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NCT00516321 · 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 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
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-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 Phase228
Eltrombopag+Antiviral Therapy: DB Phase440

Reported measurements

Week 1, n=228, 440
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.20.61Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.20.61Not reportedNot reportedNot reported
Week 2, n=225, 436
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.20.67Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.30.65Not reportedNot reportedNot reported
Week 4, n=216, 427
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.30.72Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.40.84Not reportedNot reportedNot reported
Week 6, n=196, 418
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.40.78Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.40.80Not reportedNot reportedNot reported
Week 8, n=189, 413
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.40.89Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.60.92Not reportedNot reportedNot reported
Week 12, n=164, 401
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.51.11Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.81.09Not reportedNot reportedNot reported
Week 16, n=138, 375
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.71.10Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.01.14Not reportedNot reportedNot reported
Week 20, n=134, 362
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.71.24Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.21.27Not reportedNot reportedNot reported
Week 24, n=87, 248
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.61.19Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.51.42Not reportedNot reportedNot reported
Week 28, n=73, 201
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.91.63Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.61.42Not reportedNot reportedNot reported
Week 32, n=68, 183
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.71.25Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.51.46Not reportedNot reportedNot reported
Week 36, n=67, 174
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.71.30Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.61.51Not reportedNot reportedNot reported
Week 40, n=63, 169
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.71.42Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.61.59Not reportedNot reportedNot reported
Week 44, n=64, 166
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.81.53Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.71.61Not reportedNot reportedNot reported
End of Treatment, n=212, 416
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.71.33Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.51.66Not reportedNot reportedNot reported
4-week FU, n=202, 402
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.71.37Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.31.66Not reportedNot reportedNot reported
12-week FU, n=196, 398
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.51.54Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.01.79Not reportedNot reportedNot reported
24-week FU, n=195, 390
Values in Kilograms per meters squared (kg/m^2) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.31.81Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.61.78Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.61
        value
        -0.2
      2. group Id
        OG001
        spread
        0.61
        value
        -0.2
    title
    Week 1, n=228, 440
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.67
        value
        -0.2
      2. group Id
        OG001
        spread
        0.65
        value
        -0.3
    title
    Week 2, n=225, 436
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.72
        value
        -0.3
      2. group Id
        OG001
        spread
        0.84
        value
        -0.4
    title
    Week 4, n=216, 427
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.78
        value
        -0.4
      2. group Id
        OG001
        spread
        0.80
        value
        -0.4
    title
    Week 6, n=196, 418
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.89
        value
        -0.4
      2. group Id
        OG001
        spread
        0.92
        value
        -0.6
    title
    Week 8, n=189, 413
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.11
        value
        -0.5
      2. group Id
        OG001
        spread
        1.09
        value
        -0.8
    title
    Week 12, n=164, 401
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.10
        value
        -0.7
      2. group Id
        OG001
        spread
        1.14
        value
        -1.0
    title
    Week 16, n=138, 375
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.24
        value
        -0.7
      2. group Id
        OG001
        spread
        1.27
        value
        -1.2
    title
    Week 20, n=134, 362
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.19
        value
        -0.6
      2. group Id
        OG001
        spread
        1.42
        value
        -1.5
    title
    Week 24, n=87, 248
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.63
        value
        -0.9
      2. group Id
        OG001
        spread
        1.42
        value
        -1.6
    title
    Week 28, n=73, 201
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.25
        value
        -0.7
      2. group Id
        OG001
        spread
        1.46
        value
        -1.5
    title
    Week 32, n=68, 183
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.30
        value
        -0.7
      2. group Id
        OG001
        spread
        1.51
        value
        -1.6
    title
    Week 36, n=67, 174
denoms
  1. counts
    1. group Id
      OG000
      value
      228
    2. group Id
      OG001
      value
      440
    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-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
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