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NCT00908037 · OUTCOME

Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline 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 Baseline and post-Baseline up to Study Week 31 of Part 2/3

What was measured

Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.

Analysis population: Safety Population, only those participants enrolled 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

Pre-trt Epithelial Renal Tubular Cell Casts
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 20Not reportedNot reportedNot reportedNot reported
Part 2/3 (Eltrombopag Open- Label Period) Cohort 31Not reportedNot reportedNot reportedNot reported
Pre-trt RBC Casts
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2/3 (Eltrombopag Open-Label Period) Cohort 11Not reportedNot reportedNot reportedNot reported
Part 2/3 (Eltrombopag Open-Label Period) Cohort 20Not reportedNot reportedNot reportedNot reported
Part 2/3 (Eltrombopag Open- Label Period) Cohort 30Not reportedNot reportedNot reportedNot reported
Pre-trt WBC Casts
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2/3 (Eltrombopag Open-Label Period) Cohort 10Not reportedNot reportedNot reportedNot reported
Part 2/3 (Eltrombopag Open-Label Period) Cohort 20Not reportedNot reportedNot reportedNot reported
Part 2/3 (Eltrombopag Open- Label Period) Cohort 30Not reportedNot reportedNot reportedNot reported
Post-BL Epithelial Renal Tubular Cell Casts
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 22Not reportedNot reportedNot reportedNot reported
Part 2/3 (Eltrombopag Open- Label Period) Cohort 31Not reportedNot reportedNot reportedNot reported
Post-BL RBC Casts
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2/3 (Eltrombopag Open-Label Period) Cohort 10Not reportedNot reportedNot reportedNot reported
Part 2/3 (Eltrombopag Open-Label Period) Cohort 20Not reportedNot reportedNot reportedNot reported
Part 2/3 (Eltrombopag Open- Label Period) Cohort 31Not reportedNot reportedNot reportedNot reported
Post-BL WBC Casts
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2/3 (Eltrombopag Open-Label Period) Cohort 11Not reportedNot reportedNot reportedNot reported
Part 2/3 (Eltrombopag Open-Label Period) Cohort 20Not reportedNot reportedNot reportedNot reported
Part 2/3 (Eltrombopag Open- Label Period) Cohort 31Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Pre-trt Epithelial Renal Tubular Cell Casts
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Pre-trt RBC Casts
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Pre-trt WBC Casts
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
    title
    Post-BL Epithelial Renal Tubular Cell Casts
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Post-BL RBC Casts
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Post-BL WBC Casts
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      26
    3. group Id
      OG002
      value
      15
    units
    Participants
description
Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.
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, only those participants enrolled during Part 2/3 were analyzed.
reporting Status
POSTED
time Frame
From Baseline and post-Baseline up to Study Week 31 of Part 2/3
title
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice