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NCT00516321 · 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 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
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-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 Phase443

Reported measurements

Week 1, n=231, 440
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0.68.99Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase0.98.50Not reportedNot reportedNot reported
Week 2, n=227, 435
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase1.19.31Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase2.39.16Not reportedNot reportedNot reported
Week 4, n=217, 428
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase1.79.83Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase2.79.01Not reportedNot reportedNot reported
Week 6, n=195, 419
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase2.311.74Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase2.98.88Not reportedNot reportedNot reported
Week 8, n=190, 414
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase2.310.27Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase3.69.98Not reportedNot reportedNot reported
Week 12, n=164, 404
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase3.811.30Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase4.19.93Not reportedNot reportedNot reported
Week 16, n=140, 375
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase4.711.81Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase4.29.87Not reportedNot reportedNot reported
Week 20, n=135, 363
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase3.411.05Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase4.89.73Not reportedNot reportedNot reported
Week 24, n=88, 248
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase4.811.34Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase4.710.91Not reportedNot reportedNot reported
Week 28, n=73, 200
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase4.610.29Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase4.59.75Not reportedNot reportedNot reported
Week 32, n=68, 182
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase6.110.48Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase5.510.46Not reportedNot reportedNot reported
Week 36, n=68, 174
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase5.511.55Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase4.111.84Not reportedNot reportedNot reported
Week 40, n=64, 166
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase5.89.33Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase5.010.32Not reportedNot reportedNot reported
Week 44, n=64, 166
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase5.311.30Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase5.59.94Not reportedNot reportedNot reported
End of Treatment, n=212, 419
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase2.910.54Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase4.310.84Not reportedNot reportedNot reported
4-week FU, n=204, 397
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase2.711.47Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase3.510.38Not reportedNot reportedNot reported
12-week FU, n=197, 400
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0.511.23Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase1.710.40Not reportedNot reportedNot reported
24-week FU, n=197, 393
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0.111.61Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase0.510.34Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.99
        value
        0.6
      2. group Id
        OG001
        spread
        8.50
        value
        0.9
    title
    Week 1, n=231, 440
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.31
        value
        1.1
      2. group Id
        OG001
        spread
        9.16
        value
        2.3
    title
    Week 2, n=227, 435
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.83
        value
        1.7
      2. group Id
        OG001
        spread
        9.01
        value
        2.7
    title
    Week 4, n=217, 428
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.74
        value
        2.3
      2. group Id
        OG001
        spread
        8.88
        value
        2.9
    title
    Week 6, n=195, 419
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.27
        value
        2.3
      2. group Id
        OG001
        spread
        9.98
        value
        3.6
    title
    Week 8, n=190, 414
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.30
        value
        3.8
      2. group Id
        OG001
        spread
        9.93
        value
        4.1
    title
    Week 12, n=164, 404
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.81
        value
        4.7
      2. group Id
        OG001
        spread
        9.87
        value
        4.2
    title
    Week 16, n=140, 375
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.05
        value
        3.4
      2. group Id
        OG001
        spread
        9.73
        value
        4.8
    title
    Week 20, n=135, 363
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.34
        value
        4.8
      2. group Id
        OG001
        spread
        10.91
        value
        4.7
    title
    Week 24, n=88, 248
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.29
        value
        4.6
      2. group Id
        OG001
        spread
        9.75
        value
        4.5
    title
    Week 28, n=73, 200
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.48
        value
        6.1
      2. group Id
        OG001
        spread
        10.46
        value
        5.5
    title
    Week 32, n=68, 182
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.55
        value
        5.5
      2. group Id
        OG001
        spread
        11.84
        value
        4.1
    title
    Week 36, n=68, 174
denoms
  1. counts
    1. group Id
      OG000
      value
      231
    2. group Id
      OG001
      value
      443
    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-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 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