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NCT02773849 · OUTCOME

Durability of Response During the Long-term Follow-up Period.

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 60 Months

What was measured

Durability 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 if clinically indicated.

Groups in this outcome

Carcinoma in Situ

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

Papillary Disease

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

Total

All patients

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

Analysis denominator · Participants

GroupSource count
Carcinoma in Situ107
Papillary Disease50
Total157

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carcinoma in Situ48.92Not reported37.8859.47Not reported
Papillary Disease59.01Not reported46.5560.52Not reported
Total50.83Not reported39.1060.02Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37.88
        upper Limit
        59.47
        value
        48.92
      2. group Id
        OG001
        lower Limit
        46.55
        upper Limit
        60.52
        value
        59.01
      3. group Id
        OG002
        lower Limit
        39.10
        upper Limit
        60.02
        value
        50.83
denoms
  1. counts
    1. group Id
      OG000
      value
      107
    2. group Id
      OG001
      value
      50
    3. group Id
      OG002
      value
      157
    units
    Participants
description
Durability 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 if clinically indicated.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with Carcinoma in situ (CIS) with or without concomitant high-grade Ta or T1 papillary disease
    id
    OG000
    title
    Carcinoma in Situ
  2. description
    Patients with high-grade Ta or T1 papillary disease (without concomitant CIS)
    id
    OG001
    title
    Papillary Disease
  3. description
    All patients
    id
    OG002
    title
    Total
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 60 Months
title
Durability of Response During the Long-term Follow-up Period.
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice