{"eventGroups":[{"deathsNumAffected":5,"deathsNumAtRisk":71,"description":"This was a prospective, open-label, single-arm, pivotal phase study, designed to assess the efficacy, tolerability, and safety UGN-101 treatment administered to the Upper Urinary Tract (UUT).\n\nUpon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.\n\nEligible patients with confirmed Low Grade (LG) noninvasive Upper Tract Urothelial Carcinoma (UTUC) were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the Primary Disease Evaluation (PDE) Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated complete response (CR) could enter a maintenance period and receive up to11 once-monthly instillations, per investigator modified treatment regimen.","id":"EG000","otherNumAffected":67,"otherNumAtRisk":71,"seriousNumAffected":28,"seriousNumAtRisk":71,"title":"UGN-101 Mitomycin for Pyelocalyceal Solution"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":71,"numEvents":31}],"term":"Ureteric stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":71,"numEvents":23}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 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19.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":71,"numEvents":4}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":71,"numEvents":4}],"term":"Renal Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":71,"numEvents":4}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":71,"numEvents":4}],"term":"urine abnormality"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":71,"numEvents":4}],"term":"Weight loss 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fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Cardiac failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Cardiac failure chronic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Transient global amnesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Transitional cell cancer of renal pelvis and ureter metastatic"}],"timeFrame":"The study period for Adverse Events (AEs) collection was defined from the Informed Consent Form (ICF) signature and up to 30 days following the last administration of investigational product unless the AE was suspected to be related to the study treatment or was a Serious Adverse Event, in such case the AE should be reported regardless to the timelines of the reporting period. Through study completion, an average of 15 months."}