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NCT00116688 · OUTCOME

Patient Global Assessment

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
Week 1 and Week 48

What was measured

The Patient Global Assessment is two questions which assess the overall health-related quality of life (HRQOL) and symptoms of the patient. Each item is answered on a 15-point Likert scale ranging from 'A very great deal worse' (1) to 'A very great deal better' (15). A higher score indicates that quality of life or symptoms have improved.

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

Week 1 (N=271)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults7.612.02Not reportedNot reportedNot reported
Week 48 (N=216)
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Romiplostim in Adults8.181.78Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.02
        value
        7.61
    title
    Week 1 (N=271)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.78
        value
        8.18
    title
    Week 48 (N=216)
denoms
  1. counts
    1. group Id
      OG000
      value
      292
    units
    Participants
description
The Patient Global Assessment is two questions which assess the overall health-related quality of life (HRQOL) and symptoms of the patient. Each item is answered on a 15-point Likert scale ranging from 'A very great deal worse' (1) to 'A very great deal better' (15). A higher score indicates that quality of life or symptoms have improved.
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
Week 1 and Week 48
title
Patient Global Assessment
type
SECONDARY
unit Of Measure
scores on a scale

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

Preserved source evidence · Not medical advice