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NCT00529568 · OUTCOME

Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
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

Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Analysis population: Safety DB Population

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 Phase252
Eltrombopag+Antiviral Therapy: DB Phase506

Reported measurements

Hemoglobin (anemia), Any Grade Increase
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase161Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase361Not reportedNot reportedNot reportedNot reported
Hemoglobin (anemia), Increase to G1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase46Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase112Not reportedNot reportedNot reportedNot reported
Hemoglobin (anemia), Increase to G2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase64Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase129Not reportedNot reportedNot reportedNot reported
Hemoglobin (anemia), Increase to G3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase48Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase114Not reportedNot reportedNot reportedNot reported
Hemoglobin (anemia), Increase to G4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase3Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase6Not reportedNot reportedNot reportedNot reported
Lym. (lymphocytopenia), Any Grade Increase
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase136Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase346Not reportedNot reportedNot reportedNot reported
Lym. (lymphocytopenia), Increase to G1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase16Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase43Not reportedNot reportedNot reportedNot reported
Lym. (lymphocytopenia), Increase to G2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase38Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase80Not reportedNot reportedNot reportedNot reported
Lym. (lymphocytopenia), Increase to G3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase48Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase109Not reportedNot reportedNot reportedNot reported
Lym. (lymphocytopenia), Increase to G4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase34Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase114Not reportedNot reportedNot reportedNot reported
Tot Neu. (neutropenia), Any Grade Increase
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase208Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase394Not reportedNot reportedNot reportedNot reported
Tot Neu. (neutropenia), Increase to G1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase50Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase106Not reportedNot reportedNot reportedNot reported
Tot Neu. (neutropenia), Increase to G2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase53Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase113Not reportedNot reportedNot reportedNot reported
Tot Neu. (neutropenia), Increase to G3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase73Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase128Not reportedNot reportedNot reportedNot reported
Tot Neu. (neutropenia), Increase to G4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase32Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase47Not reportedNot reportedNot reportedNot reported
WBC (leukocytopenia), Any Grade Increase
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase191Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase391Not reportedNot reportedNot reportedNot reported
WBC (leukocytopenia), Increase to G1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase56Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase113Not reportedNot reportedNot reportedNot reported
WBC (leukocytopenia), Increase to G2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase69Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase145Not reportedNot reportedNot reportedNot reported
WBC (leukocytopenia), Increase to G3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase58Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase110Not reportedNot reportedNot reportedNot reported
WBC (leukocytopenia), Increase to G4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo+Antiviral Therapy: DB Phase8Not reportedNot reportedNot reportedNot reported
Eltrombopag+Antiviral Therapy: DB Phase23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        161
      2. group Id
        OG001
        value
        361
    title
    Hemoglobin (anemia), Any Grade Increase
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        112
    title
    Hemoglobin (anemia), Increase to G1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        129
    title
    Hemoglobin (anemia), Increase to G2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        114
    title
    Hemoglobin (anemia), Increase to G3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
    title
    Hemoglobin (anemia), Increase to G4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        136
      2. group Id
        OG001
        value
        346
    title
    Lym. (lymphocytopenia), Any Grade Increase
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        43
    title
    Lym. (lymphocytopenia), Increase to G1
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        80
    title
    Lym. (lymphocytopenia), Increase to G2
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        109
    title
    Lym. (lymphocytopenia), Increase to G3
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        114
    title
    Lym. (lymphocytopenia), Increase to G4
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        208
      2. group Id
        OG001
        value
        394
    title
    Tot Neu. (neutropenia), Any Grade Increase
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        106
    title
    Tot Neu. (neutropenia), Increase to G1
denoms
  1. counts
    1. group Id
      OG000
      value
      252
    2. group Id
      OG001
      value
      506
    units
    Participants
description
Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
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
NUMBER
population Description
Safety DB Population
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
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice