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NCT00375674 · OUTCOME

PROs- EuroQol European Quality of Life Questionnaire Variable Analogue Scale (EQ-VAS) Observed Means

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. The first part assessed the current health state. In this outcome measure, the second part was applied to assess the general health status by using visual analog scale (EQ-5D VAS) which measured participant's self-rated health status on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

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
Sunitinib77.310.999Not reportedNot reportedNot reported
Placebo75.671.080Not reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
Sunitinib261
Placebo268
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib74.391.188Not reportedNot reportedNot reported
Placebo76.991.080Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
Sunitinib234
Placebo261
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib74.201.093Not reportedNot reportedNot reported
Placebo76.851.122Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
Sunitinib231
Placebo246
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib74.141.118Not reportedNot reportedNot reported
Placebo77.341.115Not reportedNot reportedNot reported
Cycle 5

Analysis denominator · Participants

GroupSource count
Sunitinib218
Placebo233
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib73.301.220Not reportedNot reportedNot reported
Placebo77.561.212Not reportedNot reportedNot reported
Cycle 6

Analysis denominator · Participants

GroupSource count
Sunitinib211
Placebo232
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib73.511.250Not reportedNot reportedNot reported
Placebo78.611.130Not reportedNot reportedNot reported
Cycle 7

Analysis denominator · Participants

GroupSource count
Sunitinib199
Placebo218
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib72.271.267Not reportedNot reportedNot reported
Placebo77.491.180Not reportedNot reportedNot reported
Cycle 8

Analysis denominator · Participants

GroupSource count
Sunitinib186
Placebo209
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib73.961.226Not reportedNot reportedNot reported
Placebo77.651.213Not reportedNot reportedNot reported
Cycle 9

Analysis denominator · Participants

GroupSource count
Sunitinib174
Placebo203
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib72.931.424Not reportedNot reportedNot reported
Placebo79.021.168Not reportedNot reportedNot reported
EOT

Analysis denominator · Participants

GroupSource count
Sunitinib251
Placebo246
Values in Units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Sunitinib71.791.139Not reportedNot reportedNot reported
Placebo76.931.283Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.999
        value
        77.31
      2. group Id
        OG001
        spread
        1.080
        value
        75.67
    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
        1.188
        value
        74.39
      2. group Id
        OG001
        spread
        1.080
        value
        76.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        261
      2. group Id
        OG001
        value
        268
      units
      Participants
    title
    Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.093
        value
        74.20
      2. group Id
        OG001
        spread
        1.122
        value
        76.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        234
      2. group Id
        OG001
        value
        261
      units
      Participants
    title
    Cycle 3
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.118
        value
        74.14
      2. group Id
        OG001
        spread
        1.115
        value
        77.34
    denoms
    1. counts
      1. group Id
        OG000
        value
        231
      2. group Id
        OG001
        value
        246
      units
      Participants
    title
    Cycle 4
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.220
        value
        73.30
      2. group Id
        OG001
        spread
        1.212
        value
        77.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        218
      2. group Id
        OG001
        value
        233
      units
      Participants
    title
    Cycle 5
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.250
        value
        73.51
      2. group Id
        OG001
        spread
        1.130
        value
        78.61
    denoms
    1. counts
      1. group Id
        OG000
        value
        211
      2. group Id
        OG001
        value
        232
      units
      Participants
    title
    Cycle 6
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.267
        value
        72.27
      2. group Id
        OG001
        spread
        1.180
        value
        77.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        199
      2. group Id
        OG001
        value
        218
      units
      Participants
    title
    Cycle 7
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.226
        value
        73.96
      2. group Id
        OG001
        spread
        1.213
        value
        77.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        186
      2. group Id
        OG001
        value
        209
      units
      Participants
    title
    Cycle 8
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.424
        value
        72.93
      2. group Id
        OG001
        spread
        1.168
        value
        79.02
    denoms
    1. counts
      1. group Id
        OG000
        value
        174
      2. group Id
        OG001
        value
        203
      units
      Participants
    title
    Cycle 9
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.139
        value
        71.79
      2. group Id
        OG001
        spread
        1.283
        value
        76.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        251
      2. group Id
        OG001
        value
        246
      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. The first part assessed the current health state. In this outcome measure, the second part was applied to assess the general health status by using visual analog scale (EQ-5D VAS) which measured participant's self-rated health status on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
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 European Quality of Life Questionnaire Variable Analogue Scale (EQ-VAS) Observed Means
type
SECONDARY
unit Of Measure
Units on a scale

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Preserved source evidence · Not medical advice