{"description":"Adverse events (AEs) were reported from the time of informed consent to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment or study procedures were to be reported until the End of Study Visit.","eventGroups":[{"deathsNumAffected":3,"deathsNumAtRisk":240,"description":"6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).","id":"EG000","otherNumAffected":129,"otherNumAtRisk":240,"seriousNumAffected":29,"seriousNumAtRisk":240,"title":"UGN-102"}],"frequencyThreshold":"3","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":240}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":240}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":240}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":240}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":240}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":240}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":240}],"term":"Urethral stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":240}],"term":"Micturition urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":240}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":240}],"term":"Nausea"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":240}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Atrioventricular block second degree"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Cardiac failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Sinus node dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":240}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Fournier's gangrene"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Carotid artery disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Carpal tunnel syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Adenocarcinoma pancreas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Lip and/or oral cavity cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Lung cancer metastatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":240}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Urethral stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Incarcerated inguinal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Gallbladder polyp"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Jaundice cholestatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Acetabulum fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Glaucoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Intervertebral disc protrusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (25.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":240}],"term":"Hypertensive crisis"}],"timeFrame":"Up to 21 months. Study conduct is ongoing and data are summarized through a cutoff date of 04 Apr 2024. As of the data cutoff date, ongoing patients were followed through at least Study Month 15, with the earliest enrolled patients followed through Study Month 21."}