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NCT02773849 · OUTCOME

Anti-adenoviral Antibody Levels for Correlation to Response Rate

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
12 Months

What was measured

Measurement of anti-adenoviral antibody levels at each dosing period, withdrawal, and at 12 months were done. A patient was considered to have a positive immunogenic response in anti-adenoviral antibodies if a post-baseline titration demonstrated a greater than a 2-fold dilution increase from baseline. The table represent data at any time during the 12 months period, which means that the patients were included in the Yes group if they at any measurement during the trial had a 2-fold dilution increase from baseline.

Analysis population: Patients with Positive Immunogenic Response in Anti-Adenoviral Antibodies at Post-Baseline based on patients who had achieved High-Grade Recurrence Free Survival at 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 Situ89
Papillary Disease45
Total134

Reported measurements

Yes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carcinoma in Situ63Not reportedNot reportedNot reportedNot reported
Papillary Disease34Not reportedNot reportedNot reportedNot reported
Total97Not reportedNot reportedNot reportedNot reported
No
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carcinoma in Situ26Not reportedNot reportedNot reportedNot reported
Papillary Disease11Not reportedNot reportedNot reportedNot reported
Total37Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        63
      2. group Id
        OG001
        value
        34
      3. group Id
        OG002
        value
        97
    title
    Yes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        37
    title
    No
denoms
  1. counts
    1. group Id
      OG000
      value
      89
    2. group Id
      OG001
      value
      45
    3. group Id
      OG002
      value
      134
    units
    Participants
description
Measurement of anti-adenoviral antibody levels at each dosing period, withdrawal, and at 12 months were done. A patient was considered to have a positive immunogenic response in anti-adenoviral antibodies if a post-baseline titration demonstrated a greater than a 2-fold dilution increase from baseline. The table represent data at any time during the 12 months period, which means that the patients were included in the Yes group if they at any measurement during the trial had a 2-fold dilution increase from baseline.
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
Patients with Positive Immunogenic Response in Anti-Adenoviral Antibodies at Post-Baseline based on patients who had achieved High-Grade Recurrence Free Survival at 12 months
reporting Status
POSTED
time Frame
12 Months
title
Anti-adenoviral Antibody Levels for Correlation to Response Rate
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice