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NCT00720941 · OUTCOME

Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4

Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma · Source last updated 2025-03-30

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

Measure
MEAN
Unit
Scores on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)

What was measured

The SQLQ scale consists of 5 items that assess the worst mouth and throat, hand, and foot soreness, as well as limitations due to mouth/throat and foot soreness. Participants were asked to assess their worst mouth/throat, hand, and foot soreness by answering the question of " In the past 4 weeks, what was your worst mouth/throat, hand, and foot soreness?" by using the following 4-point scale: 0, I never had any soreness; 1, I had a little bit of soreness; 2, I had quite a lot of soreness; 3, I had severe soreness. A positive mean change from Baseline represents a worsening of condition.

Analysis population: Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.

Groups in this outcome

Pazopanib 800 mg

Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Sunitinib 50 mg

Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

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 mg202
Sunitinib 50 mg184

Reported measurements

Mouth and Throat Soreness, Week 4 (n=202,180)

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg202
Sunitinib 50 mg180
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.40.87Not reportedNot reportedNot reported
Sunitinib 50 mg1.00.99Not reportedNot reportedNot reported
Mouth and Throat Soreness, Week 10 (n=164,155)

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg164
Sunitinib 50 mg155
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.40.88Not reportedNot reportedNot reported
Sunitinib 50 mg0.90.99Not reportedNot reportedNot reported
Mouth and Throat Soreness, Week 16 (n=137,138)

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg137
Sunitinib 50 mg138
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.30.73Not reportedNot reportedNot reported
Sunitinib 50 mg0.80.89Not reportedNot reportedNot reported
Mouth and Throat Soreness, Week 22 (n=120,117)

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg120
Sunitinib 50 mg117
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.20.75Not reportedNot reportedNot reported
Sunitinib 50 mg0.80.81Not reportedNot reportedNot reported
Hand Soreness, Week 4 (n=200,184)

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg200
Sunitinib 50 mg184
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.20.71Not reportedNot reportedNot reported
Sunitinib 50 mg0.30.72Not reportedNot reportedNot reported
Hand Soreness, Week 10 (n=164,153)

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg164
Sunitinib 50 mg153
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.30.84Not reportedNot reportedNot reported
Sunitinib 50 mg0.70.85Not reportedNot reportedNot reported
Hand Soreness, Week 16 (n=139,136)

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg139
Sunitinib 50 mg136
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.40.76Not reportedNot reportedNot reported
Sunitinib 50 mg0.60.80Not reportedNot reportedNot reported
Hand Soreness, Week 22 (n=123,115)

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg123
Sunitinib 50 mg115
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.30.69Not reportedNot reportedNot reported
Sunitinib 50 mg0.60.82Not reportedNot reportedNot reported
Foot Soreness, Week 4 (n=199,182)

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg199
Sunitinib 50 mg182
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.20.86Not reportedNot reportedNot reported
Sunitinib 50 mg0.40.80Not reportedNot reportedNot reported
Foot Soreness, Week 10 (n=163,153)

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg163
Sunitinib 50 mg153
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.31.00Not reportedNot reportedNot reported
Sunitinib 50 mg0.60.99Not reportedNot reportedNot reported
Foot Soreness, Week 16 (n=140,136)

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg140
Sunitinib 50 mg136
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.31.07Not reportedNot reportedNot reported
Sunitinib 50 mg0.80.99Not reportedNot reportedNot reported
Foot Soreness, Week 22 (n=123,116)

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg123
Sunitinib 50 mg116
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg0.31.04Not reportedNot reportedNot reported
Sunitinib 50 mg0.90.96Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.87
        value
        0.4
      2. group Id
        OG001
        spread
        0.99
        value
        1.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        202
      2. group Id
        OG001
        value
        180
      units
      Participants
    title
    Mouth and Throat Soreness, Week 4 (n=202,180)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.88
        value
        0.4
      2. group Id
        OG001
        spread
        0.99
        value
        0.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        164
      2. group Id
        OG001
        value
        155
      units
      Participants
    title
    Mouth and Throat Soreness, Week 10 (n=164,155)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.73
        value
        0.3
      2. group Id
        OG001
        spread
        0.89
        value
        0.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        137
      2. group Id
        OG001
        value
        138
      units
      Participants
    title
    Mouth and Throat Soreness, Week 16 (n=137,138)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.75
        value
        0.2
      2. group Id
        OG001
        spread
        0.81
        value
        0.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        120
      2. group Id
        OG001
        value
        117
      units
      Participants
    title
    Mouth and Throat Soreness, Week 22 (n=120,117)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.71
        value
        0.2
      2. group Id
        OG001
        spread
        0.72
        value
        0.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        200
      2. group Id
        OG001
        value
        184
      units
      Participants
    title
    Hand Soreness, Week 4 (n=200,184)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.84
        value
        0.3
      2. group Id
        OG001
        spread
        0.85
        value
        0.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        164
      2. group Id
        OG001
        value
        153
      units
      Participants
    title
    Hand Soreness, Week 10 (n=164,153)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.76
        value
        0.4
      2. group Id
        OG001
        spread
        0.80
        value
        0.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        139
      2. group Id
        OG001
        value
        136
      units
      Participants
    title
    Hand Soreness, Week 16 (n=139,136)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.69
        value
        0.3
      2. group Id
        OG001
        spread
        0.82
        value
        0.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        123
      2. group Id
        OG001
        value
        115
      units
      Participants
    title
    Hand Soreness, Week 22 (n=123,115)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.86
        value
        0.2
      2. group Id
        OG001
        spread
        0.80
        value
        0.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        199
      2. group Id
        OG001
        value
        182
      units
      Participants
    title
    Foot Soreness, Week 4 (n=199,182)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.00
        value
        0.3
      2. group Id
        OG001
        spread
        0.99
        value
        0.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        163
      2. group Id
        OG001
        value
        153
      units
      Participants
    title
    Foot Soreness, Week 10 (n=163,153)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.07
        value
        0.3
      2. group Id
        OG001
        spread
        0.99
        value
        0.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        140
      2. group Id
        OG001
        value
        136
      units
      Participants
    title
    Foot Soreness, Week 16 (n=140,136)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.04
        value
        0.3
      2. group Id
        OG001
        spread
        0.96
        value
        0.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        123
      2. group Id
        OG001
        value
        116
      units
      Participants
    title
    Foot Soreness, Week 22 (n=123,116)
denoms
  1. counts
    1. group Id
      OG000
      value
      202
    2. group Id
      OG001
      value
      184
    units
    Participants
description
The SQLQ scale consists of 5 items that assess the worst mouth and throat, hand, and foot soreness, as well as limitations due to mouth/throat and foot soreness. Participants were asked to assess their worst mouth/throat, hand, and foot soreness by answering the question of " In the past 4 weeks, what was your worst mouth/throat, hand, and foot soreness?" by using the following 4-point scale: 0, I never had any soreness; 1, I had a little bit of soreness; 2, I had quite a lot of soreness; 3, I had severe soreness. A positive mean change from Baseline represents a worsening of condition.
dispersion Type
Standard Deviation
groups
  1. description
    Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
    id
    OG000
    title
    Pazopanib 800 mg
  2. description
    Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
    id
    OG001
    title
    Sunitinib 50 mg
param Type
MEAN
population Description
Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.
reporting Status
POSTED
time Frame
Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
title
Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4
type
SECONDARY
unit Of Measure
Scores on a scale

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Preserved source evidence · Not medical advice