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NCT00116688 · OUTCOME

Change From Baseline in Short Form 36 (SF-36)

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 SF-36 is a widely used generic health-related quality of life measure. It has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Items are scored from 0 to 100 with higher scores indicating better health status.

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 Functioning (N=206)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults1.386.34Not reportedNot reportedNot reported
Role-Physical (N=208)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults2.038.89Not reportedNot reportedNot reported
Bodily Pain (N=206)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults0.947.99Not reportedNot reportedNot reported
General Health Perception (N=208)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults1.317.03Not reportedNot reportedNot reported
Vitality (N=208)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults1.687.47Not reportedNot reportedNot reported
Social Functioning (N=208)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults0.528.21Not reportedNot reportedNot reported
Role-Emotional (N=205)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults1.7512.22Not reportedNot reportedNot reported
Mental Health Index (N=208)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults0.917.45Not reportedNot reportedNot reported
Physical Component Summary (N=200)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults1.496.51Not reportedNot reportedNot reported
Mental Component Summary (N=200)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults1.068.80Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.34
        value
        1.38
    title
    Physical Functioning (N=206)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.89
        value
        2.03
    title
    Role-Physical (N=208)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.99
        value
        0.94
    title
    Bodily Pain (N=206)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.03
        value
        1.31
    title
    General Health Perception (N=208)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.47
        value
        1.68
    title
    Vitality (N=208)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.21
        value
        0.52
    title
    Social Functioning (N=208)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.22
        value
        1.75
    title
    Role-Emotional (N=205)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.45
        value
        0.91
    title
    Mental Health Index (N=208)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.51
        value
        1.49
    title
    Physical Component Summary (N=200)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.80
        value
        1.06
    title
    Mental Component Summary (N=200)
denoms
  1. counts
    1. group Id
      OG000
      value
      292
    units
    Participants
description
The SF-36 is a widely used generic health-related quality of life measure. It has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Items are scored from 0 to 100 with higher scores indicating better health status.
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 Short Form 36 (SF-36)
type
SECONDARY
unit Of Measure
scores on a scale

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

Preserved source evidence · Not medical advice