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NCT00908037 · OUTCOME

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

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 7 of Part 2

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 were analyzed.

Groups in this outcome

Part 2 (Randomized Period) Cohort 1-Placebo

Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.

Part 2 (Randomized Period) Cohort 1- Eltrombopag

Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose eltrombopag was 37.5 mg QD. The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.

Part 2 (Randomized Period) Cohort 2-Placebo

Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.

Part 2 (Randomized Period) Cohort 2-Eltrombopag

Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.

Part 2 (Randomized Period) Cohort 3-Placebo

Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.

Part 2 (Randomized Period) Cohort 3- Eltrombopag

Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, as approved by the investigator, and could not exceed 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 (Randomized Period) Cohort 1-Placebo8
Part 2 (Randomized Period) Cohort 1- Eltrombopag16
Part 2 (Randomized Period) Cohort 2-Placebo9
Part 2 (Randomized Period) Cohort 2-Eltrombopag17
Part 2 (Randomized Period) Cohort 3-Placebo4
Part 2 (Randomized Period) Cohort 3- Eltrombopag11

Reported measurements

Any AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Randomized Period) Cohort 1-Placebo8Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag13Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 2-Placebo9Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag14Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 3-Placebo3Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag9Not reportedNot reportedNot reportedNot reported
Any SAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Randomized Period) Cohort 1-Placebo1Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag1Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 2-Placebo1Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag3Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 3-Placebo0Not reportedNot reportedNot reportedNot reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        14
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        9
    title
    Any AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Any SAE
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      17
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      11
    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 aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
    id
    OG000
    title
    Part 2 (Randomized Period) Cohort 1-Placebo
  2. description
    Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose eltrombopag was 37.5 mg QD. The participants of East Asian ancestry began at 12.5 mg QD. 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 (Randomized Period) Cohort 1- Eltrombopag
  3. description
    Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
    id
    OG002
    title
    Part 2 (Randomized Period) Cohort 2-Placebo
  4. description
    Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
    id
    OG003
    title
    Part 2 (Randomized Period) Cohort 2-Eltrombopag
  5. description
    Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
    id
    OG004
    title
    Part 2 (Randomized Period) Cohort 3-Placebo
  6. description
    Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, as approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
    id
    OG005
    title
    Part 2 (Randomized Period) Cohort 3- Eltrombopag
param Type
NUMBER
population Description
Safety Population: all participants who received at least one dose of the investigational product during Part 2 were analyzed.
reporting Status
POSTED
time Frame
From Treatment + 1 day up to Week 7 of Part 2
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