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NCT00375674 · OUTCOME

PROs- EORTC QLQ-C30: Symptom Scale Scores Between Treatment Comparison

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer · Source last updated 2018-09-21

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

Measure
MEAN
Unit
Scores on scale
Interval / dispersion
95% Confidence Interval
Time frame
Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)

What was measured

PROs assessed health-related QoL by using the EORTC QLQ-C30, which was a 30 multi-item symptom scales (fatigue, nausea/vomiting, \& pain), and 6 single item symptom scales for other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, \& the financial impact of cancer). The questionnaire includes 28 items with 4-point Likert type responses from "not at all" to "very much" to assess symptoms. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented more severe symptoms.

Analysis population: ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.

Groups in this outcome

Sunitinib

Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.

Placebo

Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.

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

Analysis denominator · Participants

GroupSource count
Sunitinib309
Placebo306

Reported measurements

Fatigue
Values in Scores on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sunitinib29.94Not reported28.3331.56Not reported
Placebo21.74Not reported20.1623.31Not reported
Nausea and Vomiting
Values in Scores on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sunitinib7.35Not reported6.388.33Not reported
Placebo3.46Not reported2.514.41Not reported
Pain
Values in Scores on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sunitinib21.81Not reported20.1023.52Not reported
Placebo16.63Not reported14.9618.30Not reported
Dyspnoea
Values in Scores on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sunitinib14.97Not reported13.3816.57Not reported
Placebo11.89Not reported10.3313.45Not reported
Insomnia
Values in Scores on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sunitinib22.22Not reported20.2624.19Not reported
Placebo20.73Not reported18.8122.65Not reported
Appetite Loss
Values in Scores on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sunitinib14.66Not reported13.1216.21Not reported
Placebo4.62Not reported3.116.13Not reported
Constipation
Values in Scores on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sunitinib11.24Not reported9.6612.82Not reported
Placebo9.83Not reported8.2911.37Not reported
Diarrhoea
Values in Scores on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sunitinib19.25Not reported17.5420.95Not reported
Placebo7.25Not reported5.598.91Not reported
Financial Difficulties
Values in Scores on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sunitinib15.12Not reported13.4216.82Not reported
Placebo13.92Not reported12.2615.59Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.33
        upper Limit
        31.56
        value
        29.94
      2. group Id
        OG001
        lower Limit
        20.16
        upper Limit
        23.31
        value
        21.74
    title
    Fatigue
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.38
        upper Limit
        8.33
        value
        7.35
      2. group Id
        OG001
        lower Limit
        2.51
        upper Limit
        4.41
        value
        3.46
    title
    Nausea and Vomiting
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.10
        upper Limit
        23.52
        value
        21.81
      2. group Id
        OG001
        lower Limit
        14.96
        upper Limit
        18.30
        value
        16.63
    title
    Pain
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.38
        upper Limit
        16.57
        value
        14.97
      2. group Id
        OG001
        lower Limit
        10.33
        upper Limit
        13.45
        value
        11.89
    title
    Dyspnoea
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.26
        upper Limit
        24.19
        value
        22.22
      2. group Id
        OG001
        lower Limit
        18.81
        upper Limit
        22.65
        value
        20.73
    title
    Insomnia
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.12
        upper Limit
        16.21
        value
        14.66
      2. group Id
        OG001
        lower Limit
        3.11
        upper Limit
        6.13
        value
        4.62
    title
    Appetite Loss
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.66
        upper Limit
        12.82
        value
        11.24
      2. group Id
        OG001
        lower Limit
        8.29
        upper Limit
        11.37
        value
        9.83
    title
    Constipation
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.54
        upper Limit
        20.95
        value
        19.25
      2. group Id
        OG001
        lower Limit
        5.59
        upper Limit
        8.91
        value
        7.25
    title
    Diarrhoea
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.42
        upper Limit
        16.82
        value
        15.12
      2. group Id
        OG001
        lower Limit
        12.26
        upper Limit
        15.59
        value
        13.92
    title
    Financial Difficulties
denoms
  1. counts
    1. group Id
      OG000
      value
      309
    2. group Id
      OG001
      value
      306
    units
    Participants
description
PROs assessed health-related QoL by using the EORTC QLQ-C30, which was a 30 multi-item symptom scales (fatigue, nausea/vomiting, \& pain), and 6 single item symptom scales for other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, \& the financial impact of cancer). The questionnaire includes 28 items with 4-point Likert type responses from "not at all" to "very much" to assess symptoms. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented more severe symptoms.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
    id
    OG000
    title
    Sunitinib
  2. description
    Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
    id
    OG001
    title
    Placebo
param Type
MEAN
population Description
ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
reporting Status
POSTED
time Frame
Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
title
PROs- EORTC QLQ-C30: Symptom Scale Scores Between Treatment Comparison
type
SECONDARY
unit Of Measure
Scores on scale

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Preserved source evidence · Not medical advice