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increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Acute interstitial pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Respiratory distress"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Hypotension"}],"timeFrame":"From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 12 October 2015; median duration of treatment was 14 weeks in the normal renal function group and 12 weeks in the ESRD group."}