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NCT02279173 · OUTCOME

Number of Participants Reporting Use of Rescue Medications for ITP During the Treatment Period

Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP) · Source last updated 2022-06-23

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose of romiplostim to the end of the treatment period, 36 months

What was measured

Rescue medication is defined as any medication or transfusion, other than romiplostim and excluded medications, that is administered after enrollment to the participant with the intent of raising platelet counts or to prevent bleeding and includes concomitant medications for ITP in which the dose and/or schedule was increased. Permitted rescue medications included the following: * corticosteroids * platelet transfusions * Intravenous immunoglobulin (IVIG) * azathioprine * anti-D immunoglobulin * danazol

Analysis population: Efficacy analysis set

Groups in this outcome

Romiplostim

Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/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
Romiplostim203

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim60Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        60
denoms
  1. counts
    1. group Id
      OG000
      value
      203
    units
    Participants
description
Rescue medication is defined as any medication or transfusion, other than romiplostim and excluded medications, that is administered after enrollment to the participant with the intent of raising platelet counts or to prevent bleeding and includes concomitant medications for ITP in which the dose and/or schedule was increased. Permitted rescue medications included the following: * corticosteroids * platelet transfusions * Intravenous immunoglobulin (IVIG) * azathioprine * anti-D immunoglobulin * danazol
groups
  1. description
    Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
    id
    OG000
    title
    Romiplostim
param Type
COUNT_OF_PARTICIPANTS
population Description
Efficacy analysis set
reporting Status
POSTED
time Frame
From first dose of romiplostim to the end of the treatment period, 36 months
title
Number of Participants Reporting Use of Rescue Medications for ITP During the Treatment Period
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice