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NCT03219333 · OUTCOME

Overall Survival (OS): Final Analysis

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer · Source last updated 2024-08-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Cohort 1: median follow-up: 61.0 months (range 59.63, 62.36); Cohort 2: median follow-up time: 45.8 months (range 44.91 to 48.95)

What was measured

OS is defined as the time from first dose of enfortumab vedotin to death from any cause.

Analysis population: Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.

Groups in this outcome

Enfortumab Vedotin - Cohort 1

Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

Enfortumab Vedotin - Cohort 2

Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

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 - Cohort 1125
Enfortumab Vedotin - Cohort 289

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 112.4Not reported9.4615.57Not reported
Enfortumab Vedotin - Cohort 215.6Not reported11.2420.37Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.46
        upper Limit
        15.57
        value
        12.4
      2. group Id
        OG001
        lower Limit
        11.24
        upper Limit
        20.37
        value
        15.6
denoms
  1. counts
    1. group Id
      OG000
      value
      125
    2. group Id
      OG001
      value
      89
    units
    Participants
description
OS is defined as the time from first dose of enfortumab vedotin to death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
    id
    OG000
    title
    Enfortumab Vedotin - Cohort 1
  2. description
    Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
    id
    OG001
    title
    Enfortumab Vedotin - Cohort 2
param Type
MEDIAN
population Description
Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
reporting Status
POSTED
time Frame
Cohort 1: median follow-up: 61.0 months (range 59.63, 62.36); Cohort 2: median follow-up time: 45.8 months (range 44.91 to 48.95)
title
Overall Survival (OS): Final Analysis
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice