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NCT02038036 · OUTCOME

Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)

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, 40, 52, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247

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: 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
Ruxolitinib68
Best Available Therapy (BAT)70
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-8.4312.341Not reportedNot reportedNot reported
Best Available Therapy (BAT)0.4012.586Not reportedNot reportedNot reported
Week 8

Analysis denominator · Participants

GroupSource count
Ruxolitinib68
Best Available Therapy (BAT)69
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-9.8612.210Not reportedNot reportedNot reported
Best Available Therapy (BAT)1.3712.046Not reportedNot reportedNot reported
Week 16

Analysis denominator · Participants

GroupSource count
Ruxolitinib67
Best Available Therapy (BAT)67
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-9.1413.980Not reportedNot reportedNot reported
Best Available Therapy (BAT)1.4110.760Not reportedNot reportedNot reported
Week 28

Analysis denominator · Participants

GroupSource count
Ruxolitinib65
Best Available Therapy (BAT)23
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-10.2914.204Not reportedNot reportedNot reported
Best Available Therapy (BAT)2.3413.047Not reportedNot reportedNot reported
Week 40

Analysis denominator · Participants

GroupSource count
Ruxolitinib67
Best Available Therapy (BAT)18
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-9.3514.027Not reportedNot reportedNot reported
Best Available Therapy (BAT)0.109.586Not reportedNot reportedNot reported
Week 52

Analysis denominator · Participants

GroupSource count
Ruxolitinib70
Best Available Therapy (BAT)13
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-8.6313.403Not reportedNot reportedNot reported
Best Available Therapy (BAT)0.639.334Not reportedNot reportedNot reported
Week 80

Analysis denominator · Participants

GroupSource count
Ruxolitinib67
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-9.0413.520Not reportedNot reportedNot reported
Week 92

Analysis denominator · Participants

GroupSource count
Ruxolitinib64
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-7.6911.971Not reportedNot reportedNot reported
Week 104

Analysis denominator · Participants

GroupSource count
Ruxolitinib68
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-6.8213.297Not reportedNot reportedNot reported
Week 117

Analysis denominator · Participants

GroupSource count
Ruxolitinib64
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-6.7613.702Not reportedNot reportedNot reported
Week 130

Analysis denominator · Participants

GroupSource count
Ruxolitinib64
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-8.2616.234Not reportedNot reportedNot reported
Week 143

Analysis denominator · Participants

GroupSource count
Ruxolitinib64
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-8.5615.653Not reportedNot reportedNot reported
Week 156

Analysis denominator · Participants

GroupSource count
Ruxolitinib65
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-8.4815.081Not reportedNot reportedNot reported
Week 169

Analysis denominator · Participants

GroupSource count
Ruxolitinib64
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-7.6514.392Not reportedNot reportedNot reported
Week 182

Analysis denominator · Participants

GroupSource count
Ruxolitinib63
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-9.3414.675Not reportedNot reportedNot reported
Week 195

Analysis denominator · Participants

GroupSource count
Ruxolitinib61
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-7.5714.922Not reportedNot reportedNot reported
Week 208

Analysis denominator · Participants

GroupSource count
Ruxolitinib55
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-9.2616.347Not reportedNot reportedNot reported
Week 221

Analysis denominator · Participants

GroupSource count
Ruxolitinib55
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-7.2016.054Not reportedNot reportedNot reported
Week 234

Analysis denominator · Participants

GroupSource count
Ruxolitinib57
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-7.5015.922Not reportedNot reportedNot reported
Week 247

Analysis denominator · Participants

GroupSource count
Ruxolitinib51
Best Available Therapy (BAT)0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-7.8216.905Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.341
        value
        -8.43
      2. group Id
        OG001
        spread
        12.586
        value
        0.40
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      2. group Id
        OG001
        value
        70
      units
      Participants
    title
    Week 4
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.210
        value
        -9.86
      2. group Id
        OG001
        spread
        12.046
        value
        1.37
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      2. group Id
        OG001
        value
        69
      units
      Participants
    title
    Week 8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.980
        value
        -9.14
      2. group Id
        OG001
        spread
        10.760
        value
        1.41
    denoms
    1. counts
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        67
      units
      Participants
    title
    Week 16
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.204
        value
        -10.29
      2. group Id
        OG001
        spread
        13.047
        value
        2.34
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        23
      units
      Participants
    title
    Week 28
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.027
        value
        -9.35
      2. group Id
        OG001
        spread
        9.586
        value
        0.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Week 40
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.403
        value
        -8.63
      2. group Id
        OG001
        spread
        9.334
        value
        0.63
    denoms
    1. counts
      1. group Id
        OG000
        value
        70
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    Week 52
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.520
        value
        -9.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Week 80
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.971
        value
        -7.69
    denoms
    1. counts
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Week 92
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.297
        value
        -6.82
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Week 104
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.702
        value
        -6.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Week 117
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.234
        value
        -8.26
    denoms
    1. counts
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Week 130
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.653
        value
        -8.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Week 143
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      75
    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
    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, 40, 52, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247
title
Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)
type
SECONDARY
unit Of Measure
Score on a scale

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Preserved source evidence · Not medical advice