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(Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":22,"numEvents":3}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Myocardial infarction (NSTEMI)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Renal and urinary disorders - other, UTI sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22,"numEvents":3}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Upper gastrointestinal bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22,"numEvents":2}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22,"numEvents":1}],"term":"Urine output decreased"}],"timeFrame":"First day of treatment through the end of treatment visit. Duration of subject treatment varied from 2 months to 24 months."}