{"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 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 to 11 once-monthly instillations, per investigator modified treatment regimen.","id":"FG000","title":"UGN-101 Mitomycin for Pyelocalyceal Solution"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Comorbid conditions and noncompliance"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Patient elected nephroureterectomy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"71"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"62"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"9"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}