{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"42"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"}],"units":"Participants"}],"description":"The primary efficacy endpoint was the number of patients attaining complete response (CR) at the end of the treatment period (Primary Disease Evaluation (PDE) visit). The CR was defined dichotomously as \"Success\" if CR was confirmed at PDE visit (or relevant follow-up), and \"Failure\" otherwise.","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. Upon 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 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":"An average of 11 weeks","title":"The Primary Efficacy Endpoint Was the Number of Patients Attaining Complete Response (CR) at the End of the Treatment Period (PDE Visit).","type":"PRIMARY","unitOfMeasure":"Participants"}