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urinary disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":26,"numEvents":2}],"term":"Urinary tract obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Urinary tract pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":2}],"term":"Vaginal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Voice alteration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Vomiting"}],"timeFrame":"Date treatment consent signed to date off study, approximately 42 months and 28 days for the naïve group, and 40 months and 16 days for the refractory group."}