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NCT02038036 · OUTCOME

Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI), 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
Percent
Interval / dispersion
Standard Deviation
Time frame
Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28 and 52 after cross-over

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: 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

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

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)13
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-7.4528.102Not reportedNot reportedNot reported
Percent work time missed due to problem (past 7 days) Week +8

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)13
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-3.9033.237Not reportedNot reportedNot reported
Percent work time missed due to problem (past 7 days) Week +16

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)10
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-2.6640.422Not reportedNot reportedNot reported
Percent work time missed due to problem (past 7 days) Week +24

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)9
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-1.675.000Not reportedNot reportedNot reported
Percent work time missed due to problem (past 7 days) Week +28

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)10
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)7.0621.757Not reportedNot reportedNot reported
Percent work time missed due to problem (past 7 days) Week +52

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)8
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)1.123.175Not reportedNot reportedNot reported
Percent impairment while working due to problem (past 7 days) Week +4

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)15
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-5.339.904Not reportedNot reportedNot reported
Percent impairment while working due to problem (past 7 days) Week +8

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)14
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-4.2911.579Not reportedNot reportedNot reported
Percent impairment while working due to problem (past 7 days) Week +16

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)12
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-10.8320.207Not reportedNot reportedNot reported
Percent impairment while working due to problem (past 7 days) Week +24

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)13
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-6.9213.156Not reportedNot reportedNot reported
Percent impairment while working due to problem (past 7 days) Week +28

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)12
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-3.3323.868Not reportedNot reportedNot reported
Percent impairment while working due to problem (past 7 days) Week +52

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)10
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-6.0013.499Not reportedNot reportedNot reported
Percent overall work impairment due to problem (past 7 days) Week +4

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)13
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-10.9820.249Not reportedNot reportedNot reported
Percent overall work impairment due to problem (past 7 days) Week +8

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)13
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-6.9124.416Not reportedNot reportedNot reported
Percent overall work impairment due to problem (past 7 days) Week +16

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)10
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-4.7330.167Not reportedNot reportedNot reported
Percent overall work impairment due to problem (past 7 days) Week +24

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)9
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-6.0614.099Not reportedNot reportedNot reported
Percent overall work impairment due to problem (past 7 days) Week +28

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)10
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-1.8120.220Not reportedNot reportedNot reported
Percent overall work impairment due to problem (past 7 days) Week +52

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)8
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-4.0312.712Not reportedNot reportedNot reported
Percent activity impairment due to problem (past 7 days) Week +4

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)47
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-10.4319.886Not reportedNot reportedNot reported
Percent activity impairment due to problem (past 7 days) Week +8

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)51
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-8.6320.978Not reportedNot reportedNot reported
Percent activity impairment due to problem (past 7 days) Week +16

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)51
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-8.8221.877Not reportedNot reportedNot reported
Percent activity impairment due to problem (past 7 days) Week +24

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)51
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-6.4725.363Not reportedNot reportedNot reported
Percent activity impairment due to problem (past 7 days) Week +28

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)49
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-6.9426.395Not reportedNot reportedNot reported
Percent activity impairment due to problem (past 7 days) Week +52

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)40
Values in Percent · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)-7.0022.781Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.102
        value
        -7.45
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Percent work time missed due to problem (past 7 days) Week +4
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.237
        value
        -3.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Percent work time missed due to problem (past 7 days) Week +8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        40.422
        value
        -2.66
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Percent work time missed due to problem (past 7 days) Week +16
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.000
        value
        -1.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Percent work time missed due to problem (past 7 days) Week +24
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.757
        value
        7.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Percent work time missed due to problem (past 7 days) Week +28
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.175
        value
        1.12
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Percent work time missed due to problem (past 7 days) Week +52
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.904
        value
        -5.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    Percent impairment while working due to problem (past 7 days) Week +4
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.579
        value
        -4.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Percent impairment while working due to problem (past 7 days) Week +8
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.207
        value
        -10.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Percent impairment while working due to problem (past 7 days) Week +16
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.156
        value
        -6.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Percent impairment while working due to problem (past 7 days) Week +24
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.868
        value
        -3.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Percent impairment while working due to problem (past 7 days) Week +28
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.499
        value
        -6.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Percent impairment while working due to problem (past 7 days) Week +52
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    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
    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 and 52 after cross-over
title
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI), by Visit in Patients From BAT Group Who Cross Over to Ruxolitinib After Crossover
type
SECONDARY
unit Of Measure
Percent

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

Preserved source evidence · Not medical advice