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NCT00908037 · OUTCOME

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3

Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP) · Source last updated 2018-10-12

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 Treatment + 1 day up to Week 31 of Part2/3

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 during Part 2/3 were analyzed

Groups in this outcome

Part 2/3 (Eltrombopag Open-Label Period) Cohort 1

All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.

Part 2/3 (Eltrombopag Open-Label Period) Cohort 2

All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of \<=27 kg received 25 mg QD and participants with a body weight of \>=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.

Part 2/3 (Eltrombopag Open- Label Period) Cohort 3

All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.

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 2/3 (Eltrombopag Open-Label Period) Cohort 124
Part 2/3 (Eltrombopag Open-Label Period) Cohort 226
Part 2/3 (Eltrombopag Open- Label Period) Cohort 315

Reported measurements

Any AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2/3 (Eltrombopag Open-Label Period) Cohort 122Not reportedNot reportedNot reportedNot reported
Part 2/3 (Eltrombopag Open-Label Period) Cohort 226Not reportedNot reportedNot reportedNot reported
Part 2/3 (Eltrombopag Open- Label Period) Cohort 314Not reportedNot reportedNot reportedNot reported
Any SAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2/3 (Eltrombopag Open-Label Period) Cohort 13Not reportedNot reportedNot reportedNot reported
Part 2/3 (Eltrombopag Open-Label Period) Cohort 25Not reportedNot reportedNot reportedNot reported
Part 2/3 (Eltrombopag Open- Label Period) Cohort 30Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        26
      3. group Id
        OG002
        value
        14
    title
    Any AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        0
    title
    Any SAE
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      26
    3. group Id
      OG002
      value
      15
    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
    All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
    id
    OG000
    title
    Part 2/3 (Eltrombopag Open-Label Period) Cohort 1
  2. description
    All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of \<=27 kg received 25 mg QD and participants with a body weight of \>=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
    id
    OG001
    title
    Part 2/3 (Eltrombopag Open-Label Period) Cohort 2
  3. description
    All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
    id
    OG002
    title
    Part 2/3 (Eltrombopag Open- Label Period) Cohort 3
param Type
NUMBER
population Description
Safety Population: all participants who received at least one dose of the investigational product during Part 2/3 were analyzed
reporting Status
POSTED
time Frame
From Treatment + 1 day up to Week 31 of Part2/3
title
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice