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NCT00529568 · OUTCOME

Mean Change From Baseline in Body Mass Index (BMI) 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 per meters squared (kg/m^2)
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 BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. 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 Phase493

Reported measurements

Week 1, n=248, 490
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.230.771Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.230.713Not reportedNot reportedNot reported
Week 2, n=244, 493
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.310.691Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.360.921Not reportedNot reportedNot reported
Week 4, n=229, 486
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.460.823Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.450.855Not reportedNot reportedNot reported
Week 6, n=207, 474
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.500.871Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.580.893Not reportedNot reportedNot reported
Week 8, n=191, 471
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.660.967Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.730.955Not reportedNot reportedNot reported
Week 12, n=175, 451
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.771.055Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.971.167Not reportedNot reportedNot reported
Week 16, n=145, 404
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.851.158Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.151.285Not reportedNot reportedNot reported
Week 20, n=134, 376
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.111.324Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.391.377Not reportedNot reportedNot reported
Week 24, n=99, 264
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.461.509Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.661.624Not reportedNot reportedNot reported
Week 28, n=74, 211
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.671.731Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.791.733Not reportedNot reportedNot reported
Week 32, n=67, 199
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.641.586Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.941.844Not reportedNot reportedNot reported
Week 36, n=63, 187
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.651.703Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.892.651Not reportedNot reportedNot reported
Week 40, n=59, 173
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.811.671Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.091.953Not reportedNot reportedNot reported
Week 44, n=59, 167
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.732.007Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.091.942Not reportedNot reportedNot reported
End of Treatment, n=240, 468
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.161.553Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.641.783Not reportedNot reportedNot reported
4-week FU, n=223, 423
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.981.519Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.352.306Not reportedNot reportedNot reported
12-week FU, n=210, 432
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.701.434Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.062.055Not reportedNot reportedNot reported
24-week FU, n=205, 399
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.471.544Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.532.736Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.771
        value
        -0.23
      2. group Id
        OG001
        spread
        0.713
        value
        -0.23
    title
    Week 1, n=248, 490
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.691
        value
        -0.31
      2. group Id
        OG001
        spread
        0.921
        value
        -0.36
    title
    Week 2, n=244, 493
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.823
        value
        -0.46
      2. group Id
        OG001
        spread
        0.855
        value
        -0.45
    title
    Week 4, n=229, 486
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.871
        value
        -0.50
      2. group Id
        OG001
        spread
        0.893
        value
        -0.58
    title
    Week 6, n=207, 474
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.967
        value
        -0.66
      2. group Id
        OG001
        spread
        0.955
        value
        -0.73
    title
    Week 8, n=191, 471
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.055
        value
        -0.77
      2. group Id
        OG001
        spread
        1.167
        value
        -0.97
    title
    Week 12, n=175, 451
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.158
        value
        -0.85
      2. group Id
        OG001
        spread
        1.285
        value
        -1.15
    title
    Week 16, n=145, 404
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.324
        value
        -1.11
      2. group Id
        OG001
        spread
        1.377
        value
        -1.39
    title
    Week 20, n=134, 376
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.509
        value
        -1.46
      2. group Id
        OG001
        spread
        1.624
        value
        -1.66
    title
    Week 24, n=99, 264
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.731
        value
        -1.67
      2. group Id
        OG001
        spread
        1.733
        value
        -1.79
    title
    Week 28, n=74, 211
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.586
        value
        -1.64
      2. group Id
        OG001
        spread
        1.844
        value
        -1.94
    title
    Week 32, n=67, 199
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.703
        value
        -1.65
      2. group Id
        OG001
        spread
        2.651
        value
        -1.89
    title
    Week 36, n=63, 187
denoms
  1. counts
    1. group Id
      OG000
      value
      248
    2. group Id
      OG001
      value
      493
    units
    Participants
description
The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. 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 Body Mass Index (BMI) at the Indicated Time Points During the DB Phase
type
SECONDARY
unit Of Measure
Kilograms per meters squared (kg/m^2)

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Preserved source evidence · Not medical advice