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NCT04995419 · OUTCOME

Number of Participants With Antitherapeutic Antibodies (ATA)

A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy · Source last updated 2025-10-07

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
From first dose until 9.33 months

What was measured

Number of participants with ATA were reported.

Analysis population: FAS population with available data were analyzed.

Groups in this outcome

Enfortumab Vedotin 1.25 mg/kg

Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin 1.25 mg/kg38

Reported measurements

Source class 1

Baseline Negative, Negative post-baseline

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg37Not reportedNot reportedNot reportedNot reported

Baseline Negative, Positive post-baseline

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg0Not reportedNot reportedNot reportedNot reported

Baseline Positive, Negative post-baseline

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg1Not reportedNot reportedNot reportedNot reported

Baseline Positive, Positive post-baseline

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        37
      title
      Baseline Negative, Negative post-baseline
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Baseline Negative, Positive post-baseline
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Baseline Positive, Negative post-baseline
    4. measurements
      1. group Id
        OG000
        value
        0
      title
      Baseline Positive, Positive post-baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    units
    Participants
description
Number of participants with ATA were reported.
groups
  1. description
    Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
    id
    OG000
    title
    Enfortumab Vedotin 1.25 mg/kg
param Type
COUNT_OF_PARTICIPANTS
population Description
FAS population with available data were analyzed.
reporting Status
POSTED
time Frame
From first dose until 9.33 months
title
Number of Participants With Antitherapeutic Antibodies (ATA)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice