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NCT00515203 · OUTCOME

Adverse Events

Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects · Source last updated 2014-07-25

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
12 weeks

What was measured

Occurrence of one or more adverse events in the participant during the 12-week treatment period

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

Groups in this outcome

Romiplostim

Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg

Placebo

Placebo by subcutaneous injection once weekly

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

Analysis denominator · Participants

GroupSource count
Romiplostim17
Placebo5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim16Not reportedNot reportedNot reportedNot reported
Placebo5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      5
    units
    Participants
description
Occurrence of one or more adverse events in the participant during the 12-week treatment period
groups
  1. description
    Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
    id
    OG000
    title
    Romiplostim
  2. description
    Placebo by subcutaneous injection once weekly
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
Safety Analysis Set, composed of all participants who received at least one dose of study medication
reporting Status
POSTED
time Frame
12 weeks
title
Adverse Events
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice