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NCT02279173 · OUTCOME

Number of Participants With Adverse Events

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
SAEs were collected from Screening through end-of-study follow-up (up to 38 months). Nonserious AEs were collected from first to last dose of study drug during the treatment period (up to 36 months).

What was measured

An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant, which does not necessarily have a causal relationship with study treatment. A serious adverse event (SAE) was defined as an AE that met at least 1 of the following criteria: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event Adverse events were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grading scale, where Grade 1 = mild AE; Grade 2 = moderate AE; Grade 3 = severe AE; Grade 4 = life-threatening or disabling; Grade 5 = death related to AE.

Analysis population: 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

Any adverse event (AE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim193Not reportedNot reportedNot reportedNot reported
Serious adverse events (SAE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim60Not reportedNot reportedNot reportedNot reported
AEs leading to discontinuation of romiplostim
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim15Not reportedNot reportedNot reportedNot reported
Adverse event Grade ≥ 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim66Not reportedNot reportedNot reportedNot reported
Adverse event Grade ≥ 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim19Not reportedNot reportedNot reportedNot reported
Adverse event Grade ≥ 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim0Not reportedNot reportedNot reportedNot reported
Treatment-related adverse events (TRAE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim56Not reportedNot reportedNot reportedNot reported
Treatment-related serious adverse events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim8Not reportedNot reportedNot reportedNot reported
TRAEs leading to discontinuation of romiplostim
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim8Not reportedNot reportedNot reportedNot reported
Treatment-related adverse events Grade ≥ 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim8Not reportedNot reportedNot reportedNot reported
Treatment-related adverse events Grade ≥ 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim0Not reportedNot reportedNot reportedNot reported
Treatment-related adverse events Grade ≥ 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        193
    title
    Any adverse event (AE)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        60
    title
    Serious adverse events (SAE)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    AEs leading to discontinuation of romiplostim
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        66
    title
    Adverse event Grade ≥ 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    Adverse event Grade ≥ 4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Adverse event Grade ≥ 5
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        56
    title
    Treatment-related adverse events (TRAE)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Treatment-related serious adverse events
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    TRAEs leading to discontinuation of romiplostim
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Treatment-related adverse events Grade ≥ 3
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Treatment-related adverse events Grade ≥ 4
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Treatment-related adverse events Grade ≥ 5
denoms
  1. counts
    1. group Id
      OG000
      value
      203
    units
    Participants
description
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant, which does not necessarily have a causal relationship with study treatment. A serious adverse event (SAE) was defined as an AE that met at least 1 of the following criteria: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event Adverse events were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grading scale, where Grade 1 = mild AE; Grade 2 = moderate AE; Grade 3 = severe AE; Grade 4 = life-threatening or disabling; Grade 5 = death related to AE.
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
Participants who received at least 1 dose of romiplostim
reporting Status
POSTED
time Frame
SAEs were collected from Screening through end-of-study follow-up (up to 38 months). Nonserious AEs were collected from first to last dose of study drug during the treatment period (up to 36 months).
title
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice