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NCT02773849 · OUTCOME

Safety of ADSTILADRIN

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 type, incidence, relatedness and severity of treatment emergent adverse events of ADSTILADRIN as assessed by NCI-CTCAE V4.03 were monitored.

Analysis population: Safety Analysis Set

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

TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carcinoma in Situ101Not reportedNot reportedNot reportedNot reported
Papillary Disease45Not reportedNot reportedNot reportedNot reported
Total146Not reportedNot reportedNot reportedNot reported
Serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carcinoma in Situ10Not reportedNot reportedNot reportedNot reported
Papillary Disease9Not reportedNot reportedNot reportedNot reported
Total19Not reportedNot reportedNot reportedNot reported
NCI-CTCAE Grade 3/4/5 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carcinoma in Situ22Not reportedNot reportedNot reportedNot reported
Papillary Disease12Not reportedNot reportedNot reportedNot reported
Total34Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        101
      2. group Id
        OG001
        value
        45
      3. group Id
        OG002
        value
        146
    title
    TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        19
    title
    Serious TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        34
    title
    NCI-CTCAE Grade 3/4/5 TEAE
denoms
  1. counts
    1. group Id
      OG000
      value
      107
    2. group Id
      OG001
      value
      50
    3. group Id
      OG002
      value
      157
    units
    Participants
description
The type, incidence, relatedness and severity of treatment emergent adverse events of ADSTILADRIN as assessed by NCI-CTCAE V4.03 were monitored.
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
Safety Analysis Set
reporting Status
POSTED
time Frame
60 Months
title
Safety of ADSTILADRIN
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice