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NCT01444417 · OUTCOME

Total Number of Composite Bleeding Episodes

Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients · Source last updated 2017-02-09

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

Measure
MEAN
Unit
bleeding episodes
Interval / dispersion
Standard Deviation
Time frame
Week 2 to week 25

What was measured

A composite bleeding episode was defined as clinically significant bleeding events or the use of a rescue medication to prevent a clinical significant bleeding event during weeks 2 through 25 of the treatment period. A clinically significant bleeding event was defined as a Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade ≥ 2 bleeding event.

Analysis population: Efficacy analysis set

Groups in this outcome

Placebo

Participants received weekly subcutaneous placebo for 24 weeks.

Romiplostim

Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L.

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

Analysis denominator · Participants

GroupSource count
Placebo20
Romiplostim42

Reported measurements

Source class 1
Values in bleeding episodes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo4.06.9Not reportedNot reportedNot reported
Romiplostim1.94.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.9
        value
        4.0
      2. group Id
        OG001
        spread
        4.2
        value
        1.9
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      42
    units
    Participants
description
A composite bleeding episode was defined as clinically significant bleeding events or the use of a rescue medication to prevent a clinical significant bleeding event during weeks 2 through 25 of the treatment period. A clinically significant bleeding event was defined as a Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade ≥ 2 bleeding event.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received weekly subcutaneous placebo for 24 weeks.
    id
    OG000
    title
    Placebo
  2. description
    Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L.
    id
    OG001
    title
    Romiplostim
param Type
MEAN
population Description
Efficacy analysis set
reporting Status
POSTED
time Frame
Week 2 to week 25
title
Total Number of Composite Bleeding Episodes
type
SECONDARY
unit Of Measure
bleeding episodes

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

Preserved source evidence · Not medical advice