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NCT01520909 · OUTCOME

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2

Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. · Source last updated 2015-03-10

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 Day 1 of Part 2 up to Week 24 of Part 2 + 1 day

What was measured

An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening; requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.

Analysis population: Safety Population

Groups in this outcome

Part 2 (Open-Label Period) - Eltrombopag

Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.

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

Analysis denominator · Participants

GroupSource count
Part 2 (Open-Label Period) - Eltrombopag87

Reported measurements

Any AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag69Not reportedNot reportedNot reportedNot reported
Any SAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        69
    title
    Any AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Any SAE
denoms
  1. counts
    1. group Id
      OG000
      value
      87
    units
    Participants
description
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening; requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.
groups
  1. description
    Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
    id
    OG000
    title
    Part 2 (Open-Label Period) - Eltrombopag
param Type
NUMBER
population Description
Safety Population
reporting Status
POSTED
time Frame
From Day 1 of Part 2 up to Week 24 of Part 2 + 1 day
title
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice