Participant flow

The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study · Source last updated 2020-12-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. 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). Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation. Eligible 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

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Comorbid conditions and noncompliance

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Patient elected nephroureterectomy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         71

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         62

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         9

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice