{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"41"}],"units":"Participants"}],"description":"Continuously: Duration of CR or time-to-recurrence since the Primary Disease Evaluation (PDE) Visit (i.e., time in days from the visit at which CR was determined until recurrence or censoring). This endpoint served as the main long-term durability endpoint. Dichotomously: \"Success\" if CR was still present at the 12 month post-PDE Visit (at Follow-Up Visit 4), and \"Failure\" otherwise. This endpoint served as a supportive long-term durability endpoint.","groups":[{"description":"Population was analyzed at 12 months post Primary Disease Evaluation (PDE) visit. 8 out of 41 patients had disease recurrence. The Kaplan-Meier estimate of 12 month duration of complete response (CR) rate was 82%.\n\nThis 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 CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen.","id":"OG000","title":"UGN-101 Mitomycin for Pyelocalyceal Solution"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"12 months","title":"The Key Secondary Efficacy Endpoint Was Long-term Durability of Complete Response (CR): Number of Patients Who Maintained CR at 12 Month Post PDE Visit. This Endpoint Was Defined Only for Those Patients Who Achieved CR at the PDE Visit.","type":"SECONDARY","unitOfMeasure":"Participants"}