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NCT02279173 · OUTCOME

Percentage of Time With an Increase in Platelet Count ≥ 20 x 10⁹ Cells/L Above Baseline

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
Baseline and from week 2 to month 36

What was measured

The percentage of time with an increase in platelet count ≥ 20 x 10⁹ cells/L above baseline from week 2 until the end of the treatment period without rescue medication use within the past 4 weeks. For each participant, the percentage of time with an increase in platelet count ≥ 20 x10⁹ cells/L above baseline was calculated as the number of months the median platelet count was ≥ 20 x10⁹ cells/L above baseline divided by the total number of months 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
Romiplostim80.13Not reported39.1392.31Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.13
        upper Limit
        92.31
        value
        80.13
denoms
  1. counts
    1. group Id
      OG000
      value
      203
    units
    Participants
description
The percentage of time with an increase in platelet count ≥ 20 x 10⁹ cells/L above baseline from week 2 until the end of the treatment period without rescue medication use within the past 4 weeks. For each participant, the percentage of time with an increase in platelet count ≥ 20 x10⁹ cells/L above baseline was calculated as the number of months the median platelet count was ≥ 20 x10⁹ cells/L above baseline divided by the total number of months 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
Baseline and from week 2 to month 36
title
Percentage of Time With an Increase in Platelet Count ≥ 20 x 10⁹ Cells/L Above Baseline
type
SECONDARY
unit Of Measure
percentage of time

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

Preserved source evidence · Not medical advice