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NCT02038036 · OUTCOME

Change From Baseline in Total Scores of MPN-SAF 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, 40, 52, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247 after cross-over

What was measured

The MPN-SAF TSS is a disease specific questionnaire comprised of 10 items that measures fatigue related to MPN disease and the severity of nine of the most prevalent associated symptoms. Each item is scored on a scale ranging from 0 (no fatigue/absent) to 10 (As bad as you can imagine/worst imaginable).The MPN-SAF TSS is computed as the average of the observed items multiplied by 10 to achieve a 0-to-100 scale. The MPN-SAF TSS thus has a possible score range of 0 to 100 where a decrease indicates improvement.

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)-8.0010.532Not reportedNot reportedNot reported
Week +8

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)53
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-9.7611.543Not 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)-9.4012.040Not reportedNot reportedNot reported
Week +24

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)51
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-9.1512.738Not 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)-8.4612.212Not reportedNot reportedNot reported
Week +40

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)-8.5813.302Not reportedNot reportedNot reported
Week +52

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)-7.1514.392Not 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)-10.4913.902Not reportedNot reportedNot reported
Week 104

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)51
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-8.0816.288Not 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)-9.0114.708Not 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)-10.1815.740Not 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)-8.3617.030Not reportedNot reportedNot reported
Week 156

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)-9.5414.573Not reportedNot reportedNot reported
Week 169

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)-11.1514.305Not reportedNot reportedNot reported
Week 182

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)43
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-10.1316.113Not reportedNot reportedNot reported
Week 195

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)-10.8814.357Not 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)-9.4315.360Not 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)-10.0215.986Not reportedNot reportedNot reported
Week 234

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)-8.0114.404Not reportedNot reportedNot reported
Week 247

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)-9.8414.979Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.532
        value
        -8.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Week +4
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.543
        value
        -9.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      units
      Participants
    title
    Week +8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.040
        value
        -9.40
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Week +16
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.738
        value
        -9.15
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      units
      Participants
    title
    Week +24
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.212
        value
        -8.46
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    Week +28
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.302
        value
        -8.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      units
      Participants
    title
    Week +40
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.392
        value
        -7.15
    denoms
    1. counts
      1. group Id
        OG000
        value
        42
      units
      Participants
    title
    Week +52
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.902
        value
        -10.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    Week 92
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.288
        value
        -8.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      units
      Participants
    title
    Week 104
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.708
        value
        -9.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      units
      Participants
    title
    Week 117
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.740
        value
        -10.18
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      units
      Participants
    title
    Week 130
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.030
        value
        -8.36
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      units
      Participants
    title
    Week 143
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    units
    Participants
description
The MPN-SAF TSS is a disease specific questionnaire comprised of 10 items that measures fatigue related to MPN disease and the severity of nine of the most prevalent associated symptoms. Each item is scored on a scale ranging from 0 (no fatigue/absent) to 10 (As bad as you can imagine/worst imaginable).The MPN-SAF TSS is computed as the average of the observed items multiplied by 10 to achieve a 0-to-100 scale. The MPN-SAF TSS thus has a possible score range of 0 to 100 where a decrease indicates improvement.
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, 40, 52, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247 after cross-over
title
Change From Baseline in Total Scores of MPN-SAF 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