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NCT00334282 · OUTCOME

Adjusted Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ C-30) Score 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 EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer participants. The analyses for EORTC QLQ-C30 were focused on global health status/Health-Related Quality of Life (HRQOL) scores on the questionnaire. The scores (from 1 \[very poor quality of life\] to 7 \[excellent quality of life\]) for these two questions were averaged and then transformed to a 0 - 100 scale (based on published methods) prior to analysis of change from Baseline.

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

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
Pazopanib246
Placebo111

Reported measurements

Week 6, n=243, 110
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib-3.219.66Not reportedNot reportedNot reported
Placebo-2.619.18Not reportedNot reportedNot reported
Week 12, n=219, 81
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib-3.620.16Not reportedNot reportedNot reported
Placebo-0.517.55Not reportedNot reportedNot reported
Week 18, n=191, 61
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib-2.521.70Not reportedNot reportedNot reported
Placebo-0.318.13Not reportedNot reportedNot reported
Week 24, n=164, 49
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib0.119.81Not reportedNot reportedNot reported
Placebo-0.518.67Not reportedNot reportedNot reported
Week 48, n=96, 24
Values in points on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib-0.318.36Not reportedNot reportedNot reported
Placebo0.315.63Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.66
        value
        -3.2
      2. group Id
        OG001
        spread
        19.18
        value
        -2.6
    title
    Week 6, n=243, 110
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.16
        value
        -3.6
      2. group Id
        OG001
        spread
        17.55
        value
        -0.5
    title
    Week 12, n=219, 81
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.70
        value
        -2.5
      2. group Id
        OG001
        spread
        18.13
        value
        -0.3
    title
    Week 18, n=191, 61
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.81
        value
        0.1
      2. group Id
        OG001
        spread
        18.67
        value
        -0.5
    title
    Week 24, n=164, 49
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.36
        value
        -0.3
      2. group Id
        OG001
        spread
        15.63
        value
        0.3
    title
    Week 48, n=96, 24
denoms
  1. counts
    1. group Id
      OG000
      value
      246
    2. group Id
      OG001
      value
      111
    units
    Participants
description
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer participants. The analyses for EORTC QLQ-C30 were focused on global health status/Health-Related Quality of Life (HRQOL) scores on the questionnaire. The scores (from 1 \[very poor quality of life\] to 7 \[excellent quality of life\]) for these two questions were averaged and then transformed to a 0 - 100 scale (based on published methods) prior to analysis of change from Baseline.
dispersion Type
Standard Deviation
groups
  1. description
    Pazopanib 800 mg (tablets) administered orally once a day
    id
    OG000
    title
    Pazopanib
  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 European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ C-30) Score 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