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NCT00516321 · OUTCOME

Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in 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
weeks
Interval / dispersion
Standard Deviation
Time frame
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

What was measured

Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.

Analysis population: ITT Population. Only those participants with dose reductions 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 Phase163
Eltrombopag+Antiviral Therapy: DB Phase193

Reported measurements

Peginterferon alfa-2a dose reduction, n=163, 193
Values in weeks · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase5.815.304Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase9.049.371Not reportedNot reportedNot reported
Ribavirin dose reduction, n=63, 162
Values in weeks · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase11.169.219Not reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase12.589.830Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.304
        value
        5.81
      2. group Id
        OG001
        spread
        9.371
        value
        9.04
    title
    Peginterferon alfa-2a dose reduction, n=163, 193
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.219
        value
        11.16
      2. group Id
        OG001
        spread
        9.830
        value
        12.58
    title
    Ribavirin dose reduction, n=63, 162
denoms
  1. counts
    1. group Id
      OG000
      value
      163
    2. group Id
      OG001
      value
      193
    units
    Participants
description
Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.
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
ITT Population. Only those participants with dose reductions were analyzed.
reporting Status
POSTED
time Frame
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
title
Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice