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NCT00351468 · OUTCOME

Maximum ITP Bleeding Score at Any Time During the Study During All Stages.

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

The ITP bleeding score is a tool which has been designed specifically to assess the bruising and bleeding in patients with ITP across body sites, ranging from mild to severe. The WHO Grades were dichotomized into the following categories: - Grade 0, No bleeding -Grade 1 to 4, Any bleeding -Grade 0 to 1: No clinically significant bleeding -Grade 2 to 4 Clinically significant bleeding

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

Epistaxis n=300 Grade 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag204Not reportedNot reportedNot reportedNot reported
Epistaxis n=300 Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag65Not reportedNot reportedNot reportedNot reported
Epistaxis n=300 Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag31Not reportedNot reportedNot reportedNot reported
Gastrointestinal n=300 Grade 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag264Not reportedNot reportedNot reportedNot reported
Gastrointestinal n=300 Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag26Not reportedNot reportedNot reportedNot reported
Gastrointestinal n=300 Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag10Not reportedNot reportedNot reportedNot reported
Genitourinary n=300 Grade 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag262Not reportedNot reportedNot reportedNot reported
Genitourinary n=300 Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag29Not reportedNot reportedNot reportedNot reported
Genitourinary n=300 Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag9Not reportedNot reportedNot reportedNot reported
Gynecologic n=108 Grade 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag68Not reportedNot reportedNot reportedNot reported
Gynecologic n=108 Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag15Not reportedNot reportedNot reportedNot reported
Gynecologic n=108 Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag25Not reportedNot reportedNot reportedNot reported
Intracerebral hemorrhage n=300 Grade 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag297Not reportedNot reportedNot reportedNot reported
Intracerebral hemorrhage n=300 Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag3Not reportedNot reportedNot reportedNot reported
Intracerebral hemorrhage n=300 Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag0Not reportedNot reportedNot reportedNot reported
Ocular n=300 Grade 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag258Not reportedNot reportedNot reportedNot reported
Ocular n=300 Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag37Not reportedNot reportedNot reportedNot reported
Ocular n=300 Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag5Not reportedNot reportedNot reportedNot reported
Oral n=300 Grade 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag191Not reportedNot reportedNot reportedNot reported
Oral n=300 Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag81Not reportedNot reportedNot reportedNot reported
Oral n=300 Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag28Not reportedNot reportedNot reportedNot reported
Pulmonary n=300 Grade 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag287Not reportedNot reportedNot reportedNot reported
Pulmonary n=300 Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag13Not reportedNot reportedNot reportedNot reported
Pulmonary n=300 Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag0Not reportedNot reportedNot reportedNot reported
Skin, ecchymosis n=300 Grade 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag74Not reportedNot reportedNot reportedNot reported
Skin, ecchymosis n=300 Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag159Not reportedNot reportedNot reportedNot reported
Skin, ecchymosis n=300 Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag67Not reportedNot reportedNot reportedNot reported
Skin, petechiae n=300 Grade 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag142Not reportedNot reportedNot reportedNot reported
Skin, petechiae n=300 Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag126Not reportedNot reportedNot reportedNot reported
Skin, petechiae n=300 Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag32Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        204
    title
    Epistaxis n=300 Grade 0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        65
    title
    Epistaxis n=300 Grade 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        31
    title
    Epistaxis n=300 Grade 2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        264
    title
    Gastrointestinal n=300 Grade 0
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        26
    title
    Gastrointestinal n=300 Grade 1
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Gastrointestinal n=300 Grade 2
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        262
    title
    Genitourinary n=300 Grade 0
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    title
    Genitourinary n=300 Grade 1
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Genitourinary n=300 Grade 2
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        68
    title
    Gynecologic n=108 Grade 0
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    Gynecologic n=108 Grade 1
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    Gynecologic n=108 Grade 2
denoms
  1. counts
    1. group Id
      OG000
      value
      302
    units
    Participants
description
The ITP bleeding score is a tool which has been designed specifically to assess the bruising and bleeding in patients with ITP across body sites, ranging from mild to severe. The WHO Grades were dichotomized into the following categories: - Grade 0, No bleeding -Grade 1 to 4, Any bleeding -Grade 0 to 1: No clinically significant bleeding -Grade 2 to 4 Clinically significant bleeding
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
Maximum ITP Bleeding Score at Any Time During the Study During All Stages.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice