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NCT02279173 · OUTCOME

Percentage of Time With a Platelet Response During the Overall 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
MEDIAN
Unit
percentage of time
Interval / dispersion
Inter-Quartile Range
Time frame
From week 2 to the end of the treatment period, 36 months

What was measured

Platelet response was defined as a platelet count of ≥ 50 x 10⁹/L with no rescue medication use in the past 4 weeks. Monthly platelet response was calculated based on the median platelet count during each month. For each participant, the percentage of time with platelet response was calculated as the number of months a platelet response was observed divided by the total number of months response was assessed.

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 percentage of time · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Romiplostim78.21Not reported26.6790.39Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        26.67
        upper Limit
        90.39
        value
        78.21
denoms
  1. counts
    1. group Id
      OG000
      value
      203
    units
    Participants
description
Platelet response was defined as a platelet count of ≥ 50 x 10⁹/L with no rescue medication use in the past 4 weeks. Monthly platelet response was calculated based on the median platelet count during each month. For each participant, the percentage of time with platelet response was calculated as the number of months a platelet response was observed divided by the total number of months response was assessed.
dispersion Type
Inter-Quartile Range
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
MEDIAN
population Description
Efficacy analysis set
reporting Status
POSTED
time Frame
From week 2 to the end of the treatment period, 36 months
title
Percentage of Time With a Platelet Response During the Overall Treatment Period
type
SECONDARY
unit Of Measure
percentage of time

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

Preserved source evidence · Not medical advice