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NCT00516321 · OUTCOME

Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) 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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)

What was measured

Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The investigator assigned an ECG status of normal, abnormal, CS, or NCS; a status of "abnormal" alone indicates that the investigator did not determine if ECG was CS or NCS. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.

Analysis population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. Worst ECG post-BL is the worst ECG assessment reported for a participant at a post-BL assessment and could be Normal, Abnormal - NCS, Abnormal - CS, or Abnormal (NCS or CS not given).

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 Phase229
Eltrombopag+Antiviral Therapy: DB Phase447

Reported measurements

Antiviral BL, Normal, n=219, 423
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase149Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase278Not reportedNot reportedNot reportedNot reported
Antiviral BL, Abnormal - NCS, n=219, 423
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase53Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase108Not reportedNot reportedNot reportedNot reported
Antiviral BL, Abnormal - CS, n=219, 423
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase17Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase37Not reportedNot reportedNot reportedNot reported
End of Treatment, Normal, n=198, 384
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase139Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase251Not reportedNot reportedNot reportedNot reported
End of Treatment, Abnormal - NCS, n=198, 384
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase50Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase108Not reportedNot reportedNot reportedNot reported
End of Treatment, Abnormal - CS, n=198, 384
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase9Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase24Not reportedNot reportedNot reportedNot reported
End of Treatment, Abnormal, n=198, 384
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase1Not reportedNot reportedNot reportedNot reported
24-week FU, Normal, n=186, 368
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase120Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase235Not reportedNot reportedNot reportedNot reported
24-week FU, Abnormal - NCS, n=186, 368
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase53Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase106Not reportedNot reportedNot reportedNot reported
24-week FU, Abnormal - CS, n=186, 368
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase13Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase27Not reportedNot reportedNot reportedNot reported
Worst ECG post-BL, Normal, n=229, 447
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase105Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase188Not reportedNot reportedNot reportedNot reported
Worst ECG post-BL, Abnormal - NCS, n=229, 447
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase87Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase186Not reportedNot reportedNot reportedNot reported
Worst ECG post-BL, Abnormal - CS, n=229, 447
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase37Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase72Not reportedNot reportedNot reportedNot reported
Worst ECG post-BL, Abnormal, n=229, 447
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase0Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        149
      2. group Id
        OG001
        value
        278
    title
    Antiviral BL, Normal, n=219, 423
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        53
      2. group Id
        OG001
        value
        108
    title
    Antiviral BL, Abnormal - NCS, n=219, 423
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        37
    title
    Antiviral BL, Abnormal - CS, n=219, 423
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        139
      2. group Id
        OG001
        value
        251
    title
    End of Treatment, Normal, n=198, 384
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        108
    title
    End of Treatment, Abnormal - NCS, n=198, 384
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        24
    title
    End of Treatment, Abnormal - CS, n=198, 384
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    End of Treatment, Abnormal, n=198, 384
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        120
      2. group Id
        OG001
        value
        235
    title
    24-week FU, Normal, n=186, 368
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        53
      2. group Id
        OG001
        value
        106
    title
    24-week FU, Abnormal - NCS, n=186, 368
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        27
    title
    24-week FU, Abnormal - CS, n=186, 368
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        105
      2. group Id
        OG001
        value
        188
    title
    Worst ECG post-BL, Normal, n=229, 447
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        87
      2. group Id
        OG001
        value
        186
    title
    Worst ECG post-BL, Abnormal - NCS, n=229, 447
denoms
  1. counts
    1. group Id
      OG000
      value
      229
    2. group Id
      OG001
      value
      447
    units
    Participants
description
Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The investigator assigned an ECG status of normal, abnormal, CS, or NCS; a status of "abnormal" alone indicates that the investigator did not determine if ECG was CS or NCS. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.
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
NUMBER
population Description
Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. Worst ECG post-BL is the worst ECG assessment reported for a participant at a post-BL assessment and could be Normal, Abnormal - NCS, Abnormal - CS, or Abnormal (NCS or CS not given).
reporting Status
POSTED
time Frame
DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
title
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice