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NCT02279173 · OUTCOME

Percentage of Time With a Platelet Response During the First 6 Months of Treatment

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
Week 2 to Month 6, platelet response was assessed every week.

What was measured

Platelet response was defined as a platelet count of ≥ 50 x 10⁹/L with no rescue medication use for ITP 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 during the first 6 months was calculated as the number of months a platelet response was observed divided by the total number of months response was assessed.

Analysis population: The efficacy analysis set included all enrolled participants who received at least 1 dose of romiplostim

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
Romiplostim50.00Not reported16.6783.33Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.67
        upper Limit
        83.33
        value
        50.00
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 for ITP 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 during the first 6 months 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
The efficacy analysis set included all enrolled participants who received at least 1 dose of romiplostim
reporting Status
POSTED
time Frame
Week 2 to Month 6, platelet response was assessed every week.
title
Percentage of Time With a Platelet Response During the First 6 Months of Treatment
type
PRIMARY
unit Of Measure
percentage of time

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

Preserved source evidence · Not medical advice