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NCT02793128 · OUTCOME

Safety Adverse Event Outcomes: Safety Was Monitored Throughout the Study by Reviewing Adverse Events (AEs).

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Through study completion, an average of 15 months

What was measured

Treatment-emergent AEs were most frequently reported from the Renal and urinary disorders system organ class (SOC), 59 (83.1%) patients, as expected, given the underlying indication of low grade (LG) Upper tract urothelial carcinoma (UTUC) in the study population, chemotherapeutic drug in a gel matrix instilled in the upper urinary tract (UUT), and the study procedure of treatment instillation via a ureteral catheter. The toxicity within the upper urinary tract was considered consistent with the disease under study and the mode of administration of UGN-101. Most events in the Renal and urinary disorders SOC were mild to moderate in severity and resolved. No new risks were identified and the overall safety profile was consistent with the known safety profile of endoscopic administration of intravesical mitomycin and of mitomycin. Overall, based on the safety and efficacy results to date, the benefit-risk profile of UGN-101 is favorable for the treatment of LG-UTUC.

Analysis population: Safety: Consisted of all patients who enrolled in the study and received at least 1 instillation of UGN-101.

Groups in this outcome

UGN-101 Mitomycin for Pyelocalyceal Solution

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 PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated complete response (CR) could enter a maintenance period and receive up to11 once-monthly instillations, per investigator modified treatment regimen.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
UGN-101 Mitomycin for Pyelocalyceal Solution71

Reported measurements

Treatment-emergent Adverse Events (TEAEs)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-101 Mitomycin for Pyelocalyceal Solution67Not reportedNot reportedNot reportedNot reported
TEAEs related to study drug
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-101 Mitomycin for Pyelocalyceal Solution52Not reportedNot reportedNot reportedNot reported
TEAEs related to study procedure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-101 Mitomycin for Pyelocalyceal Solution55Not reportedNot reportedNot reportedNot reported
TEAEs related to study drug or preocedure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-101 Mitomycin for Pyelocalyceal Solution61Not reportedNot reportedNot reportedNot reported
Serious Adverse Events (SAE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-101 Mitomycin for Pyelocalyceal Solution28Not reportedNot reportedNot reportedNot reported
SAEs related to study drug or procedure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-101 Mitomycin for Pyelocalyceal Solution19Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        67
    title
    Treatment-emergent Adverse Events (TEAEs)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        52
    title
    TEAEs related to study drug
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        55
    title
    TEAEs related to study procedure
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        61
    title
    TEAEs related to study drug or preocedure
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        28
    title
    Serious Adverse Events (SAE)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    SAEs related to study drug or procedure
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    units
    Participants
description
Treatment-emergent AEs were most frequently reported from the Renal and urinary disorders system organ class (SOC), 59 (83.1%) patients, as expected, given the underlying indication of low grade (LG) Upper tract urothelial carcinoma (UTUC) in the study population, chemotherapeutic drug in a gel matrix instilled in the upper urinary tract (UUT), and the study procedure of treatment instillation via a ureteral catheter. The toxicity within the upper urinary tract was considered consistent with the disease under study and the mode of administration of UGN-101. Most events in the Renal and urinary disorders SOC were mild to moderate in severity and resolved. No new risks were identified and the overall safety profile was consistent with the known safety profile of endoscopic administration of intravesical mitomycin and of mitomycin. Overall, based on the safety and efficacy results to date, the benefit-risk profile of UGN-101 is favorable for the treatment of LG-UTUC.
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 PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated complete response (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
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety: Consisted of all patients who enrolled in the study and received at least 1 instillation of UGN-101.
reporting Status
POSTED
time Frame
Through study completion, an average of 15 months
title
Safety Adverse Event Outcomes: Safety Was Monitored Throughout the Study by Reviewing Adverse Events (AEs).
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice