Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00351468 · OUTCOME

Summary of Subjects Achieving Platelet Count Levels by Week, 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 Year 7/Week 364

What was measured

If a subject has more than 1 platelet count result within a week, the lowest value observed is used to determine response. 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, n=302
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag91Not reportedNot reportedNot reportedNot reported
Baseline Platelet counts >= 50 Gi/L, n=302
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag42Not reportedNot reportedNot reportedNot reported
Week 1 Platelet Count >= 30 Gi/L n=293
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag172Not reportedNot reportedNot reportedNot reported
Week 1 Platelet Count >= 50 Gi/L n=293
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag127Not reportedNot reportedNot reportedNot reported
Week 2 Platelet Count >= 30 Gi/L n=288
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag199Not reportedNot reportedNot reportedNot reported
Week 2 Platelet Count >= 50 Gi/L n=288
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag165Not reportedNot reportedNot reportedNot reported
Week 3 Platelet Count >= 30 Gi/L n=275
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag192Not reportedNot reportedNot reportedNot reported
Week 3 Platelet Count >= 50 Gi/L n=275
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag159Not reportedNot reportedNot reportedNot reported
Week 4 Platelet Count >= 30 Gi/L n=275
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag192Not reportedNot reportedNot reportedNot reported
Week 4 Platelet Count >= 50 Gi/L n=275
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag149Not reportedNot reportedNot reportedNot reported
Week 5 Platelet Count >= 30 Gi/L n=274
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag197Not reportedNot reportedNot reportedNot reported
Week 5 Platelet Count >= 50 Gi/L n=274
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag159Not reportedNot reportedNot reportedNot reported
Week 6 Platelet Count >= 30 Gi/L n=276
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag203Not reportedNot reportedNot reportedNot reported
Week 6 Platelet Count >= 50 Gi/L n=276
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag169Not reportedNot reportedNot reportedNot reported
Week 12 Platelet Count >= 30 Gi/L n=197
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag147Not reportedNot reportedNot reportedNot reported
Week 12 Platelet Count >= 50 Gi/L n=197
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag120Not reportedNot reportedNot reportedNot reported
Month 6/Week 26 Platelet Count >= 30 Gi/L n=130
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag93Not reportedNot reportedNot reportedNot reported
Month 6/Week 26 Platelet Count >= 50 Gi/L n=130
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag82Not reportedNot reportedNot reportedNot reported
Year 1/Week 52 Platelet Count >= 30 Gi/L n=83
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag62Not reportedNot reportedNot reportedNot reported
Year 1/Week 52 Platelet Count >= 50 Gi/L n=83
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag50Not reportedNot reportedNot reportedNot reported
Year 1.5/Week 78 Platelet Count >= 30 Gi/L n=63
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag47Not reportedNot reportedNot reportedNot reported
Year 1.5/Week78 Platelet Count >= 50 Gi/L n=63
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag41Not reportedNot reportedNot reportedNot reported
Year 2/Week 104 Platelet Count >= 30 Gi/L n=59
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag46Not reportedNot reportedNot reportedNot reported
Year 2/Week 104 Platelet Count >= 50 Gi/L n=59
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag42Not reportedNot reportedNot reportedNot reported
Year 2.5/Week 130 Platelet Count >= 30 Gi/L n=42
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag32Not reportedNot reportedNot reportedNot reported
Year 2.5/Week 130 Platelet Count >= 50 Gi/L n=42
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag28Not reportedNot reportedNot reportedNot reported
Year 3/Week 156 Platelet Count >= 30 Gi/L n=27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag22Not reportedNot reportedNot reportedNot reported
Year 3/Week 156 Platelet Count >= 50 Gi/L n=27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag19Not reportedNot reportedNot reportedNot reported
Year 3.5/Week 182 Platelet Count >= 30 Gi/L n=23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag19Not reportedNot reportedNot reportedNot reported
Year 3.5/Week 182 Platelet Count >= 50 Gi/L n=23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag17Not reportedNot reportedNot reportedNot reported
Year 4/Week 208 Platelet Count >= 30 Gi/L n=17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag12Not reportedNot reportedNot reportedNot reported
Year 4/Week 208 Platelet Count >= 50 Gi/L n=17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag11Not reportedNot reportedNot reportedNot reported
Year 4.5/Week 234 Platelet Count >= 30 Gi/L n=15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag13Not reportedNot reportedNot reportedNot reported
Year 4.5/Week 234 Platelet Count >= 50 Gi/L n=15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag12Not reportedNot reportedNot reportedNot reported
Year 5/Week 260 Platelet Count >= 30 Gi/L n=9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag6Not reportedNot reportedNot reportedNot reported
Year 5/Week 260 Platelet Count >= 50 Gi/L n=9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag6Not reportedNot reportedNot reportedNot reported
Year 5.5/Week 286 Platelet Count >= 30 Gi/L n=9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag7Not reportedNot reportedNot reportedNot reported
Year 5.5/Week 286 Platelet Count >= 50 Gi/L n=9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag7Not reportedNot reportedNot reportedNot reported
Year 6/Week 312 Platelet Count >= 30 Gi/L n=9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag7Not reportedNot reportedNot reportedNot reported
Year 6/Week 312 Platelet Count >= 50 Gi/L n=9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag7Not reportedNot reportedNot reportedNot reported
Year 6.5/Week 338 Platelet Count >= 30 Gi/L n=5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag3Not reportedNot reportedNot reportedNot reported
Year 6.5/Week 338 Platelet Count >= 50 Gi/L n=5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag3Not reportedNot reportedNot reportedNot reported
Year 7/Week 364 Platelet Count >= 30 Gi/L n=3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag3Not reportedNot reportedNot reportedNot reported
Year 7/Week 364 Platelet Count >= 50 Gi/L n=3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Eltrombopag3Not 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, n=302
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        42
    title
    Baseline Platelet counts >= 50 Gi/L, n=302
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        172
    title
    Week 1 Platelet Count >= 30 Gi/L n=293
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        127
    title
    Week 1 Platelet Count >= 50 Gi/L n=293
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        199
    title
    Week 2 Platelet Count >= 30 Gi/L n=288
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        165
    title
    Week 2 Platelet Count >= 50 Gi/L n=288
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        192
    title
    Week 3 Platelet Count >= 30 Gi/L n=275
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        159
    title
    Week 3 Platelet Count >= 50 Gi/L n=275
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        192
    title
    Week 4 Platelet Count >= 30 Gi/L n=275
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        149
    title
    Week 4 Platelet Count >= 50 Gi/L n=275
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        197
    title
    Week 5 Platelet Count >= 30 Gi/L n=274
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        159
    title
    Week 5 Platelet Count >= 50 Gi/L n=274
denoms
  1. counts
    1. group Id
      OG000
      value
      302
    units
    Participants
description
If a subject has more than 1 platelet count result within a week, the lowest value observed is used to determine response. 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 Year 7/Week 364
title
Summary of Subjects Achieving Platelet Count Levels by Week, 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