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NCT02038036 · OUTCOME

Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-level (EQ-5D-5L) Questionnaire

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, Week 4, 8, 16, 28, 52, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247

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: Full Analysis Set (FAS) included all participants to whom study treatment was assigned by randomization and had valid measurements for the outcome measure. Data after crossover for participants randomized to BAT are reported as separate outcome measure.

Groups in this outcome

Ruxolitinib

Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid

Best Available Therapy (BAT)

Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with 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
Ruxolitinib74
Best Available Therapy (BAT)75

Reported measurements

Week 4

Analysis denominator · Participants

GroupSource count
Ruxolitinib67
Best Available Therapy (BAT)69
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib4.2411.661Not reportedNot reportedNot reported
Best Available Therapy (BAT)0.0418.323Not reportedNot reportedNot reported
Week 8

Analysis denominator · Participants

GroupSource count
Ruxolitinib66
Best Available Therapy (BAT)67
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib7.6214.846Not reportedNot reportedNot reported
Best Available Therapy (BAT)-2.7316.097Not reportedNot reportedNot reported
Week 16

Analysis denominator · Participants

GroupSource count
Ruxolitinib63
Best Available Therapy (BAT)65
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib6.3517.946Not reportedNot reportedNot reported
Best Available Therapy (BAT)-3.1214.435Not reportedNot reportedNot reported
Week 28

Analysis denominator · Participants

GroupSource count
Ruxolitinib63
Best Available Therapy (BAT)25
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib7.5614.309Not reportedNot reportedNot reported
Best Available Therapy (BAT)0.1615.201Not reportedNot reportedNot reported
Week 52

Analysis denominator · Participants

GroupSource count
Ruxolitinib66
Best Available Therapy (BAT)14
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib7.3613.996Not reportedNot reportedNot reported
Best Available Therapy (BAT)2.5010.697Not reportedNot reportedNot reported
Week 80

Analysis denominator · Participants

GroupSource count
Ruxolitinib64
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib4.5018.273Not reportedNot reportedNot reported
Week 92

Analysis denominator · Participants

GroupSource count
Ruxolitinib62
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib6.7718.948Not reportedNot reportedNot reported
Week 104

Analysis denominator · Participants

GroupSource count
Ruxolitinib64
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib6.2518.143Not reportedNot reportedNot reported
Week 117

Analysis denominator · Participants

GroupSource count
Ruxolitinib62
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib6.4215.130Not reportedNot reportedNot reported
Week 130

Analysis denominator · Participants

GroupSource count
Ruxolitinib61
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib7.7016.488Not reportedNot reportedNot reported
Week 143

Analysis denominator · Participants

GroupSource count
Ruxolitinib59
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib5.6817.332Not reportedNot reportedNot reported
Week 156

Analysis denominator · Participants

GroupSource count
Ruxolitinib62
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib4.7419.032Not reportedNot reportedNot reported
Week 169

Analysis denominator · Participants

GroupSource count
Ruxolitinib61
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib6.0818.717Not reportedNot reportedNot reported
Week 182

Analysis denominator · Participants

GroupSource count
Ruxolitinib60
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib7.6817.992Not reportedNot reportedNot reported
Week 195

Analysis denominator · Participants

GroupSource count
Ruxolitinib59
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib6.4118.239Not reportedNot reportedNot reported
Week 208

Analysis denominator · Participants

GroupSource count
Ruxolitinib53
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib7.9418.614Not reportedNot reportedNot reported
Week 221

Analysis denominator · Participants

GroupSource count
Ruxolitinib53
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib3.6419.866Not reportedNot reportedNot reported
Week 234

Analysis denominator · Participants

GroupSource count
Ruxolitinib54
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib5.4818.625Not reportedNot reportedNot reported
Week 247

Analysis denominator · Participants

GroupSource count
Ruxolitinib50
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib6.2817.854Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.661
        value
        4.24
      2. group Id
        OG001
        spread
        18.323
        value
        0.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        69
      units
      Participants
    title
    Week 4
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.846
        value
        7.62
      2. group Id
        OG001
        spread
        16.097
        value
        -2.73
    denoms
    1. counts
      1. group Id
        OG000
        value
        66
      2. group Id
        OG001
        value
        67
      units
      Participants
    title
    Week 8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.946
        value
        6.35
      2. group Id
        OG001
        spread
        14.435
        value
        -3.12
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      2. group Id
        OG001
        value
        65
      units
      Participants
    title
    Week 16
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.309
        value
        7.56
      2. group Id
        OG001
        spread
        15.201
        value
        0.16
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      2. group Id
        OG001
        value
        25
      units
      Participants
    title
    Week 28
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.996
        value
        7.36
      2. group Id
        OG001
        spread
        10.697
        value
        2.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        66
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    Week 52
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.273
        value
        4.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Week 80
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.948
        value
        6.77
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Week 92
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.143
        value
        6.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Week 104
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.130
        value
        6.42
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Week 117
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.488
        value
        7.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Week 130
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.332
        value
        5.68
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Week 143
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.032
        value
        4.74
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Week 156
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      75
    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
    Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid
    id
    OG000
    title
    Ruxolitinib
  2. description
    Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib
    id
    OG001
    title
    Best Available Therapy (BAT)
param Type
MEAN
population Description
Full Analysis Set (FAS) included all participants to whom study treatment was assigned by randomization and had valid measurements for the outcome measure. Data after crossover for participants randomized to BAT are reported as separate outcome measure.
reporting Status
POSTED
time Frame
Baseline, Week 4, 8, 16, 28, 52, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247
title
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-level (EQ-5D-5L) Questionnaire
type
SECONDARY
unit Of Measure
Score on a scale

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

Preserved source evidence · Not medical advice