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NCT01143038 · OUTCOME

Number of Participants With Adverse Events

Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim · Source last updated 2022-09-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From first dose date of romiplostim to end of study (up to 24 months).

What was measured

An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other significant medical hazard. Whether an adverse event was treatment-related (TRAE) or not was determined by investigator.

Analysis population: Safety analysis set

Groups in this outcome

Romiplostim

Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10\^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10\^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10\^9/L could reinitiate romiplostim for up to 8 weeks.

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

Analysis denominator · Participants

GroupSource count
Romiplostim75

Reported measurements

All adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim63Not reportedNot reportedNot reportedNot reported
Serious adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim17Not reportedNot reportedNot reportedNot reported
Leading to discontinuation of romiplostim
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim4Not reportedNot reportedNot reportedNot reported
Leading to discontinuation from study
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim3Not reportedNot reportedNot reportedNot reported
Fatal adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim0Not reportedNot reportedNot reportedNot reported
Treatment-related adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim21Not reportedNot reportedNot reportedNot reported
Treatment-related serious adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim3Not reportedNot reportedNot reportedNot reported
TRAE leading to discontinuation of romiplostim
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim2Not reportedNot reportedNot reportedNot reported
TRAE leading to discontinuation from study
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romiplostim2Not reportedNot reportedNot reportedNot reported
Treatment-related fatal adverse events
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
        63
    title
    All adverse events
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Serious adverse events
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Leading to discontinuation of romiplostim
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Leading to discontinuation from study
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Fatal adverse events
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    title
    Treatment-related adverse event
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Treatment-related serious adverse events
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    TRAE leading to discontinuation of romiplostim
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    TRAE leading to discontinuation from study
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Treatment-related fatal adverse events
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    units
    Participants
description
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other significant medical hazard. Whether an adverse event was treatment-related (TRAE) or not was determined by investigator.
groups
  1. description
    Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10\^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10\^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10\^9/L could reinitiate romiplostim for up to 8 weeks.
    id
    OG000
    title
    Romiplostim
param Type
NUMBER
population Description
Safety analysis set
reporting Status
POSTED
time Frame
From first dose date of romiplostim to end of study (up to 24 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