"The \"Other Adverse Events\" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":150,"description":"The Safety Analysis Set includes all subjects who received any amount of study drug.","id":"EG000","otherNumAffected":34,"otherNumAtRisk":150,"seriousNumAffected":22,"seriousNumAtRisk":150,"title":"Safety Analysis Set"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":150}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":150}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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(20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150}],"term":"Hyponatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150}],"term":"Metabolic acidosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":150}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150}],"term":"Renal impairment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150}],"term":"Sinus 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(20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150}],"term":"Cholelithiasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150}],"term":"Ischaemic stroke"}],"timeFrame":"Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days)."}