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NCT00351468 · OUTCOME

Number of Participants With Reduction and/or Sparing of Concomitant ITP Therapies, While Maintaining a Platelet Count ≥ 50,000/mL.

EXTEND (Eltrombopag Extended Dosing Study) · Source last updated 2017-04-17

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 up to 2 years

What was measured

Sustain reduct: Sustained reduction 1 Denominator is number of subjects taking an ITP medication at baseline. 2 Denominator is number of subjects with a sustained reduction. Note: Sustained reduction defined as reduction from baseline in dose and/or frequency which is maintained for at least 4 weeks. Excludes sustained reductions started more than 1 day after last dose.

Groups in this outcome

Eltrombopag

Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Eltrombopag302

Reported measurements

ITP medication at baseline
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag101Not reportedNot reportedNot reportedNot reported
Sustain reduct or stop at least 1 med [1] n=101
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag71Not reportedNot reportedNot reportedNot reported
Permanently stopping at least 1 ITP med [1] n=101
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag53Not reportedNot reportedNot reportedNot reported
Sustained reduction[1] n=101
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag70Not reportedNot reportedNot reportedNot reported
Maximum sustained reduction ≥ 24 weeks[2] n=70
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag66Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        101
    title
    ITP medication at baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        71
    title
    Sustain reduct or stop at least 1 med [1] n=101
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        53
    title
    Permanently stopping at least 1 ITP med [1] n=101
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        70
    title
    Sustained reduction[1] n=101
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        66
    title
    Maximum sustained reduction ≥ 24 weeks[2] n=70
denoms
  1. counts
    1. group Id
      OG000
      value
      302
    units
    Participants
description
Sustain reduct: Sustained reduction 1 Denominator is number of subjects taking an ITP medication at baseline. 2 Denominator is number of subjects with a sustained reduction. Note: Sustained reduction defined as reduction from baseline in dose and/or frequency which is maintained for at least 4 weeks. Excludes sustained reductions started more than 1 day after last dose.
groups
  1. description
    Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
    id
    OG000
    title
    Eltrombopag
param Type
NUMBER
reporting Status
POSTED
time Frame
Baseline up to 2 years
title
Number of Participants With Reduction and/or Sparing of Concomitant ITP Therapies, While Maintaining a Platelet Count ≥ 50,000/mL.
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice