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NCT00529568 · OUTCOME

Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) 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
Millimeters of mercury (mmHg)
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

Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. 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 Phase246
Eltrombopag+Antiviral Therapy: DB Phase494

Reported measurements

SBP, Week 1, n=246, 491
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.0013.541Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.3612.296Not reportedNot reportedNot reported
SBP, Week 2, n=242, 494
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.2513.800Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.7413.122Not reportedNot reportedNot reported
SBP, Week 4, n=228, 485
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.7513.781Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.9113.780Not reportedNot reportedNot reported
SBP, Week 6, n=206, 471
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.3614.405Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.8514.624Not reportedNot reportedNot reported
SBP, Week 8, n=190, 472
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.7214.073Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.3314.401Not reportedNot reportedNot reported
SBP, Week 12, n=175, 452
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.1615.297Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.3014.377Not reportedNot reportedNot reported
SBP, Week 16, n=143, 403
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.1615.426Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.5913.579Not reportedNot reportedNot reported
SBP, Week 20, n=133, 374
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.5014.387Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.1214.908Not reportedNot reportedNot reported
SBP, Week 24, n=99, 263
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.9714.820Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.9414.917Not reportedNot reportedNot reported
SBP, Week 28, n=74, 211
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.6914.663Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.9914.557Not reportedNot reportedNot reported
SBP, Week 32, n=67, 197
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.4613.904Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-5.6113.523Not reportedNot reportedNot reported
SBP, Week 36, n=62, 186
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.3113.803Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.4014.842Not reportedNot reportedNot reported
SBP, Week 40, n=59, 173
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0.1013.605Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.3113.941Not reportedNot reportedNot reported
SBP, Week 44, n=59, 167
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0.5611.689Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-4.5413.794Not reportedNot reportedNot reported
SBP, End of Treatment, n=238, 468
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.0313.259Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.9815.318Not reportedNot reportedNot reported
SBP, 4-week FU, n=221, 426
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.1414.095Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.6515.122Not reportedNot reportedNot reported
SBP, 12-week FU, n=207, 432
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.1114.113Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.8614.806Not reportedNot reportedNot reported
SBP, 24-week FU, n=203, 398
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase1.1014.545Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase0.2514.518Not reportedNot reportedNot reported
DBP, Week 1, n=246, 491
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.439.235Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.378.224Not reportedNot reportedNot reported
DBP, Week 2, n=242, 493
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.559.217Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.868.946Not reportedNot reportedNot reported
DBP, Week 4, n=228, 485
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.849.726Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.729.467Not reportedNot reportedNot reported
DBP, Week 6, n=206, 471
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.168.939Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.959.859Not reportedNot reportedNot reported
DBP, Week 8, n=190, 472
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.249.517Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.689.901Not reportedNot reportedNot reported
DBP, Week 12, n=175, 452
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.318.781Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.2310.025Not reportedNot reportedNot reported
DBP, Week 16, n=143, 403
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.549.684Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.319.899Not reportedNot reportedNot reported
DBP, Week 20, n=133, 374
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.9310.582Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.089.606Not reportedNot reportedNot reported
DBP, Week 24, n=99, 263
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.6610.207Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.549.313Not reportedNot reportedNot reported
DBP, Week 28, n=74, 211
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.239.538Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.4210.502Not reportedNot reportedNot reported
DBP, Week 32, n=67, 197
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.5410.445Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.769.527Not reportedNot reportedNot reported
DBP, Week 36, n=62, 186
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.749.559Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.599.211Not reportedNot reportedNot reported
DBP, Week 40, n=59, 173
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0.349.343Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.329.517Not reportedNot reportedNot reported
DBP, Week 44, n=59, 167
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0.929.033Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.7710.134Not reportedNot reportedNot reported
DBP, End of Treatment, n=238, 468
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.559.174Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.5910.254Not reportedNot reportedNot reported
DBP, 4-week FU, n=221, 426
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.839.102Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.209.824Not reportedNot reportedNot reported
DBP, 12-week FU, n=207, 432
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.7810.253Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.769.903Not reportedNot reportedNot reported
DBP, 24-week FU, n=203, 398
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0.039.814Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.619.339Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.541
        value
        -3.00
      2. group Id
        OG001
        spread
        12.296
        value
        -2.36
    title
    SBP, Week 1, n=246, 491
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.800
        value
        -3.25
      2. group Id
        OG001
        spread
        13.122
        value
        -3.74
    title
    SBP, Week 2, n=242, 494
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.781
        value
        -3.75
      2. group Id
        OG001
        spread
        13.780
        value
        -3.91
    title
    SBP, Week 4, n=228, 485
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.405
        value
        -3.36
      2. group Id
        OG001
        spread
        14.624
        value
        -3.85
    title
    SBP, Week 6, n=206, 471
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.073
        value
        -2.72
      2. group Id
        OG001
        spread
        14.401
        value
        -4.33
    title
    SBP, Week 8, n=190, 472
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.297
        value
        -2.16
      2. group Id
        OG001
        spread
        14.377
        value
        -4.30
    title
    SBP, Week 12, n=175, 452
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.426
        value
        -3.16
      2. group Id
        OG001
        spread
        13.579
        value
        -4.59
    title
    SBP, Week 16, n=143, 403
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.387
        value
        -2.50
      2. group Id
        OG001
        spread
        14.908
        value
        -4.12
    title
    SBP, Week 20, n=133, 374
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.820
        value
        -1.97
      2. group Id
        OG001
        spread
        14.917
        value
        -3.94
    title
    SBP, Week 24, n=99, 263
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.663
        value
        -0.69
      2. group Id
        OG001
        spread
        14.557
        value
        -4.99
    title
    SBP, Week 28, n=74, 211
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.904
        value
        -1.46
      2. group Id
        OG001
        spread
        13.523
        value
        -5.61
    title
    SBP, Week 32, n=67, 197
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.803
        value
        -1.31
      2. group Id
        OG001
        spread
        14.842
        value
        -4.40
    title
    SBP, Week 36, n=62, 186
denoms
  1. counts
    1. group Id
      OG000
      value
      246
    2. group Id
      OG001
      value
      494
    units
    Participants
description
Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. 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 Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase
type
SECONDARY
unit Of Measure
Millimeters of mercury (mmHg)

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Preserved source evidence · Not medical advice