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NCT00529568 · OUTCOME

Median Platelet Count at the Indicated Time Points During the DB Phase

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease · Source last updated 2013-11-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Gi/L
Interval / dispersion
Full Range
Time frame
DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

What was measured

Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.

Analysis population: ITT Population. Only those participants contributing data at the indicated time points were analyzed.

Groups in this outcome

Placebo+Antiviral Therapy: DB Phase

Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).

Eltrombopag+Antiviral Therapy: DB Phase

Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).

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

Analysis denominator · Participants

GroupSource count
Placebo+Antiviral Therapy: DB Phase252
Eltrombopag+Antiviral Therapy: DB Phase505

Reported measurements

Baseline, n=238, 460
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase140.0Not reported63365Not reported
Eltrombopag+Antiviral Therapy: DB Phase136.0Not reported43400Not reported
Week 1, n=247, 494
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase120.0Not reported42366Not reported
Eltrombopag+Antiviral Therapy: DB Phase116.0Not reported46466Not reported
Week 2, n=244, 492
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase89.5Not reported27318Not reported
Eltrombopag+Antiviral Therapy: DB Phase124.0Not reported38553Not reported
Week 4, n=228, 487
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase51.0Not reported20180Not reported
Eltrombopag+Antiviral Therapy: DB Phase105Not reported19389Not reported
Week 6, n=206, 473
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase49.5Not reported20200Not reported
Eltrombopag+Antiviral Therapy: DB Phase100.0Not reported22417Not reported
Week 8, n=192, 473
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase50.0Not reported10191Not reported
Eltrombopag+Antiviral Therapy: DB Phase100.0Not reported19486Not reported
Week 12, n=176, 451
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase49.7Not reported21264Not reported
Eltrombopag+Antiviral Therapy: DB Phase104.0Not reported10444Not reported
Week 16, n=145, 405
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase48.0Not reported20262Not reported
Eltrombopag+Antiviral Therapy: DB Phase102.0Not reported13365Not reported
Week 20, n=134, 378
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase50.0Not reported23257Not reported
Eltrombopag+Antiviral Therapy: DB Phase103.0Not reported21373Not reported
Week 24, n=99, 263
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase49.0Not reported19200Not reported
Eltrombopag+Antiviral Therapy: DB Phase102.0Not reported18448Not reported
Week 28, n=74, 212
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase52.5Not reported22193Not reported
Eltrombopag+Antiviral Therapy: DB Phase102.0Not reported20355Not reported
Week 32, n=67, 199
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase49.0Not reported22195Not reported
Eltrombopag+Antiviral Therapy: DB Phase107.0Not reported14295Not reported
Week 36, n=63, 185
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase50.0Not reported16198Not reported
Eltrombopag+Antiviral Therapy: DB Phase106.0Not reported29268Not reported
Week 40, n=58, 174
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase53.7Not reported19195Not reported
Eltrombopag+Antiviral Therapy: DB Phase106.5Not reported10351Not reported
Week 44, n=59, 168
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase53.0Not reported26197Not reported
Eltrombopag+Antiviral Therapy: DB Phase108.7Not reported26330Not reported
End of Treatment/Withdrawal, n=240, 468
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase51.0Not reported10275Not reported
Eltrombopag+Antiviral Therapy: DB Phase106.5Not reported10445Not reported
Last on Treatment, n=253, 505
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase50.0Not reported17300Not reported
Eltrombopag+Antiviral Therapy: DB Phase105.0Not reported10330Not reported
4 week follow up, n=221, 424
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase63.0Not reported4225Not reported
Eltrombopag+Antiviral Therapy: DB Phase89.0Not reported12333Not reported
12 week follow up, n=209, 430
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase57.0Not reported15285Not reported
Eltrombopag+Antiviral Therapy: DB Phase62.0Not reported8280Not reported
24 week follow up, n=201, 395
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase57.0Not reported8231Not reported
Eltrombopag+Antiviral Therapy: DB Phase59.0Not reported4297Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        63
        upper Limit
        365
        value
        140.0
      2. group Id
        OG001
        lower Limit
        43
        upper Limit
        400
        value
        136.0
    title
    Baseline, n=238, 460
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42
        upper Limit
        366
        value
        120.0
      2. group Id
        OG001
        lower Limit
        46
        upper Limit
        466
        value
        116.0
    title
    Week 1, n=247, 494
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27
        upper Limit
        318
        value
        89.5
      2. group Id
        OG001
        lower Limit
        38
        upper Limit
        553
        value
        124.0
    title
    Week 2, n=244, 492
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20
        upper Limit
        180
        value
        51.0
      2. group Id
        OG001
        lower Limit
        19
        upper Limit
        389
        value
        105
    title
    Week 4, n=228, 487
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20
        upper Limit
        200
        value
        49.5
      2. group Id
        OG001
        lower Limit
        22
        upper Limit
        417
        value
        100.0
    title
    Week 6, n=206, 473
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10
        upper Limit
        191
        value
        50.0
      2. group Id
        OG001
        lower Limit
        19
        upper Limit
        486
        value
        100.0
    title
    Week 8, n=192, 473
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21
        upper Limit
        264
        value
        49.7
      2. group Id
        OG001
        lower Limit
        10
        upper Limit
        444
        value
        104.0
    title
    Week 12, n=176, 451
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20
        upper Limit
        262
        value
        48.0
      2. group Id
        OG001
        lower Limit
        13
        upper Limit
        365
        value
        102.0
    title
    Week 16, n=145, 405
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23
        upper Limit
        257
        value
        50.0
      2. group Id
        OG001
        lower Limit
        21
        upper Limit
        373
        value
        103.0
    title
    Week 20, n=134, 378
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19
        upper Limit
        200
        value
        49.0
      2. group Id
        OG001
        lower Limit
        18
        upper Limit
        448
        value
        102.0
    title
    Week 24, n=99, 263
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22
        upper Limit
        193
        value
        52.5
      2. group Id
        OG001
        lower Limit
        20
        upper Limit
        355
        value
        102.0
    title
    Week 28, n=74, 212
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22
        upper Limit
        195
        value
        49.0
      2. group Id
        OG001
        lower Limit
        14
        upper Limit
        295
        value
        107.0
    title
    Week 32, n=67, 199
denoms
  1. counts
    1. group Id
      OG000
      value
      252
    2. group Id
      OG001
      value
      505
    units
    Participants
description
Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.
dispersion Type
Full Range
groups
  1. description
    Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
    id
    OG000
    title
    Placebo+Antiviral Therapy: DB Phase
  2. description
    Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
    id
    OG001
    title
    Eltrombopag+Antiviral Therapy: DB Phase
param Type
MEDIAN
population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
reporting Status
POSTED
time Frame
DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
title
Median Platelet Count at the Indicated Time Points During the DB Phase
type
SECONDARY
unit Of Measure
Gi/L

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