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NCT00529568 · OUTCOME

Mean Change From Baseline in Weight 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
MEAN
Unit
Kilograms (kg)
Interval / dispersion
Standard Deviation
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

The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Analysis population: Safety DB 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 Phase248
Eltrombopag+Antiviral Therapy: DB Phase495

Reported measurements

Week 1, n=248, 492
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.652.201Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.682.062Not reportedNot reportedNot reported
Week 2, n=244, 495
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.881.983Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.062.809Not reportedNot reportedNot reported
Week 4, n=229, 488
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.302.374Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.302.488Not reportedNot reportedNot reported
Week 6, n=207, 476
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.422.464Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.682.652Not reportedNot reportedNot reported
Week 8, n=191, 473
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.892.793Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.112.810Not reportedNot reportedNot reported
Week 12, n=175, 453
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.182.985Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.833.440Not reportedNot reportedNot reported
Week 16, n=145, 406
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.373.247Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.323.798Not reportedNot reportedNot reported
Week 20, n=134, 378
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.083.684Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.994.040Not reportedNot reportedNot reported
Week 24, n=99, 265
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-4.044.148Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.754.175Not reportedNot reportedNot reported
Week 28, n=74, 212
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-4.574.749Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-5.095.016Not reportedNot reportedNot reported
Week 32, n=67, 200
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-4.504.397Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-5.525.369Not reportedNot reportedNot reported
Week 36, n=63, 188
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-4.544.739Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-5.397.476Not reportedNot reportedNot reported
Week 40, n=59, 174
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-4.994.612Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-5.875.571Not reportedNot reportedNot reported
Week 44, n=59, 168
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-4.795.475Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-5.895.661Not reportedNot reportedNot reported
End of Treatment, n=240, 470
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.284.361Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.695.180Not reportedNot reportedNot reported
4-week FU, n=223, 425
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.784.318Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.846.381Not reportedNot reportedNot reported
12-week FU, n=210, 434
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.984.088Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.995.999Not reportedNot reportedNot reported
24-week FU, n=205, 401
Values in Kilograms (kg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.364.568Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.517.683Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.201
        value
        -0.65
      2. group Id
        OG001
        spread
        2.062
        value
        -0.68
    title
    Week 1, n=248, 492
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.983
        value
        -0.88
      2. group Id
        OG001
        spread
        2.809
        value
        -1.06
    title
    Week 2, n=244, 495
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.374
        value
        -1.30
      2. group Id
        OG001
        spread
        2.488
        value
        -1.30
    title
    Week 4, n=229, 488
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.464
        value
        -1.42
      2. group Id
        OG001
        spread
        2.652
        value
        -1.68
    title
    Week 6, n=207, 476
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.793
        value
        -1.89
      2. group Id
        OG001
        spread
        2.810
        value
        -2.11
    title
    Week 8, n=191, 473
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.985
        value
        -2.18
      2. group Id
        OG001
        spread
        3.440
        value
        -2.83
    title
    Week 12, n=175, 453
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.247
        value
        -2.37
      2. group Id
        OG001
        spread
        3.798
        value
        -3.32
    title
    Week 16, n=145, 406
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.684
        value
        -3.08
      2. group Id
        OG001
        spread
        4.040
        value
        -3.99
    title
    Week 20, n=134, 378
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.148
        value
        -4.04
      2. group Id
        OG001
        spread
        4.175
        value
        -4.75
    title
    Week 24, n=99, 265
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.749
        value
        -4.57
      2. group Id
        OG001
        spread
        5.016
        value
        -5.09
    title
    Week 28, n=74, 212
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.397
        value
        -4.50
      2. group Id
        OG001
        spread
        5.369
        value
        -5.52
    title
    Week 32, n=67, 200
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.739
        value
        -4.54
      2. group Id
        OG001
        spread
        7.476
        value
        -5.39
    title
    Week 36, n=63, 188
denoms
  1. counts
    1. group Id
      OG000
      value
      248
    2. group Id
      OG001
      value
      495
    units
    Participants
description
The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
dispersion Type
Standard Deviation
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
MEAN
population Description
Safety DB 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
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase
type
SECONDARY
unit Of Measure
Kilograms (kg)

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Preserved source evidence · Not medical advice