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NCT05243550 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer · Source last updated 2026-05-11

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
Up to 21 months

What was measured

The number of patients with each type of event is summarized. TEAEs were defined as adverse events (AEs) that started on or after the day of the first instillation of UGN-102 or pre-treatment AEs that worsened during the study.

Analysis population: All patients who received any dose of UGN-102.

Groups in this outcome

UGN-102

6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).

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-102240

Reported measurements

Any TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-102137Not reportedNot reportedNot reportedNot reported
Any serious TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-10229Not reportedNot reportedNot reportedNot reported
Any TEAEs of special interest
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-102100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        137
    title
    Any TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    title
    Any serious TEAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        100
    title
    Any TEAEs of special interest
denoms
  1. counts
    1. group Id
      OG000
      value
      240
    units
    Participants
description
The number of patients with each type of event is summarized. TEAEs were defined as adverse events (AEs) that started on or after the day of the first instillation of UGN-102 or pre-treatment AEs that worsened during the study.
groups
  1. description
    6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
    id
    OG000
    title
    UGN-102
param Type
COUNT_OF_PARTICIPANTS
population Description
All patients who received any dose of UGN-102.
reporting Status
POSTED
time Frame
Up to 21 months
title
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice