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NCT02773849 · OUTCOME

Rate of Event-free Survival, Where Event-free Survival is Defined as High-grade Recurrence Free (HGRF) Survival in Patients With High-grade Ta or T1 Disease (Without Concomitant CIS)

ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) · Source last updated 2024-07-29

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 57 months

What was measured

Complete response rate will be measured by determining the number of patients without recurrence of high-grade disease using results from urine cytology, cystoscopy, and biopsy of the bladder. Incidence of HGRF survival at Months 3, 6, 9, and 12, and every 3 months up to Month 24, and then at Months 36, 48, and 57.

Analysis population: A patient was judged to have achieved HGRF survival at a time point (eg, Months 3, 6, 9, and 12) if the patient was alive and without documented recurrence of high-grade disease or muscle-invasive disease progression as assessed by the Investigator at that time point.

Groups in this outcome

Papillary Disease

Patients with high-grade Ta or T1 papillary disease (without concomitant CIS)

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

Analysis denominator · Participants

GroupSource count
Papillary Disease48

Reported measurements

Month 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Papillary Disease35Not reportedNot reportedNot reportedNot reported
Month 6
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Papillary Disease30Not reportedNot reportedNot reportedNot reported
Month 9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Papillary Disease28Not reportedNot reportedNot reportedNot reported
Month 12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Papillary Disease21Not reportedNot reportedNot reportedNot reported
Month 24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Papillary Disease16Not reportedNot reportedNot reportedNot reported
Month 36
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Papillary Disease11Not reportedNot reportedNot reportedNot reported
Month 48
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Papillary Disease7Not reportedNot reportedNot reportedNot reported
Month 57
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Papillary Disease7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        35
    title
    Month 3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        30
    title
    Month 6
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        28
    title
    Month 9
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    title
    Month 12
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    Month 24
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Month 36
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Month 48
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Month 57
denoms
  1. counts
    1. group Id
      OG000
      value
      48
    units
    Participants
description
Complete response rate will be measured by determining the number of patients without recurrence of high-grade disease using results from urine cytology, cystoscopy, and biopsy of the bladder. Incidence of HGRF survival at Months 3, 6, 9, and 12, and every 3 months up to Month 24, and then at Months 36, 48, and 57.
groups
  1. description
    Patients with high-grade Ta or T1 papillary disease (without concomitant CIS)
    id
    OG000
    title
    Papillary Disease
param Type
COUNT_OF_PARTICIPANTS
population Description
A patient was judged to have achieved HGRF survival at a time point (eg, Months 3, 6, 9, and 12) if the patient was alive and without documented recurrence of high-grade disease or muscle-invasive disease progression as assessed by the Investigator at that time point.
reporting Status
POSTED
time Frame
up to 57 months
title
Rate of Event-free Survival, Where Event-free Survival is Defined as High-grade Recurrence Free (HGRF) Survival in Patients With High-grade Ta or T1 Disease (Without Concomitant CIS)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice