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NCT01520909 · OUTCOME

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1

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 Treatment up to Week 13 of Part 1+ 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: all participants who received at least one dose of the investigational product

Groups in this outcome

Part 1 (Randmoized Period) -Placebo

In Part 1, participants aged between 6 and 17 years with a body weight \<27 kg received placebo 37.5 mg QD, and those with a body weight \>=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.

Part 1 (Randomized Period) - Eltrombopag

In Part 1, participants 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; 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 1 (Randmoized Period) -Placebo29
Part 1 (Randomized Period) - Eltrombopag63

Reported measurements

Any AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 (Randmoized Period) -Placebo21Not reportedNot reportedNot reportedNot reported
Part 1 (Randomized Period) - Eltrombopag51Not reportedNot reportedNot reportedNot reported
Any SAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 (Randmoized Period) -Placebo4Not reportedNot reportedNot reportedNot reported
Part 1 (Randomized Period) - Eltrombopag5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        51
    title
    Any AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
    title
    Any SAE
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      63
    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
    In Part 1, participants aged between 6 and 17 years with a body weight \<27 kg received placebo 37.5 mg QD, and those with a body weight \>=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
    id
    OG000
    title
    Part 1 (Randmoized Period) -Placebo
  2. description
    In Part 1, participants 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; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
    id
    OG001
    title
    Part 1 (Randomized Period) - Eltrombopag
param Type
NUMBER
population Description
Safety Population: all participants who received at least one dose of the investigational product
reporting Status
POSTED
time Frame
From Day 1 of Treatment up to Week 13 of Part 1+ 1 day
title
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice