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NCT00529568 · OUTCOME

Mean Change From Baseline in Heart Rate 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
beats per minute
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

Heart rate was measured in participants 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 Phase244
Eltrombopag+Antiviral Therapy: DB Phase490

Reported measurements

Week 1, n=244, 490
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase1.168.358Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-0.438.629Not reportedNot reportedNot reported
Week 2, n=242, 490
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase1.898.510Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase0.789.644Not reportedNot reportedNot reported
Week 4, n=227, 483
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase2.479.464Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase1.509.739Not reportedNot reportedNot reported
Week 6, n=205, 470
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase3.239.158Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase1.198.708Not reportedNot reportedNot reported
Week 8, n=190, 472
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase2.919.751Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase1.789.227Not reportedNot reportedNot reported
Week 12, n=174, 450
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase4.2810.188Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase2.029.539Not reportedNot reportedNot reported
Week 16, n=143, 403
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase5.879.975Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase2.3810.419Not reportedNot reportedNot reported
Week 20, n=132, 371
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase5.739.688Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase2.109.530Not reportedNot reportedNot reported
Week 24, n=99, 262
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase3.779.912Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase2.039.399Not reportedNot reportedNot reported
Week 28, n=74, 211
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase2.7210.038Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase1.6410.328Not reportedNot reportedNot reported
Week 32, n=67, 196
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase4.288.281Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase1.629.676Not reportedNot reportedNot reported
Week 36, n=62, 186
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase5.4210.109Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase2.1110.205Not reportedNot reportedNot reported
Week 40, n=59, 171
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase4.838.919Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase0.789.895Not reportedNot reportedNot reported
Week 44, n=59, 165
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase5.5311.005Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase1.168.846Not reportedNot reportedNot reported
End of Treatment, n=237, 467
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase4.0110.606Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase2.8911.134Not reportedNot reportedNot reported
4-week FU, n=220, 422
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase4.2710.432Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase2.1110.113Not reportedNot reportedNot reported
12-week FU, n=206, 429
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase1.739.707Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase0.749.955Not reportedNot reportedNot reported
24-week FU, n=202, 395
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0.149.803Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase-1.909.176Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.358
        value
        1.16
      2. group Id
        OG001
        spread
        8.629
        value
        -0.43
    title
    Week 1, n=244, 490
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.510
        value
        1.89
      2. group Id
        OG001
        spread
        9.644
        value
        0.78
    title
    Week 2, n=242, 490
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.464
        value
        2.47
      2. group Id
        OG001
        spread
        9.739
        value
        1.50
    title
    Week 4, n=227, 483
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.158
        value
        3.23
      2. group Id
        OG001
        spread
        8.708
        value
        1.19
    title
    Week 6, n=205, 470
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.751
        value
        2.91
      2. group Id
        OG001
        spread
        9.227
        value
        1.78
    title
    Week 8, n=190, 472
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.188
        value
        4.28
      2. group Id
        OG001
        spread
        9.539
        value
        2.02
    title
    Week 12, n=174, 450
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.975
        value
        5.87
      2. group Id
        OG001
        spread
        10.419
        value
        2.38
    title
    Week 16, n=143, 403
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.688
        value
        5.73
      2. group Id
        OG001
        spread
        9.530
        value
        2.10
    title
    Week 20, n=132, 371
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.912
        value
        3.77
      2. group Id
        OG001
        spread
        9.399
        value
        2.03
    title
    Week 24, n=99, 262
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.038
        value
        2.72
      2. group Id
        OG001
        spread
        10.328
        value
        1.64
    title
    Week 28, n=74, 211
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.281
        value
        4.28
      2. group Id
        OG001
        spread
        9.676
        value
        1.62
    title
    Week 32, n=67, 196
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.109
        value
        5.42
      2. group Id
        OG001
        spread
        10.205
        value
        2.11
    title
    Week 36, n=62, 186
denoms
  1. counts
    1. group Id
      OG000
      value
      244
    2. group Id
      OG001
      value
      490
    units
    Participants
description
Heart rate was measured in participants 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 Heart Rate at the Indicated Time Points During the DB Phase
type
SECONDARY
unit Of Measure
beats per minute

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice