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NCT01520909 · OUTCOME

Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During Part 2

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 Baseline up to Week 24 of Part 2 and Follow-up Weeks 1 to 4 (up to Study Week 41)

What was measured

Hematology parameters were summarized according to the NCI CTCAE, version 4.0: G0, none, G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: leukocytes, neutrophils, hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), and lymphocytes (decreased). For participants randomized to Placebo in Part 1, the BL value for Part 2 is defined as the value taken at Week 13 of Part 1. For participants randomized to Eltrombopag in Part 1, the BL value is defined as the value taken on Day 1 or, if missing, the latest non-missing Screening value. For participants who do not have both a Screening and Day 1 value, the Screening or Day 1 value will be used as BL. The maximum post-BL toxicity grade includes any scheduled or unscheduled post-BL assessment.

Analysis population: Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.

Groups in this outcome

Part 2 (Open-Label Period) - Eltrombopag

Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: 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 and; 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 2 (Open-Label Period) - Eltrombopag87

Reported measurements

Leukocytes, G0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag59Not reportedNot reportedNot reportedNot reported
Leukocytes, G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag23Not reportedNot reportedNot reportedNot reported
Leukocytes, G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Leukocytes, G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Leukocytes, G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag0Not reportedNot reportedNot reportedNot reported
Neutrophils, G0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag63Not reportedNot reportedNot reportedNot reported
Neutrophils, G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag6Not reportedNot reportedNot reportedNot reported
Neutrophils, G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag13Not reportedNot reportedNot reportedNot reported
Neutrophils, G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Neutrophils, G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Hemoglobin (increased), G0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag74Not reportedNot reportedNot reportedNot reported
Hemoglobin (increased), G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag11Not reportedNot reportedNot reportedNot reported
Hemoglobin (increased), G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Hemoglobin (increased), G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag0Not reportedNot reportedNot reportedNot reported
Hemoglobin (increased), G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag0Not reportedNot reportedNot reportedNot reported
Hemoglobin (anemia), G0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag48Not reportedNot reportedNot reportedNot reported
Hemoglobin (anemia), G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag31Not reportedNot reportedNot reportedNot reported
Hemoglobin (anemia), G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag7Not reportedNot reportedNot reportedNot reported
Hemoglobin (anemia), G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag1Not reportedNot reportedNot reportedNot reported
Hemoglobin (anemia), G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag0Not reportedNot reportedNot reportedNot reported
Lymphocytes (increased), G0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag47Not reportedNot reportedNot reportedNot reported
Lymphocytes (increased), G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag0Not reportedNot reportedNot reportedNot reported
Lymphocytes (increased), G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag40Not reportedNot reportedNot reportedNot reported
Lymphocytes (increased), G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag0Not reportedNot reportedNot reportedNot reported
Lymphocytes (increased), G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag0Not reportedNot reportedNot reportedNot reported
Lymphocytes (decreased), G0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag65Not reportedNot reportedNot reportedNot reported
Lymphocytes (decreased), G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag19Not reportedNot reportedNot reportedNot reported
Lymphocytes (decreased), G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Lymphocytes (decreased), G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag1Not reportedNot reportedNot reportedNot reported
Lymphocytes (decreased), G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        59
    title
    Leukocytes, G0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    title
    Leukocytes, G1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Leukocytes, G2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Leukocytes, G3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Leukocytes, G4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        63
    title
    Neutrophils, G0
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Neutrophils, G1
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Neutrophils, G2
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Neutrophils, G3
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Neutrophils, G4
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        74
    title
    Hemoglobin (increased), G0
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Hemoglobin (increased), G1
denoms
  1. counts
    1. group Id
      OG000
      value
      87
    units
    Participants
description
Hematology parameters were summarized according to the NCI CTCAE, version 4.0: G0, none, G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: leukocytes, neutrophils, hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), and lymphocytes (decreased). For participants randomized to Placebo in Part 1, the BL value for Part 2 is defined as the value taken at Week 13 of Part 1. For participants randomized to Eltrombopag in Part 1, the BL value is defined as the value taken on Day 1 or, if missing, the latest non-missing Screening value. For participants who do not have both a Screening and Day 1 value, the Screening or Day 1 value will be used as BL. The maximum post-BL toxicity grade includes any scheduled or unscheduled post-BL assessment.
groups
  1. description
    Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: 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 and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
    id
    OG000
    title
    Part 2 (Open-Label Period) - Eltrombopag
param Type
NUMBER
population Description
Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.
reporting Status
POSTED
time Frame
From Baseline up to Week 24 of Part 2 and Follow-up Weeks 1 to 4 (up to Study Week 41)
title
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During Part 2
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice