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NCT00515203 · OUTCOME

Requirement for Rescue Therapy (as Defined Per Protocol)

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-week treatment period

What was measured

Participant required rescue therapy (as defined per protocol) during the 12 week treatment period.

Analysis population: Efficacy Analysis Set, composed of all randomized participants

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
Romiplostim2Not reportedNot reportedNot reportedNot reported
Placebo2Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2098
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2098
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      5
    units
    Participants
description
Participant required rescue therapy (as defined per protocol) 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
Efficacy Analysis Set, composed of all randomized participants
reporting Status
POSTED
time Frame
12-week treatment period
title
Requirement for Rescue Therapy (as Defined Per Protocol)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice