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NCT02279173 · OUTCOME

Percentage of Participants Who Developed Bone Marrow Abnormalities

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Year 1 (Cohort 1) and year 2 (Cohort 2)

What was measured

The percentage of participants with bone marrow abnormalities (eg, myelodysplastic syndrome, monosomy 7) based on analysis of bone marrow biopsy and aspirate samples using cytogenetics and fluorescence in situ hybridization.

Analysis population: Bone marrow analysis set participants with an on-study bone marrow abnormality assessment

Groups in this outcome

Cohort 1

Participants enrolled under the protocol supplement in the EU, Switzerland, or Turkey received weekly romiplostim for 3 years and had a bone marrow biopsy at baseline and year 1.

Cohort 2

Participants enrolled under the protocol supplement in the EU, Switzerland, or Turkey received weekly romiplostim for 3 years and had a bone marrow biopsy at baseline and year 2.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 127
Cohort 231

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 10.0Not reported0.012.8Not reported
Cohort 20.0Not reported0.011.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        12.8
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        11.2
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      31
    units
    Participants
description
The percentage of participants with bone marrow abnormalities (eg, myelodysplastic syndrome, monosomy 7) based on analysis of bone marrow biopsy and aspirate samples using cytogenetics and fluorescence in situ hybridization.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants enrolled under the protocol supplement in the EU, Switzerland, or Turkey received weekly romiplostim for 3 years and had a bone marrow biopsy at baseline and year 1.
    id
    OG000
    title
    Cohort 1
  2. description
    Participants enrolled under the protocol supplement in the EU, Switzerland, or Turkey received weekly romiplostim for 3 years and had a bone marrow biopsy at baseline and year 2.
    id
    OG001
    title
    Cohort 2
param Type
NUMBER
population Description
Bone marrow analysis set participants with an on-study bone marrow abnormality assessment
reporting Status
POSTED
time Frame
Year 1 (Cohort 1) and year 2 (Cohort 2)
title
Percentage of Participants Who Developed Bone Marrow Abnormalities
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice