{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"67"}]}],"title":"Treatment-emergent Adverse Events (TEAEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"52"}]}],"title":"TEAEs related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"55"}]}],"title":"TEAEs related to study procedure"},{"categories":[{"measurements":[{"groupId":"OG000","value":"61"}]}],"title":"TEAEs related to study drug or preocedure"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28"}]}],"title":"Serious Adverse Events (SAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}],"title":"SAEs related to study drug or procedure"}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"}],"units":"Participants"}],"description":"Treatment-emergent AEs were most frequently reported from the Renal and urinary disorders system organ class (SOC), 59 (83.1%) patients, as expected, given the underlying indication of low grade (LG) Upper tract urothelial carcinoma (UTUC) in the study population, chemotherapeutic drug in a gel matrix instilled in the upper urinary tract (UUT), and the study procedure of treatment instillation via a ureteral catheter. The toxicity within the upper urinary tract was considered consistent with the disease under study and the mode of administration of UGN-101. Most events in the Renal and urinary disorders SOC were mild to moderate in severity and resolved. No new risks were identified and the overall safety profile was consistent with the known safety profile of endoscopic administration of intravesical mitomycin and of mitomycin. Overall, based on the safety and efficacy results to date, the benefit-risk profile of UGN-101 is favorable for the treatment of LG-UTUC.","groups":[{"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 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":"OG000","title":"UGN-101 Mitomycin for Pyelocalyceal Solution"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety: Consisted of all patients who enrolled in the study and received at least 1 instillation of UGN-101.","reportingStatus":"POSTED","timeFrame":"Through study completion, an average of 15 months","title":"Safety Adverse Event Outcomes: Safety Was Monitored Throughout the Study by Reviewing Adverse Events (AEs).","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}