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NCT00375674 · OUTCOME

PROs- EuroQoL EQ-5D Observed Means - Intent to Treat Population

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
Units on a scale
Interval / dispersion
Standard Error
Time frame
Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)

What was measured

Patient-reported outcomes (PROs) assessed health-related quality of life (QoL) by the EuroQoL Group health status questionnaire (EQ-5D), which was a brief self-administered, validated instrument with 2 parts. In this outcome measure, the first part with 5 descriptors of current health state (mobility, self-care, usual activities, pain/discomfort, \& anxiety/depression) was used; a participant was asked to rate each state on a 3-level scale (1=no problem, 2=some problem, \& 3=extreme problem); higher levels indicated greater severity/impairment. The published weights allowed the creation of a single summary score called the EQ-5D index, which ranged from -0.594 to 1; low scores represented a higher level of dysfunction \& 1 as perfect health.

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 a different drug from that to which they were randomized. Here, 'Number analyzed' signifies the number of participants evaluable at specified time-points.

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

Cycle 1 (Baseline)

Analysis denominator · Participants

GroupSource count
Sunitinib293
Placebo287
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib0.840.011Not reportedNot reportedNot reported
Placebo0.830.011Not reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
Sunitinib255
Placebo271
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib0.830.011Not reportedNot reportedNot reported
Placebo0.840.011Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
Sunitinib235
Placebo267
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib0.800.013Not reportedNot reportedNot reported
Placebo0.820.012Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
Sunitinib231
Placebo245
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib0.770.014Not reportedNot reportedNot reported
Placebo0.840.011Not reportedNot reportedNot reported
Cycle 5

Analysis denominator · Participants

GroupSource count
Sunitinib218
Placebo230
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib0.770.016Not reportedNot reportedNot reported
Placebo0.840.013Not reportedNot reportedNot reported
Cycle 6

Analysis denominator · Participants

GroupSource count
Sunitinib211
Placebo234
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib0.780.016Not reportedNot reportedNot reported
Placebo0.850.012Not reportedNot reportedNot reported
Cycle 7

Analysis denominator · Participants

GroupSource count
Sunitinib199
Placebo216
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib0.770.016Not reportedNot reportedNot reported
Placebo0.830.014Not reportedNot reportedNot reported
Cycle 8

Analysis denominator · Participants

GroupSource count
Sunitinib185
Placebo207
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib0.800.015Not reportedNot reportedNot reported
Placebo0.840.013Not reportedNot reportedNot reported
Cycle 9

Analysis denominator · Participants

GroupSource count
Sunitinib174
Placebo202
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib0.810.015Not reportedNot reportedNot reported
Placebo0.850.013Not reportedNot reportedNot reported
EOT

Analysis denominator · Participants

GroupSource count
Sunitinib250
Placebo245
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib0.750.017Not reportedNot reportedNot reported
Placebo0.830.015Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.011
        value
        0.84
      2. group Id
        OG001
        spread
        0.011
        value
        0.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        293
      2. group Id
        OG001
        value
        287
      units
      Participants
    title
    Cycle 1 (Baseline)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.011
        value
        0.83
      2. group Id
        OG001
        spread
        0.011
        value
        0.84
    denoms
    1. counts
      1. group Id
        OG000
        value
        255
      2. group Id
        OG001
        value
        271
      units
      Participants
    title
    Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.013
        value
        0.80
      2. group Id
        OG001
        spread
        0.012
        value
        0.82
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        267
      units
      Participants
    title
    Cycle 3
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.014
        value
        0.77
      2. group Id
        OG001
        spread
        0.011
        value
        0.84
    denoms
    1. counts
      1. group Id
        OG000
        value
        231
      2. group Id
        OG001
        value
        245
      units
      Participants
    title
    Cycle 4
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.016
        value
        0.77
      2. group Id
        OG001
        spread
        0.013
        value
        0.84
    denoms
    1. counts
      1. group Id
        OG000
        value
        218
      2. group Id
        OG001
        value
        230
      units
      Participants
    title
    Cycle 5
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.016
        value
        0.78
      2. group Id
        OG001
        spread
        0.012
        value
        0.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        211
      2. group Id
        OG001
        value
        234
      units
      Participants
    title
    Cycle 6
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.016
        value
        0.77
      2. group Id
        OG001
        spread
        0.014
        value
        0.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        199
      2. group Id
        OG001
        value
        216
      units
      Participants
    title
    Cycle 7
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.015
        value
        0.80
      2. group Id
        OG001
        spread
        0.013
        value
        0.84
    denoms
    1. counts
      1. group Id
        OG000
        value
        185
      2. group Id
        OG001
        value
        207
      units
      Participants
    title
    Cycle 8
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.015
        value
        0.81
      2. group Id
        OG001
        spread
        0.013
        value
        0.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        174
      2. group Id
        OG001
        value
        202
      units
      Participants
    title
    Cycle 9
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.017
        value
        0.75
      2. group Id
        OG001
        spread
        0.015
        value
        0.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        250
      2. group Id
        OG001
        value
        245
      units
      Participants
    title
    EOT
denoms
  1. counts
    1. group Id
      OG000
      value
      309
    2. group Id
      OG001
      value
      306
    units
    Participants
description
Patient-reported outcomes (PROs) assessed health-related quality of life (QoL) by the EuroQoL Group health status questionnaire (EQ-5D), which was a brief self-administered, validated instrument with 2 parts. In this outcome measure, the first part with 5 descriptors of current health state (mobility, self-care, usual activities, pain/discomfort, \& anxiety/depression) was used; a participant was asked to rate each state on a 3-level scale (1=no problem, 2=some problem, \& 3=extreme problem); higher levels indicated greater severity/impairment. The published weights allowed the creation of a single summary score called the EQ-5D index, which ranged from -0.594 to 1; low scores represented a higher level of dysfunction \& 1 as perfect health.
dispersion Type
Standard Error
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 a different drug from that to which they were randomized. Here, 'Number analyzed' signifies the number of participants evaluable at specified time-points.
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- EuroQoL EQ-5D Observed Means - Intent to Treat Population
type
SECONDARY
unit Of Measure
Units on a scale

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Preserved source evidence · Not medical advice