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NCT00116688 · OUTCOME

Number of Participants With Adverse Events

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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Duration of treatment plus 8 weeks (up to 285 weeks)

What was measured

Participants with one or more occurrences of one or more adverse events up to 8 weeks after the end of treatment. Participants with more than one event were only counted once.

Analysis population: Safety Analysis Set, composed of all participants who received at least one dose of romiplostim

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.

Romiplostim in Pediatric Population

Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.

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 Adults291
Romiplostim in Pediatric Population20

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim in Adults284Not reportedNot reportedNot reportedNot reported
Romiplostim in Pediatric Population19Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        284
      2. group Id
        OG001
        value
        19
denoms
  1. counts
    1. group Id
      OG000
      value
      291
    2. group Id
      OG001
      value
      20
    units
    Participants
description
Participants with one or more occurrences of one or more adverse events up to 8 weeks after the end of treatment. Participants with more than one event were only counted once.
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
  2. description
    Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
    id
    OG001
    title
    Romiplostim in Pediatric Population
param Type
NUMBER
population Description
Safety Analysis Set, composed of all participants who received at least one dose of romiplostim
reporting Status
POSTED
time Frame
Duration of treatment plus 8 weeks (up to 285 weeks)
title
Number of Participants With Adverse Events
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice