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NCT00516321 · 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 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
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-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 Phase231
Eltrombopag+Antiviral Therapy: DB Phase444

Reported measurements

SBP, Week 1, n=231, 443
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.313.66Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.713.48Not reportedNot reportedNot reported
SBP, Week 2, n=227, 437
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-5.013.75Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.214.05Not reportedNot reportedNot reported
SBP, Week 4, n=218, 429
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-6.113.61Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.713.63Not reportedNot reportedNot reported
SBP, Week 6, n=196, 420
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-4.314.00Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.913.86Not reportedNot reportedNot reported
SBP, Week 8, n=190, 416
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.614.04Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.914.15Not reportedNot reportedNot reported
SBP, Week 12, n=165, 405
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-4.013.17Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.614.07Not reportedNot reportedNot reported
SBP, Week 16, n=140, 376
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-4.213.69Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.813.88Not reportedNot reportedNot reported
SBP, Week 20, n=135, 363
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-4.115.09Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.214.84Not reportedNot reportedNot reported
SBP, Week 24, n=88, 249
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.715.88Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.915.88Not reportedNot reportedNot reported
SBP, Week 28, n=74, 202
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.012.79Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.316.62Not reportedNot reportedNot reported
SBP, Week 32, n=68, 183
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.111.95Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.616.12Not reportedNot reportedNot reported
SBP, Week 36, n=68, 175
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.413.73Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.016.43Not reportedNot reportedNot reported
SBP, Week 40, n=64, 169
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.711.95Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.416.47Not reportedNot reportedNot reported
SBP, Week 44, n=64, 166
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.512.98Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.816.76Not reportedNot reportedNot reported
SBP, End of Treatment, n=213, 420
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.814.94Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.115.65Not reportedNot reportedNot reported
SBP, 4-week FU, n=204, 402
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.713.95Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.216.23Not reportedNot reportedNot reported
SBP, 12-week FU, n=198, 401
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.414.24Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.715.68Not reportedNot reportedNot reported
SBP, 24-week FU, n=197, 394
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.114.04Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase0.116.02Not reportedNot reportedNot reported
DBP, Week 1, n=231, 443
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.39.57Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.59.21Not reportedNot reportedNot reported
DBP, Week 2, n=227, 437
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.610.05Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.89.11Not reportedNot reportedNot reported
DBP, Week 4, n=218, 429
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.210.01Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.310.12Not reportedNot reportedNot reported
DBP, Week 6, n=196, 420
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.99.13Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.19.69Not reportedNot reportedNot reported
DBP, Week 8, n=190, 416
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.79.67Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.610.03Not reportedNot reportedNot reported
DBP, Week 12, n=165, 405
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.09.92Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.810.05Not reportedNot reportedNot reported
DBP, Week 16, n=140, 376
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.49.19Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.110.01Not reportedNot reportedNot reported
DBP, Week 20, n=135, 363
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.510.04Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.49.59Not reportedNot reportedNot reported
DBP, Week 24, n=88, 249
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.410.60Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.99.95Not reportedNot reportedNot reported
DBP, Week 28, n=74, 202
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-3.710.32Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.010.43Not reportedNot reportedNot reported
DBP, Week 32, n=68, 183
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.710.93Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.59.99Not reportedNot reportedNot reported
DBP, Week 36, n=68, 175
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.511.51Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.19.84Not reportedNot reportedNot reported
DBP, Week 40, n=64, 169
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.710.65Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.910.99Not reportedNot reportedNot reported
DBP, Week 44, n=64, 166
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.810.96Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-3.210.54Not reportedNot reportedNot reported
DBP, End of Treatment, n=213, 420
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-2.810.07Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-2.810.26Not reportedNot reportedNot reported
DBP, 4-week FU, n=204, 402
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.89.30Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.210.67Not reportedNot reportedNot reported
DBP, 12-week FU, n=198, 401
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-1.410.48Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.910.09Not reportedNot reportedNot reported
DBP, 24-week FU, n=197, 394
Values in Millimeters of mercury (mmHg) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase-0.69.90Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.39.97Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.66
        value
        -3.3
      2. group Id
        OG001
        spread
        13.48
        value
        -2.7
    title
    SBP, Week 1, n=231, 443
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.75
        value
        -5.0
      2. group Id
        OG001
        spread
        14.05
        value
        -3.2
    title
    SBP, Week 2, n=227, 437
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.61
        value
        -6.1
      2. group Id
        OG001
        spread
        13.63
        value
        -3.7
    title
    SBP, Week 4, n=218, 429
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.00
        value
        -4.3
      2. group Id
        OG001
        spread
        13.86
        value
        -3.9
    title
    SBP, Week 6, n=196, 420
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.04
        value
        -3.6
      2. group Id
        OG001
        spread
        14.15
        value
        -3.9
    title
    SBP, Week 8, n=190, 416
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.17
        value
        -4.0
      2. group Id
        OG001
        spread
        14.07
        value
        -3.6
    title
    SBP, Week 12, n=165, 405
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.69
        value
        -4.2
      2. group Id
        OG001
        spread
        13.88
        value
        -3.8
    title
    SBP, Week 16, n=140, 376
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.09
        value
        -4.1
      2. group Id
        OG001
        spread
        14.84
        value
        -3.2
    title
    SBP, Week 20, n=135, 363
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.88
        value
        -3.7
      2. group Id
        OG001
        spread
        15.88
        value
        -2.9
    title
    SBP, Week 24, n=88, 249
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.79
        value
        -3.0
      2. group Id
        OG001
        spread
        16.62
        value
        -3.3
    title
    SBP, Week 28, n=74, 202
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.95
        value
        -3.1
      2. group Id
        OG001
        spread
        16.12
        value
        -2.6
    title
    SBP, Week 32, n=68, 183
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.73
        value
        -2.4
      2. group Id
        OG001
        spread
        16.43
        value
        -3.0
    title
    SBP, Week 36, n=68, 175
denoms
  1. counts
    1. group Id
      OG000
      value
      231
    2. group Id
      OG001
      value
      444
    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-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 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