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NCT02426125 · OUTCOME

Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)

A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer · Source last updated 2023-08-21

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

Measure
MEAN
Unit
millimeter (mm)
Interval / dispersion
Standard Deviation
Time frame
Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)

What was measured

The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions. Participants indicated their current health status by marking on a VAS ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).

Analysis population: All randomized participants with baseline and 30-day follow-up data.

Groups in this outcome

Ramucirumab + Docetaxel

Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Placebo + Docetaxel

Placebo IV plus docetaxel (75 mg/m²) IV ion day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

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

Analysis denominator · Participants

GroupSource count
Ramucirumab + Docetaxel86
Placebo + Docetaxel105

Reported measurements

Source class 1
Values in millimeter (mm) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab + Docetaxel-7.8717.95Not reportedNot reportedNot reported
Placebo + Docetaxel-10.9116.77Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.95
        value
        -7.87
      2. group Id
        OG001
        spread
        16.77
        value
        -10.91
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    2. group Id
      OG001
      value
      105
    units
    Participants
description
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions. Participants indicated their current health status by marking on a VAS ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).
dispersion Type
Standard Deviation
groups
  1. description
    Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    id
    OG000
    title
    Ramucirumab + Docetaxel
  2. description
    Placebo IV plus docetaxel (75 mg/m²) IV ion day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    id
    OG001
    title
    Placebo + Docetaxel
param Type
MEAN
population Description
All randomized participants with baseline and 30-day follow-up data.
reporting Status
POSTED
time Frame
Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
title
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)
type
SECONDARY
unit Of Measure
millimeter (mm)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice