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NCT00351468 · OUTCOME

Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication

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

Subjects who achieved maximum platelet count at least once during treatment. All platelet counts after an on-study splenectomy are not classed as responses. Platelet counts within 7 days after a platelet transfusion are not classed as responses. Platelet counts while taking an increased ITP medication or within 6 weeks after the end of an increased ITP medication are not classed as responses.

Analysis population: ITT population

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

Baseline Platelet counts >= 30 Gi/L,
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag91Not reportedNot reportedNot reportedNot reported
Baseline Platelet counts >= 50 Gi/L,
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag42Not reportedNot reportedNot reportedNot reported
Maximum Platelet Count >= 30 Gi/L
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag276Not reportedNot reportedNot reportedNot reported
Maximum Platelet Count >= 50 Gi/L
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag259Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        91
    title
    Baseline Platelet counts >= 30 Gi/L,
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        42
    title
    Baseline Platelet counts >= 50 Gi/L,
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        276
    title
    Maximum Platelet Count >= 30 Gi/L
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        259
    title
    Maximum Platelet Count >= 50 Gi/L
denoms
  1. counts
    1. group Id
      OG000
      value
      302
    units
    Participants
description
Subjects who achieved maximum platelet count at least once during treatment. All platelet counts after an on-study splenectomy are not classed as responses. Platelet counts within 7 days after a platelet transfusion are not classed as responses. Platelet counts while taking an increased ITP medication or within 6 weeks after the end of an increased ITP medication are not classed as responses.
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
population Description
ITT population
reporting Status
POSTED
time Frame
Baseline up to 2 years
title
Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice