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NCT01520909 · OUTCOME

Number of Participants With a Change in Visual Acuity Since Baseline at Follow-Up Week 24

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
Baseline and Follow-Up Week 24 (Study Week 61)

What was measured

The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Change in visual acuity results are presented as No Change, NCS, Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.

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

No Change
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag63Not reportedNot reportedNot reportedNot reported
NCS
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag12Not reportedNot reportedNot reportedNot reported
Improvement
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag9Not reportedNot reportedNot reportedNot reported
Worsening
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Not Measured
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2 (Open-Label Period) - Eltrombopag1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        63
    title
    No Change
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    NCS
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Improvement
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Worsening
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Not Measured
denoms
  1. counts
    1. group Id
      OG000
      value
      87
    units
    Participants
description
The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Change in visual acuity results are presented as No Change, NCS, Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.
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
Baseline and Follow-Up Week 24 (Study Week 61)
title
Number of Participants With a Change in Visual Acuity Since Baseline at Follow-Up Week 24
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice