{"eventGroups":[{"description":"Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy","id":"EG000","otherNumAffected":30,"otherNumAtRisk":31,"seriousNumAffected":3,"seriousNumAtRisk":31,"title":"Continuum Device"}],"frequencyThreshold":"0","otherEvents":[{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":31,"numEvents":26}],"term":"Urinary Incontinence - De Novo"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":31,"numEvents":12}],"term":"Pain/Discomfort"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":31,"numEvents":13}],"term":"Pain/Discomfort - Other"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":8}],"term":"Hematuria"},{"organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":31,"numEvents":18}],"term":"Erectile Dysfunction - De Novo"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":31,"numEvents":8}],"term":"Pain/Discomfort - Abdominal"},{"organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Erectile Dysfunction - Worsening"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Infection"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Urinary Tract Infection (UTI)"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Urinary Retention"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Dysuria"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"False Passage"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Perforation - Bladder"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Nausea"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Pain/Discomfort - Back"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Nocturia"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":2}],"term":"Dizziness"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Abdominal Bloating/Gas"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Constipation"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Fluid Overload (Hypervolemia)"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Loss of appetite"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Actelectasis"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Bladder Spasm"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Clot in catheter"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Disease progession"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Hemorrhoid"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Increased Creatinine"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Inguinal Hernia"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Kidney Stone"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Light Headed"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Tunnel Vision"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Vasovagal Reaction"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":5}],"term":"Bladder Neck Contracture/Outlet Obstruct"}],"seriousEvents":[{"organSystem":"Surgical and medical procedures","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Excessive bleeding"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Bladder Neck Contracture/Outlet Obstruct"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Separation/Disruption of Anastomosis"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Syncope"}],"timeFrame":"Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up"}