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NCT02038036 · OUTCOME

Change From Baseline in EQ-5D-5L VAS, by Visit in Patients From BAT Group Who Cross Over to Ruxolitinib After Crossover

Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy. · Source last updated 2021-07-20

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

Measure
MEAN
Unit
Score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28, 52, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247 after cross-over

What was measured

EQ-5D-5L is a standardized instrument for measuring health outcomes in a wide range of health conditions and treatments. It consists of visual analogue scale (EQ VAS) which records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 'Best imaginable health state' and 'worst imaginable health state'. The EQ VAS scores were anchored on 100 = the best health you can imagine and 0 = worst health you can imagine.

Analysis population: Cross-over set consisted of all participants randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib.

Groups in this outcome

Best Available Therapy (BAT)

Participants randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib

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

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)58

Reported measurements

Week +4

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)52
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)4.5414.756Not reportedNot reportedNot reported
Week +8

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)52
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)4.6215.807Not reportedNot reportedNot reported
Week +16

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)52
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)6.5814.667Not reportedNot reportedNot reported
Week +24

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)50
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)6.3817.564Not reportedNot reportedNot reported
Week +28

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)50
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)5.2615.923Not reportedNot reportedNot reported
Week +52

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)41
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)4.7121.006Not reportedNot reportedNot reported
Week 92

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)45
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)8.0916.119Not reportedNot reportedNot reported
Week 104

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)50
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)6.4818.085Not reportedNot reportedNot reported
Week 117

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)49
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)4.9216.983Not reportedNot reportedNot reported
Week 130

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)46
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)4.8720.047Not reportedNot reportedNot reported
Week 143

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)47
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)3.1917.798Not reportedNot reportedNot reported
Week 156

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)46
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)2.6520.221Not reportedNot reportedNot reported
Week 169

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)41
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)4.5913.731Not reportedNot reportedNot reported
Week 182

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)42
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)2.7119.673Not reportedNot reportedNot reported
Week 195

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)40
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)5.6518.286Not reportedNot reportedNot reported
Week 208

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)40
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)5.3518.099Not reportedNot reportedNot reported
Week 221

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)38
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)7.7116.701Not reportedNot reportedNot reported
Week 234

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)37
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)5.3018.342Not reportedNot reportedNot reported
Week 247

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)36
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)4.1416.427Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.756
        value
        4.54
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Week +4
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.807
        value
        4.62
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Week +8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.667
        value
        6.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Week +16
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.564
        value
        6.38
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    Week +24
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.923
        value
        5.26
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    Week +28
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.006
        value
        4.71
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      units
      Participants
    title
    Week +52
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.119
        value
        8.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    Week 92
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.085
        value
        6.48
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    Week 104
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.983
        value
        4.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      units
      Participants
    title
    Week 117
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.047
        value
        4.87
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      units
      Participants
    title
    Week 130
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.798
        value
        3.19
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      units
      Participants
    title
    Week 143
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.221
        value
        2.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      units
      Participants
    title
    Week 156
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    units
    Participants
description
EQ-5D-5L is a standardized instrument for measuring health outcomes in a wide range of health conditions and treatments. It consists of visual analogue scale (EQ VAS) which records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 'Best imaginable health state' and 'worst imaginable health state'. The EQ VAS scores were anchored on 100 = the best health you can imagine and 0 = worst health you can imagine.
dispersion Type
Standard Deviation
groups
  1. description
    Participants randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib
    id
    OG000
    title
    Best Available Therapy (BAT)
param Type
MEAN
population Description
Cross-over set consisted of all participants randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib.
reporting Status
POSTED
time Frame
Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28, 52, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247 after cross-over
title
Change From Baseline in EQ-5D-5L VAS, by Visit in Patients From BAT Group Who Cross Over to Ruxolitinib After Crossover
type
SECONDARY
unit Of Measure
Score on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice