Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02773849 · OUTCOME

Durability of High-grade-recurrence-free Survival in Patients With High-grade Ta or T1 Papillary Disease (With or 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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 57 months

What was measured

HGRF survival was defined as the time from the first dose to the first recurrence of high-grade disease (including muscle-invasive disease progression and death due to any cause). Patients without high-grade disease recurrence were censored at the last disease assessment not showing high-grade disease recurrence.

Analysis population: Patients with no recurrence of high-grade disease

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 Situ103
Papillary Disease48
Total151

Reported measurements

HGRF Survival
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carcinoma in Situ5.95Not reported3.388.31Not reported
Papillary Disease12.35Not reported6.6720.27Not reported
Total7.31Not reported5.6811.93Not reported
Probability of duration of HGRF survival for 57 months
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carcinoma in Situ13.2Not reported6.921.5Not reported
Papillary Disease32.7Not reported19.546.6Not reported
Total19.0Not reported12.626.4Not reported
Probability of duration of HGRF survival for 48 months
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carcinoma in Situ16.7Not reported10.124.9Not reported
Papillary Disease32.7Not reported19.546.6Not reported
Total21.6Not reported15.228.8Not reported
Probability of duration of HGRF survival for 36 months
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carcinoma in Situ19.3Not reported12.227.6Not reported
Papillary Disease32.7Not reported19.546.6Not reported
Total23.6Not reported17.030.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.38
        upper Limit
        8.31
        value
        5.95
      2. group Id
        OG001
        lower Limit
        6.67
        upper Limit
        20.27
        value
        12.35
      3. group Id
        OG002
        lower Limit
        5.68
        upper Limit
        11.93
        value
        7.31
    title
    HGRF Survival
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.9
        upper Limit
        21.5
        value
        13.2
      2. group Id
        OG001
        lower Limit
        19.5
        upper Limit
        46.6
        value
        32.7
      3. group Id
        OG002
        lower Limit
        12.6
        upper Limit
        26.4
        value
        19.0
    title
    Probability of duration of HGRF survival for 57 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.1
        upper Limit
        24.9
        value
        16.7
      2. group Id
        OG001
        lower Limit
        19.5
        upper Limit
        46.6
        value
        32.7
      3. group Id
        OG002
        lower Limit
        15.2
        upper Limit
        28.8
        value
        21.6
    title
    Probability of duration of HGRF survival for 48 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.2
        upper Limit
        27.6
        value
        19.3
      2. group Id
        OG001
        lower Limit
        19.5
        upper Limit
        46.6
        value
        32.7
      3. group Id
        OG002
        lower Limit
        17.0
        upper Limit
        30.8
        value
        23.6
    title
    Probability of duration of HGRF survival for 36 months
denoms
  1. counts
    1. group Id
      OG000
      value
      103
    2. group Id
      OG001
      value
      48
    3. group Id
      OG002
      value
      151
    units
    Participants
description
HGRF survival was defined as the time from the first dose to the first recurrence of high-grade disease (including muscle-invasive disease progression and death due to any cause). Patients without high-grade disease recurrence were censored at the last disease assessment not showing high-grade disease recurrence.
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
population Description
Patients with no recurrence of high-grade disease
reporting Status
POSTED
time Frame
Up to 57 months
title
Durability of High-grade-recurrence-free Survival in Patients With High-grade Ta or T1 Papillary Disease (With or Without Concomitant CIS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice