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NCT05243550 · OUTCOME

Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values

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
6 months

What was measured

The number of patients with each type of event is summarized.

Analysis population: All patients who received any dose of UGN-102 and who had a post-baseline laboratory value, except for hemoglobin, which required non-missing laboratory values at baseline and post-baseline.

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

Hemoglobin < 0.8 × lower limit of normal and > 20% decrease from baseline

Analysis denominator · Participants

GroupSource count
UGN-102238
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-1028Not reportedNot reportedNot reportedNot reported
Hemoglobin > 1.3 × upper limit of normal (ULN) and > 30% increase from baseline

Analysis denominator · Participants

GroupSource count
UGN-102238
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-1020Not reportedNot reportedNot reportedNot reported
Lymphocytes < 0.5 × 10^9/L

Analysis denominator · Participants

GroupSource count
UGN-102240
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-1021Not reportedNot reportedNot reportedNot reported
Lymphocytes > 20 × 10^9/L

Analysis denominator · Participants

GroupSource count
UGN-102240
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-1020Not reportedNot reportedNot reportedNot reported
Neutrophils < 1.0 × 10^9/L

Analysis denominator · Participants

GroupSource count
UGN-102240
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-1021Not reportedNot reportedNot reportedNot reported
Platelets < 75 × 10^9/L

Analysis denominator · Participants

GroupSource count
UGN-102240
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-1021Not reportedNot reportedNot reportedNot reported
Platelets ≥ 700 × 10^9/L

Analysis denominator · Participants

GroupSource count
UGN-102240
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-1020Not reportedNot reportedNot reportedNot reported
Leukocytes ≤ 2.8 × 10^9/L

Analysis denominator · Participants

GroupSource count
UGN-102240
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-1022Not reportedNot reportedNot reportedNot reported
Leukocytes ≥ 16.0 × 10^9/L

Analysis denominator · Participants

GroupSource count
UGN-102240
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
UGN-1025Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    denoms
    1. counts
      1. group Id
        OG000
        value
        238
      units
      Participants
    title
    Hemoglobin < 0.8 × lower limit of normal and > 20% decrease from baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        238
      units
      Participants
    title
    Hemoglobin > 1.3 × upper limit of normal (ULN) and > 30% increase from baseline
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        240
      units
      Participants
    title
    Lymphocytes < 0.5 × 10^9/L
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        240
      units
      Participants
    title
    Lymphocytes > 20 × 10^9/L
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        240
      units
      Participants
    title
    Neutrophils < 1.0 × 10^9/L
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        240
      units
      Participants
    title
    Platelets < 75 × 10^9/L
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        240
      units
      Participants
    title
    Platelets ≥ 700 × 10^9/L
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        240
      units
      Participants
    title
    Leukocytes ≤ 2.8 × 10^9/L
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        240
      units
      Participants
    title
    Leukocytes ≥ 16.0 × 10^9/L
denoms
  1. counts
    1. group Id
      OG000
      value
      240
    units
    Participants
description
The number of patients with each type of event is summarized.
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 and who had a post-baseline laboratory value, except for hemoglobin, which required non-missing laboratory values at baseline and post-baseline.
reporting Status
POSTED
time Frame
6 months
title
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice