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NCT04995419 · OUTCOME

Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

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
End of Treatment (Baseline up to 9.33 months)

What was measured

ECOG performance status was measured on an 6 point scale. 0-Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. Dead. Number of participants with ECOG PS was reported."

Analysis population: SAF population

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/kg40

Reported measurements

ECOG PS= 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg2Not reportedNot reportedNot reportedNot reported
ECOG PS= 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg8Not reportedNot reportedNot reportedNot reported
ECOG PS= 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg1Not reportedNot reportedNot reportedNot reported
ECOG PS= 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg1Not reportedNot reportedNot reportedNot reported
ECOG PS= 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg0Not reportedNot reportedNot reportedNot reported
ECOG PS= 5
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
        2
    title
    ECOG PS= 0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    ECOG PS= 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    ECOG PS= 2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    ECOG PS= 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    ECOG PS= 4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    ECOG PS= 5
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
ECOG performance status was measured on an 6 point scale. 0-Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. Dead. Number of participants with ECOG PS was 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
SAF population
reporting Status
POSTED
time Frame
End of Treatment (Baseline up to 9.33 months)
title
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice