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NCT00116688 · OUTCOME

Change From Baseline in ITP Patient Assessment Questionnaire

Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) · Source last updated 2013-12-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
scores on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline to Week 48

What was measured

The ITP Patient Assessment Questionnaire (ITP-PAQ) assesses ITP-specific health-related quality of life (HRQOL). This questionnaire assesses ITP specific health-related quality of life (HRQOL). The questionnaire consists of 44 items and has six domains: These domains assess the impact of ITP on Physical Health, Mental Health, Work, Social Activity, Women's Health and Overall QOL. The impact of ITP on Physical Health consists of four sub-scales, which evaluate ITP related Symptoms, Fatigue, Bother and Activity. The impact of ITP on Mental Health consists of two sub-scales, which evaluate Psychological distress and Fear in a population with ITP. Items are scored from 0-100 with higher scores indicating better HRQOL.

Analysis population: Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.

Groups in this outcome

Romiplostim in Adults

Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Romiplostim in Adults292

Reported measurements

Physical Health Symptoms (N=209)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults4.2013.15Not reportedNot reportedNot reported
Physical Health Fatigue (N=208)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults3.9916.00Not reportedNot reportedNot reported
Physical Health Bother (N=204)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults6.4317.39Not reportedNot reportedNot reported
Physical Health Activity (N=208)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults5.2321.08Not reportedNot reportedNot reported
Emotional Health Psychological (N=208)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults4.0115.81Not reportedNot reportedNot reported
Emotional Health Fear (N=209)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults3.4812.59Not reportedNot reportedNot reported
Overall Quality of Life (N=210)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults8.3219.65Not reportedNot reportedNot reported
Social Quality of Life (N=209)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults3.8913.41Not reportedNot reportedNot reported
Women's Reproductive Health (N=71)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults4.5116.35Not reportedNot reportedNot reported
Work Quality of Life (N=75)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults2.7814.54Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.15
        value
        4.20
    title
    Physical Health Symptoms (N=209)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.00
        value
        3.99
    title
    Physical Health Fatigue (N=208)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.39
        value
        6.43
    title
    Physical Health Bother (N=204)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.08
        value
        5.23
    title
    Physical Health Activity (N=208)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.81
        value
        4.01
    title
    Emotional Health Psychological (N=208)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.59
        value
        3.48
    title
    Emotional Health Fear (N=209)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.65
        value
        8.32
    title
    Overall Quality of Life (N=210)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.41
        value
        3.89
    title
    Social Quality of Life (N=209)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.35
        value
        4.51
    title
    Women's Reproductive Health (N=71)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.54
        value
        2.78
    title
    Work Quality of Life (N=75)
denoms
  1. counts
    1. group Id
      OG000
      value
      292
    units
    Participants
description
The ITP Patient Assessment Questionnaire (ITP-PAQ) assesses ITP-specific health-related quality of life (HRQOL). This questionnaire assesses ITP specific health-related quality of life (HRQOL). The questionnaire consists of 44 items and has six domains: These domains assess the impact of ITP on Physical Health, Mental Health, Work, Social Activity, Women's Health and Overall QOL. The impact of ITP on Physical Health consists of four sub-scales, which evaluate ITP related Symptoms, Fatigue, Bother and Activity. The impact of ITP on Mental Health consists of two sub-scales, which evaluate Psychological distress and Fear in a population with ITP. Items are scored from 0-100 with higher scores indicating better HRQOL.
dispersion Type
Standard Deviation
groups
  1. description
    Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.
    id
    OG000
    title
    Romiplostim in Adults
param Type
MEAN
population Description
Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.
reporting Status
POSTED
time Frame
Baseline to Week 48
title
Change From Baseline in ITP Patient Assessment Questionnaire
type
SECONDARY
unit Of Measure
scores on a scale

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

Preserved source evidence · Not medical advice