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NCT00334282 · OUTCOME

Adjusted Mean Change From Baseline in the Visual Analog Scale (VAS) Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48

Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma · Source last updated 2016-02-05

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

Measure
MEAN
Unit
points on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline and Weeks 6, 12, 18, 24, and 48

What was measured

The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index) and a VAS score (VAS), obtained from participant's self-reports of their health on a VAS thermometer scale. The EQ-5D VAS ranges from 0% (worst imaginable health state) to 100% (best imaginable health state).

Analysis population: Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-Baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.

Groups in this outcome

Pazopanib 800 mg

Pazopanib 800 mg (tablets) administered orally once a day

Placebo

Matching placebo administered orally once a day

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

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg239
Placebo111

Reported measurements

Week 12, n=212, 80
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg-0.921.07Not reportedNot reportedNot reported
Placebo-3.623.04Not reportedNot reportedNot reported
Week 6, n=239, 111
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.422.55Not reportedNot reportedNot reported
Placebo0.225.35Not reportedNot reportedNot reported
Week 18, n=189, 60
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.123.20Not reportedNot reportedNot reported
Placebo0.119.35Not reportedNot reportedNot reported
Week 24, n=161, 49
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg2.622.16Not reportedNot reportedNot reported
Placebo5.421.27Not reportedNot reportedNot reported
Week 36, n=95, 23
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg2.424.21Not reportedNot reportedNot reported
Placebo8.823.96Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.07
        value
        -0.9
      2. group Id
        OG001
        spread
        23.04
        value
        -3.6
    title
    Week 12, n=212, 80
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.55
        value
        0.4
      2. group Id
        OG001
        spread
        25.35
        value
        0.2
    title
    Week 6, n=239, 111
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.20
        value
        0.1
      2. group Id
        OG001
        spread
        19.35
        value
        0.1
    title
    Week 18, n=189, 60
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.16
        value
        2.6
      2. group Id
        OG001
        spread
        21.27
        value
        5.4
    title
    Week 24, n=161, 49
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.21
        value
        2.4
      2. group Id
        OG001
        spread
        23.96
        value
        8.8
    title
    Week 36, n=95, 23
denoms
  1. counts
    1. group Id
      OG000
      value
      239
    2. group Id
      OG001
      value
      111
    units
    Participants
description
The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index) and a VAS score (VAS), obtained from participant's self-reports of their health on a VAS thermometer scale. The EQ-5D VAS ranges from 0% (worst imaginable health state) to 100% (best imaginable health state).
dispersion Type
Standard Deviation
groups
  1. description
    Pazopanib 800 mg (tablets) administered orally once a day
    id
    OG000
    title
    Pazopanib 800 mg
  2. description
    Matching placebo administered orally once a day
    id
    OG001
    title
    Placebo
param Type
MEAN
population Description
Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-Baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.
reporting Status
POSTED
time Frame
Baseline and Weeks 6, 12, 18, 24, and 48
title
Adjusted Mean Change From Baseline in the Visual Analog Scale (VAS) Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48
type
SECONDARY
unit Of Measure
points on a scale

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Preserved source evidence · Not medical advice