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NCT02773849 · OUTCOME

Incidence of Cystectomy at 12 Months, 2 Years and 5 Years

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
60 Months

What was measured

The incidence of cystectomy is described as the proportion of patients undergoing radical cystectomy for any reason after the first dose, within 12 months, 2 years and 5 years.

Analysis population: Proportion of patients undergoing cystectomy within 5 years, 2 years and 12 months

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

12 months
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carcinoma in Situ27Not reportedNot reportedNot reportedNot reported
Papillary Disease7Not reportedNot reportedNot reportedNot reported
Total34Not reportedNot reportedNot reportedNot reported
2 years
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carcinoma in Situ35Not reportedNot reportedNot reportedNot reported
Papillary Disease10Not reportedNot reportedNot reportedNot reported
Total45Not reportedNot reportedNot reportedNot reported
5 years
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carcinoma in Situ42Not reportedNot reportedNot reportedNot reported
Papillary Disease14Not reportedNot reportedNot reportedNot reported
Total56Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        34
    title
    12 months
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        45
    title
    2 years
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        56
    title
    5 years
denoms
  1. counts
    1. group Id
      OG000
      value
      103
    2. group Id
      OG001
      value
      48
    3. group Id
      OG002
      value
      151
    units
    Participants
description
The incidence of cystectomy is described as the proportion of patients undergoing radical cystectomy for any reason after the first dose, within 12 months, 2 years and 5 years.
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
COUNT_OF_PARTICIPANTS
population Description
Proportion of patients undergoing cystectomy within 5 years, 2 years and 12 months
reporting Status
POSTED
time Frame
60 Months
title
Incidence of Cystectomy at 12 Months, 2 Years and 5 Years
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice