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NCT02773849 · OUTCOME

Overall Survival Rate in All Patients

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
NUMBER
Unit
percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
60 Months

What was measured

Overall survival rate was defined as the time from the first dose to death due to any cause. Patients who were still alive were censored at the last date the patient was known to be alive. Overall survival rate is a Kaplan-Meier estimate of the survivor function at each specific time point. The 95% CI is calculated using the Greenwood's formula with a log-log transformation. Percentage is calculated using the number of patients in the column heading as the denominator.

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

3 months
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carcinoma in Situ100Not reportedNANA95% confidence interval could not be calculated due to an insufficient number of participants with events
Papillary Disease100Not reportedNANA95% confidence interval could not be calculated due to an insufficient number of participants with events
Total100Not reportedNANA95% confidence interval could not be calculated due to an insufficient number of participants with events
6 months
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carcinoma in Situ99Not reported93.099.9Not reported
Papillary Disease100Not reportedNANA95% confidence interval could not be calculated due to an insufficient number of participants with events
Total99.3Not reported95.399.9Not reported
9 months
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carcinoma in Situ98Not reported92.299.5Not reported
Papillary Disease100Not reportedNANA95% confidence interval could not be calculated due to an insufficient number of participants with events
Total98.6Not reported94.799.7Not reported
12 months
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carcinoma in Situ98Not reported92.299.5Not reported
Papillary Disease97.9Not reported85.899.7Not reported
Total98Not reported93.899.3Not reported
24 months
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carcinoma in Situ94.9Not reported88.197.8Not reported
Papillary Disease93.5Not reported81.297.9Not reported
Total94.5Not reported89.297.2Not reported
48 months
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carcinoma in Situ83.6Not reported74.389.8Not reported
Papillary Disease88.9Not reported75.495.3Not reported
Total85.4Not reported78.390.3Not reported
60 months
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carcinoma in Situ76.3Not reported64.684.5Not reported
Papillary Disease85.9Not reported70.993.5Not reported
Total79.7Not reported71.086.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        95% confidence interval could not be calculated due to an insufficient number of participants with events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        100
      2. comment
        95% confidence interval could not be calculated due to an insufficient number of participants with events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        100
      3. comment
        95% confidence interval could not be calculated due to an insufficient number of participants with events
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        100
    title
    3 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        93.0
        upper Limit
        99.9
        value
        99
      2. comment
        95% confidence interval could not be calculated due to an insufficient number of participants with events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        100
      3. group Id
        OG002
        lower Limit
        95.3
        upper Limit
        99.9
        value
        99.3
    title
    6 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        92.2
        upper Limit
        99.5
        value
        98
      2. comment
        95% confidence interval could not be calculated due to an insufficient number of participants with events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        100
      3. group Id
        OG002
        lower Limit
        94.7
        upper Limit
        99.7
        value
        98.6
    title
    9 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        92.2
        upper Limit
        99.5
        value
        98
      2. group Id
        OG001
        lower Limit
        85.8
        upper Limit
        99.7
        value
        97.9
      3. group Id
        OG002
        lower Limit
        93.8
        upper Limit
        99.3
        value
        98
    title
    12 months
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        88.1
        upper Limit
        97.8
        value
        94.9
      2. group Id
        OG001
        lower Limit
        81.2
        upper Limit
        97.9
        value
        93.5
      3. group Id
        OG002
        lower Limit
        89.2
        upper Limit
        97.2
        value
        94.5
    title
    24 months
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.3
        upper Limit
        89.8
        value
        83.6
      2. group Id
        OG001
        lower Limit
        75.4
        upper Limit
        95.3
        value
        88.9
      3. group Id
        OG002
        lower Limit
        78.3
        upper Limit
        90.3
        value
        85.4
    title
    48 months
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        64.6
        upper Limit
        84.5
        value
        76.3
      2. group Id
        OG001
        lower Limit
        70.9
        upper Limit
        93.5
        value
        85.9
      3. group Id
        OG002
        lower Limit
        71.0
        upper Limit
        86.0
        value
        79.7
    title
    60 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
Overall survival rate was defined as the time from the first dose to death due to any cause. Patients who were still alive were censored at the last date the patient was known to be alive. Overall survival rate is a Kaplan-Meier estimate of the survivor function at each specific time point. The 95% CI is calculated using the Greenwood's formula with a log-log transformation. Percentage is calculated using the number of patients in the column heading as the denominator.
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
NUMBER
reporting Status
POSTED
time Frame
60 Months
title
Overall Survival Rate in All Patients
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice