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NCT02038036 · OUTCOME

Change From Baseline in Work Productivity and Activity Impairment (WPAI) 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
Percent
Interval / dispersion
Standard Deviation
Time frame
Baseline, Week 4, 8, 16, 28, 52 and 80

What was measured

The Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) is a six item questionnaire which intended to measure work and activity impairment associated with polycythemia vera. WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the polycythemia vera; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the polycythemia vera on productivity while working; Q6=Impact of the polycythemia vera on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. Scores were multiplied by 100 to express in percentages. Percent work time missed due to problem (past 7 days) =Q2/(Q2+Q4) Percent impairment while working due to problem (past 7 days): Q5/10 Percent overall work impairment due to problem (past 7 says): Q2/(Q2+Q4)+\[(1 Q2/(Q2+Q4))x(Q5/10)\] Percent activity impairment due to problem (past 7 says): Q6/10

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

Percent work time missed due to problem (past 7 days) Week 4

Analysis denominator · Participants

GroupSource count
Ruxolitinib18
Best Available Therapy (BAT)18
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-5.5018.425Not reportedNot reportedNot reported
Best Available Therapy (BAT)-0.4013.928Not reportedNot reportedNot reported
Percent work time missed due to problem (past 7 days) Week 8

Analysis denominator · Participants

GroupSource count
Ruxolitinib15
Best Available Therapy (BAT)16
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-4.8813.381Not reportedNot reportedNot reported
Best Available Therapy (BAT)-4.3520.820Not reportedNot reportedNot reported
Percent work time missed due to problem (past 7 days) Week 16

Analysis denominator · Participants

GroupSource count
Ruxolitinib17
Best Available Therapy (BAT)17
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib4.5035.948Not reportedNot reportedNot reported
Best Available Therapy (BAT)4.7925.917Not reportedNot reportedNot reported
Percent work time missed due to problem (past 7 days) Week 28

Analysis denominator · Participants

GroupSource count
Ruxolitinib17
Best Available Therapy (BAT)4
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-5.8517.119Not reportedNot reportedNot reported
Best Available Therapy (BAT)-2.199.852Not reportedNot reportedNot reported
Percent work time missed due to problem (past 7 days) Week 52

Analysis denominator · Participants

GroupSource count
Ruxolitinib17
Best Available Therapy (BAT)2
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-2.8230.770Not reportedNot reportedNot reported
Best Available Therapy (BAT)-8.3311.785Not reportedNot reportedNot reported
Percent work time missed due to problem (past 7 days) Week 80

Analysis denominator · Participants

GroupSource count
Ruxolitinib15
Best Available Therapy (BAT)0
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib1.8734.151Not reportedNot reportedNot reported
Percent impairment while working due to problem (past 7 days) Week 4

Analysis denominator · Participants

GroupSource count
Ruxolitinib21
Best Available Therapy (BAT)18
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-6.6723.310Not reportedNot reportedNot reported
Best Available Therapy (BAT)0.0014.951Not reportedNot reportedNot reported
Percent impairment while working due to problem (past 7 days) Week 8

Analysis denominator · Participants

GroupSource count
Ruxolitinib19
Best Available Therapy (BAT)17
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-13.1619.164Not reportedNot reportedNot reported
Best Available Therapy (BAT)-0.5913.449Not reportedNot reportedNot reported
Percent impairment while working due to problem (past 7 days) Week 16

Analysis denominator · Participants

GroupSource count
Ruxolitinib20
Best Available Therapy (BAT)17
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-14.0021.374Not reportedNot reportedNot reported
Best Available Therapy (BAT)4.1216.977Not reportedNot reportedNot reported
Percent impairment while working due to problem (past 7 days) Week 28

Analysis denominator · Participants

GroupSource count
Ruxolitinib21
Best Available Therapy (BAT)4
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-14.2923.994Not reportedNot reportedNot reported
Best Available Therapy (BAT)-10.0014.142Not reportedNot reportedNot reported
Percent impairment while working due to problem (past 7 days) Week 52

Analysis denominator · Participants

GroupSource count
Ruxolitinib20
Best Available Therapy (BAT)2
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-10.0023.170Not reportedNot reportedNot reported
Best Available Therapy (BAT)-20.0042.426Not reportedNot reportedNot reported
Percent impairment while working due to problem (past 7 days) Week 80

Analysis denominator · Participants

GroupSource count
Ruxolitinib21
Best Available Therapy (BAT)0
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-14.7626.385Not reportedNot reportedNot reported
Percent overall work impairment due to problem (past 7 days) Week 4

Analysis denominator · Participants

GroupSource count
Ruxolitinib17
Best Available Therapy (BAT)15
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-9.6322.495Not reportedNot reportedNot reported
Best Available Therapy (BAT)-2.3414.807Not reportedNot reportedNot reported
Percent overall work impairment due to problem (past 7 days) Week 8

Analysis denominator · Participants

GroupSource count
Ruxolitinib13
Best Available Therapy (BAT)13
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-11.3218.505Not reportedNot reportedNot reported
Best Available Therapy (BAT)-4.3817.568Not reportedNot reportedNot reported
Percent overall work impairment due to problem (past 7 days) Week 16

Analysis denominator · Participants

GroupSource count
Ruxolitinib15
Best Available Therapy (BAT)14
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-10.2633.296Not reportedNot reportedNot reported
Best Available Therapy (BAT)5.3422.063Not reportedNot reportedNot reported
Percent overall work impairment due to problem (past 7 days) Week 28

Analysis denominator · Participants

GroupSource count
Ruxolitinib16
Best Available Therapy (BAT)4
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-15.9823.077Not reportedNot reportedNot reported
Best Available Therapy (BAT)-8.8511.722Not reportedNot reportedNot reported
Percent overall work impairment due to problem (past 7 days) Week 52

Analysis denominator · Participants

GroupSource count
Ruxolitinib16
Best Available Therapy (BAT)2
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-12.6127.576Not reportedNot reportedNot reported
Best Available Therapy (BAT)-22.5045.962Not reportedNot reportedNot reported
Percent overall work impairment due to problem (past 7 days) Week 80

Analysis denominator · Participants

GroupSource count
Ruxolitinib14
Best Available Therapy (BAT)0
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-14.3630.691Not reportedNot reportedNot reported
Percent activity impairment due to problem (past 7 days) Week 4

Analysis denominator · Participants

GroupSource count
Ruxolitinib61
Best Available Therapy (BAT)66
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-11.9722.122Not reportedNot reportedNot reported
Best Available Therapy (BAT)2.4224.310Not reportedNot reportedNot reported
Percent activity impairment due to problem (past 7 days) Week 8

Analysis denominator · Participants

GroupSource count
Ruxolitinib57
Best Available Therapy (BAT)61
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-11.5824.985Not reportedNot reportedNot reported
Best Available Therapy (BAT)1.9716.413Not reportedNot reportedNot reported
Percent activity impairment due to problem (past 7 days) Week 16

Analysis denominator · Participants

GroupSource count
Ruxolitinib55
Best Available Therapy (BAT)62
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-14.3625.222Not reportedNot reportedNot reported
Best Available Therapy (BAT)0.6518.980Not reportedNot reportedNot reported
Percent activity impairment due to problem (past 7 days) Week 28

Analysis denominator · Participants

GroupSource count
Ruxolitinib54
Best Available Therapy (BAT)22
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-11.6725.826Not reportedNot reportedNot reported
Best Available Therapy (BAT)2.7323.941Not reportedNot reportedNot reported
Percent activity impairment due to problem (past 7 days) Week 52

Analysis denominator · Participants

GroupSource count
Ruxolitinib57
Best Available Therapy (BAT)12
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-11.2325.360Not reportedNot reportedNot reported
Best Available Therapy (BAT)0.0015.374Not reportedNot reportedNot reported
Percent activity impairment due to problem (past 7 days) Week 80

Analysis denominator · Participants

GroupSource count
Ruxolitinib55
Best Available Therapy (BAT)0
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ruxolitinib-11.0924.166Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.425
        value
        -5.50
      2. group Id
        OG001
        spread
        13.928
        value
        -0.40
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Percent work time missed due to problem (past 7 days) Week 4
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.381
        value
        -4.88
      2. group Id
        OG001
        spread
        20.820
        value
        -4.35
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        16
      units
      Participants
    title
    Percent work time missed due to problem (past 7 days) Week 8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.948
        value
        4.50
      2. group Id
        OG001
        spread
        25.917
        value
        4.79
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    Percent work time missed due to problem (past 7 days) Week 16
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.119
        value
        -5.85
      2. group Id
        OG001
        spread
        9.852
        value
        -2.19
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Percent work time missed due to problem (past 7 days) Week 28
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.770
        value
        -2.82
      2. group Id
        OG001
        spread
        11.785
        value
        -8.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Percent work time missed due to problem (past 7 days) Week 52
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        34.151
        value
        1.87
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Percent work time missed due to problem (past 7 days) Week 80
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.310
        value
        -6.67
      2. group Id
        OG001
        spread
        14.951
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Percent impairment while working due to problem (past 7 days) Week 4
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.164
        value
        -13.16
      2. group Id
        OG001
        spread
        13.449
        value
        -0.59
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    Percent impairment while working due to problem (past 7 days) Week 8
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.374
        value
        -14.00
      2. group Id
        OG001
        spread
        16.977
        value
        4.12
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    Percent impairment while working due to problem (past 7 days) Week 16
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.994
        value
        -14.29
      2. group Id
        OG001
        spread
        14.142
        value
        -10.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Percent impairment while working due to problem (past 7 days) Week 28
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.170
        value
        -10.00
      2. group Id
        OG001
        spread
        42.426
        value
        -20.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Percent impairment while working due to problem (past 7 days) Week 52
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.385
        value
        -14.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Percent impairment while working due to problem (past 7 days) Week 80
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      75
    units
    Participants
description
The Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) is a six item questionnaire which intended to measure work and activity impairment associated with polycythemia vera. WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the polycythemia vera; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the polycythemia vera on productivity while working; Q6=Impact of the polycythemia vera on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. Scores were multiplied by 100 to express in percentages. Percent work time missed due to problem (past 7 days) =Q2/(Q2+Q4) Percent impairment while working due to problem (past 7 days): Q5/10 Percent overall work impairment due to problem (past 7 says): Q2/(Q2+Q4)+\[(1 Q2/(Q2+Q4))x(Q5/10)\] Percent activity impairment due to problem (past 7 says): Q6/10
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 and 80
title
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire
type
SECONDARY
unit Of Measure
Percent

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

Preserved source evidence · Not medical advice