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NCT00516321 · OUTCOME

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

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related 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.

Analysis population: ITT Population. Only those participants contributing data at the indicated time points were analyzed. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.

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-2a 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 \>=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a 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 Phase232
Eltrombopag+Antiviral Therapy: DB Phase447

Reported measurements

Baseline, n=208, 387
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase128.00Not reported84.00521.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase133.00Not reported64.00509.00Not reported
Week 1, n=227, 443
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase112.00Not reported30.00398.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase115.00Not reported31.00502.00Not reported
Week 2, n=227, 438
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase79.00Not reported25.00297.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase111.00Not reported36.00596.00Not reported
Week 4, n=218, 430
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase43.50Not reported17.00275.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase90.00Not reported5.00430.00Not reported
Week 6, n=197, 423
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase40.00Not reported12.00261.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase89.00Not reported22.00315.00Not reported
Week 8, n=189, 414
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase41.00Not reported15.00320.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase86.00Not reported22.00249.00Not reported
Week 12, n=165, 404
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase44.00Not reported16.00284.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase91.50Not reported25.00298.00Not reported
Week 16, n=141, 377
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase43.00Not reported16.00280.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase93.00Not reported26.00376.00Not reported
Week 20, n=135, 363
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase44.00Not reported18.00325.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase89.00Not reported25.00339.00Not reported
Week 24, n=89, 248
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase43.00Not reported21.00333.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase92.00Not reported18.00276.00Not reported
Week 28, n=73, 202
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase45.00Not reported22.00345.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase89.50Not reported17.00207.00Not reported
Week 32, n=69, 183
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase44.40Not reported24.00338.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase91.00Not reported21.00406.00Not reported
Week 36, n=68, 173
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase44.50Not reported16.00315.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase91.00Not reported21.00209.00Not reported
Week 40, n=64, 169
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase44.00Not reported22.00276.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase93.00Not reported30.00226.00Not reported
Week 44, n=65, 168
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase48.00Not reported22.00320.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase93.50Not reported27.00238.00Not reported
End of Treatment/Withdrawal, n=212, 419
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase40.00Not reported8.00318.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase90.00Not reported5.00420.00Not reported
Last on Treatment, n=232, 447
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase40.00Not reported8.00318.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase90.00Not reported5.00420.00Not reported
4 Week Follow-Up, n=205, 400
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase54.00Not reported5.00358.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase82.00Not reported5.00304.00Not reported
12 Week Follow-Up, n=196, 396
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase56.00Not reported8.00311.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase67.00Not reported1.00350.00Not reported
24 Week Follow-Up, n=193, 391
Values in Gi/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase56.00Not reported9.00433.00Not reported
Eltrombopag+Antiviral Therapy: DB Phase60.00Not reported7.00340.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        84.00
        upper Limit
        521.00
        value
        128.00
      2. group Id
        OG001
        lower Limit
        64.00
        upper Limit
        509.00
        value
        133.00
    title
    Baseline, n=208, 387
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30.00
        upper Limit
        398.00
        value
        112.00
      2. group Id
        OG001
        lower Limit
        31.00
        upper Limit
        502.00
        value
        115.00
    title
    Week 1, n=227, 443
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        25.00
        upper Limit
        297.00
        value
        79.00
      2. group Id
        OG001
        lower Limit
        36.00
        upper Limit
        596.00
        value
        111.00
    title
    Week 2, n=227, 438
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.00
        upper Limit
        275.00
        value
        43.50
      2. group Id
        OG001
        lower Limit
        5.00
        upper Limit
        430.00
        value
        90.00
    title
    Week 4, n=218, 430
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.00
        upper Limit
        261.00
        value
        40.00
      2. group Id
        OG001
        lower Limit
        22.00
        upper Limit
        315.00
        value
        89.00
    title
    Week 6, n=197, 423
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.00
        upper Limit
        320.00
        value
        41.00
      2. group Id
        OG001
        lower Limit
        22.00
        upper Limit
        249.00
        value
        86.00
    title
    Week 8, n=189, 414
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.00
        upper Limit
        284.00
        value
        44.00
      2. group Id
        OG001
        lower Limit
        25.00
        upper Limit
        298.00
        value
        91.50
    title
    Week 12, n=165, 404
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.00
        upper Limit
        280.00
        value
        43.00
      2. group Id
        OG001
        lower Limit
        26.00
        upper Limit
        376.00
        value
        93.00
    title
    Week 16, n=141, 377
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.00
        upper Limit
        325.00
        value
        44.00
      2. group Id
        OG001
        lower Limit
        25.00
        upper Limit
        339.00
        value
        89.00
    title
    Week 20, n=135, 363
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.00
        upper Limit
        333.00
        value
        43.00
      2. group Id
        OG001
        lower Limit
        18.00
        upper Limit
        276.00
        value
        92.00
    title
    Week 24, n=89, 248
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.00
        upper Limit
        345.00
        value
        45.00
      2. group Id
        OG001
        lower Limit
        17.00
        upper Limit
        207.00
        value
        89.50
    title
    Week 28, n=73, 202
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.00
        upper Limit
        338.00
        value
        44.40
      2. group Id
        OG001
        lower Limit
        21.00
        upper Limit
        406.00
        value
        91.00
    title
    Week 32, n=69, 183
denoms
  1. counts
    1. group Id
      OG000
      value
      232
    2. group Id
      OG001
      value
      447
    units
    Participants
description
Blood taken from peripheral blood vessels was used for the measurement of platelet counts.
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-2a 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 \>=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a 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. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.
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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Preserved source evidence · Not medical advice