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NCT00908037 · OUTCOME

Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in 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
MEDIAN
Unit
Weeks
Interval / dispersion
Full Range
Time frame
From Baseline through Week 7 of Part 2

What was measured

The maximum duration for which a participant continuously maintained a platelet count \>=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Excludes periods from initiation of rescue medication until platelet count falls to below 50Gi/L, irrespective of platelet count

Analysis population: ITT Population, only those participants enrolled in Part 2 were analyzed. The number of participants used to compute the summary statistics reflect the ITT poplation through out the analyses during Part 2.

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 of eltrombopag was 37.5 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, unless otherwise 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-Eltrombopag19
Part 2 (Randomized Period) Cohort 3-Placebo5
Part 2 (Randomized Period) Cohort 3- Eltrombopag10

Reported measurements

Source class 1
Values in Weeks · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 2 (Randomized Period) Cohort 1-Placebo0.0Not reported00Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag1.0Not reported05Not reported
Part 2 (Randomized Period) Cohort 2-Placebo0.0Not reported02Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag2.0Not reported06Not reported
Part 2 (Randomized Period) Cohort 3-Placebo1.0Not reported02Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag1.0Not reported06Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        5
        value
        1.0
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        2
        value
        0.0
      4. group Id
        OG003
        lower Limit
        0
        upper Limit
        6
        value
        2.0
      5. group Id
        OG004
        lower Limit
        0
        upper Limit
        2
        value
        1.0
      6. group Id
        OG005
        lower Limit
        0
        upper Limit
        6
        value
        1.0
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
      19
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      10
    units
    Participants
description
The maximum duration for which a participant continuously maintained a platelet count \>=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Excludes periods from initiation of rescue medication until platelet count falls to below 50Gi/L, irrespective of platelet count
dispersion Type
Full Range
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 of eltrombopag was 37.5 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, unless otherwise 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
MEDIAN
population Description
ITT Population, only those participants enrolled in Part 2 were analyzed. The number of participants used to compute the summary statistics reflect the ITT poplation through out the analyses during Part 2.
reporting Status
POSTED
time Frame
From Baseline through Week 7 of Part 2
title
Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2
type
SECONDARY
unit Of Measure
Weeks

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Preserved source evidence · Not medical advice