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NCT00334282 · OUTCOME

Adjusted Mean Change From Baseline in the Index 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), through application of societal weights, and a VAS score (VAS). Index is interpreted on a continuum from 1.0 (best possible health) to 0 (represents dead), to some health sates being worse than dead (\<0).

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 mg253
Placebo125

Reported measurements

Week 6, n=253, 125
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg-0.0140.2203Not reportedNot reportedNot reported
Placebo-0.0290.2674Not reportedNot reportedNot reported
Week 12, n=219, 86
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg-0.0400.2148Not reportedNot reportedNot reported
Placebo0.0070.1969Not reportedNot reportedNot reported
Week 18, n=196, 62
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg-0.0230.2305Not reportedNot reportedNot reported
Placebo-0.0060.1466Not reportedNot reportedNot reported
Week 24, n=166, 51
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg-0.0250.2420Not reportedNot reportedNot reported
Placebo-0.0010.2411Not reportedNot reportedNot reported
Week 36, n=98, 24
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.0300.1961Not reportedNot reportedNot reported
Placebo-0.0050.2015Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.2203
        value
        -0.014
      2. group Id
        OG001
        spread
        0.2674
        value
        -0.029
    title
    Week 6, n=253, 125
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.2148
        value
        -0.040
      2. group Id
        OG001
        spread
        0.1969
        value
        0.007
    title
    Week 12, n=219, 86
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.2305
        value
        -0.023
      2. group Id
        OG001
        spread
        0.1466
        value
        -0.006
    title
    Week 18, n=196, 62
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.2420
        value
        -0.025
      2. group Id
        OG001
        spread
        0.2411
        value
        -0.001
    title
    Week 24, n=166, 51
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1961
        value
        0.030
      2. group Id
        OG001
        spread
        0.2015
        value
        -0.005
    title
    Week 36, n=98, 24
denoms
  1. counts
    1. group Id
      OG000
      value
      253
    2. group Id
      OG001
      value
      125
    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), through application of societal weights, and a VAS score (VAS). Index is interpreted on a continuum from 1.0 (best possible health) to 0 (represents dead), to some health sates being worse than dead (\<0).
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 Index 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