{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"}],"units":"Participants"}],"description":"Clinical benefit for patients with partial response (PR) at the PDE visit. Clinical benefit endpoint was analyzed using the Intent-to-Treat (ITT) Analysis Set, including patients who achieved partial response at PDE Visit.Partial response at PDE visit will be defined dichotomously, similarly to the primary efficacy endpoint. For subjects with partial response at PDE visit, originally planned and actual treatments will be compared.","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 UUT.\n\nUpon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.\n\nEligible patients with confirmed LG noninvasive 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 to11 once-monthly instillations, per investigator modified treatment regimen.","id":"OG000","title":"UGN-101 Mitomycin for Pyelocalyceal Solution"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"An average of 11 weeks","title":"Clinical Benefit for Patients With Partial Response (PR) at the Primary Disease Evaluation (PDE) Visit. Clinical Benefit Endpoint Was Analyzed Using the Intent-to-Treat (ITT) Analysis Set, Including Patients Who Achieved Partial Response at PDE Visit.","type":"SECONDARY","unitOfMeasure":"Participants"}