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NCT00529568 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      253
    2. group Id
      BG001
      value
      506
    3. group Id
      BG002
      value
      759
    units
    Participants
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
    BG000
    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
    BG001
    title
    Eltrombopag+Antiviral Therapy: DB Phase
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.15
          value
          52.0
        2. group Id
          BG001
          spread
          8.61
          value
          52.4
        3. group Id
          BG002
          spread
          8.79
          value
          52.3
    description
    Baseline characteristics were collected for the Intent-to-Treat (ITT) Population, which included all randomized participants in the Double-blind (DB) Phase of the study.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          185
        3. group Id
          BG002
          value
          278
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          160
        2. group Id
          BG001
          value
          321
        3. group Id
          BG002
          value
          481
        title
        Male
    description
    Baseline characteristics were collected for the Intent-to-Treat (ITT) Population, which included all randomized participants in the Double-blind (DB) Phase of the study.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          12
      title
      African American (A)/African
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      American Indian or Alaska Native
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          188
        2. group Id
          BG001
          value
          388
        3. group Id
          BG002
          value
          576
      title
      White (W)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          59
      title
      Central/South Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          109
      title
      Japanese/East Asian /South East Asian
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      American Indian or Alaska Native and White
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      African A/African and A Indian/Alaska Native and W
    description
    Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study.
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          160
        2. group Id
          BG001
          value
          320
        3. group Id
          BG002
          value
          480
      title
      Genotype 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          68
      title
      Genotype 2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          160
      title
      Genotype 3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          47
      title
      Genotype 4
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Genotype 5
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Genotype 6
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Genotype 7
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Missing
    description
    Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. The HCV is a small, enveloped, single-stranded, positive-sense ribonucleic acid (RNA) virus. There are seven major genotypes of HCV, which are indicated numerically from Genotype 1 to 7.
    param Type
    NUMBER
    title
    Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV)
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          242
        2. group Id
          BG001
          value
          487
        3. group Id
          BG002
          value
          729
      title
      Class A
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          28
      title
      Class B
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Class C
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Missing
    description
    The CP score (ranging from 5 to 15, with 5 being mild and 15 being severe), calculated based on total bilirubin, serum albumin, international normalized ratio, ascites, and hepatic encephalopathy, is used to assess the severity of liver disease. A CP score of 5-6 = Class A (mild), 7-9 = Class B (moderate), and \>=10 = Class C (severe).
    param Type
    NUMBER
    title
    Number of participants categorized into the indicated Child-Pugh (CP) Class
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          182
        2. group Id
          BG001
          value
          347
        3. group Id
          BG002
          value
          529
      title
      Naïve
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          230
      title
      Experienced
    description
    Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. Participants at Baseline were classified as not having used IFN previously (Naïve) or having used IFN previously (Experienced).
    param Type
    NUMBER
    title
    Number of participants with or without previous interferon (IFN) use
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          65
      title
      Score: F0/F1/F2
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          405
        3. group Id
          BG002
          value
          604
      title
      Score: F3/F4
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          90
      title
      Missing
    description
    FibroSURE is a noninvasive blood test that combines the quantitative results of 6 serum biochemical markers (α2-macroglobulin, haptoglobin, apolipoprotein A1, bilirubin, γ-glutamyl transpeptidase \[GGT\], and ALT) with a participant's age and gender to generate a measure of liver fibrosis/cirrhosis and necroinflammatory activity. It provides a numerical quantitative estimate of liver fibrosis ranging from 0.00 to 1.00, corresponding to the Metavir scoring system of stages F0 to F4 (F0, no fibrosis \[F\]; F1, portal F; F2, bridging F with few septa; F3, bridging F with many septa; F4=cirrhosis).
    param Type
    NUMBER
    title
    Number of participants with the indicated FibroTest/Acti Test (FibroSURE) score
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          162
      title
      Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          204
        2. group Id
          BG001
          value
          393
        3. group Id
          BG002
          value
          597
      title
      Elevated
    description
    Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. The normal range of ALT is 0 to 48 International Units per Liter (IU/L).
    param Type
    NUMBER
    title
    Number of participants with normal or elevated Baseline values for Alanine Aminotransferase (ALT)
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2564763.45
          value
          1656788.0
        2. group Id
          BG001
          spread
          3066411.11
          value
          1702729.6
        3. group Id
          BG002
          spread
          2907191.97
          value
          1687415.8
    description
    Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. HCV RNA was assessed at baseline of the DB Phase. Data are missing for three participants in the Eltrombopag+Antiviral Therapy treatment group.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline HCV Ribonucleic Acid (RNA)
    unit Of Measure
    International Units per milliliter
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.571
          value
          56.56
        2. group Id
          BG001
          spread
          13.311
          value
          56.85
        3. group Id
          BG002
          spread
          13.390
          value
          56.75
    description
    Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. Platelet count eligibility was confirmed at the Baseline visit, prior to administration of eltrombopag, and was defined as the average of the screening and baseline counts, which must be \<75 Gi/L.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Platelet Count
    unit Of Measure
    Giga (10^9) cells per liter (Gi/L)
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      253
    2. group Id
      BG001
      value
      506
    3. group Id
      BG002
      value
      759
    units
    Participants
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
    BG000
    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
    BG001
    title
    Eltrombopag+Antiviral Therapy: DB Phase
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.15
          value
          52.0
        2. group Id
          BG001
          spread
          8.61
          value
          52.4
        3. group Id
          BG002
          spread
          8.79
          value
          52.3
    description
    Baseline characteristics were collected for the Intent-to-Treat (ITT) Population, which included all randomized participants in the Double-blind (DB) Phase of the study.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          185
        3. group Id
          BG002
          value
          278
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          160
        2. group Id
          BG001
          value
          321
        3. group Id
          BG002
          value
          481
        title
        Male
    description
    Baseline characteristics were collected for the Intent-to-Treat (ITT) Population, which included all randomized participants in the Double-blind (DB) Phase of the study.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          12
      title
      African American (A)/African
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      American Indian or Alaska Native
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          188
        2. group Id
          BG001
          value
          388
        3. group Id
          BG002
          value
          576
      title
      White (W)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          59
      title
      Central/South Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          109
      title
      Japanese/East Asian /South East Asian
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      American Indian or Alaska Native and White
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      African A/African and A Indian/Alaska Native and W
    description
    Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study.
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          160
        2. group Id
          BG001
          value
          320
        3. group Id
          BG002
          value
          480
      title
      Genotype 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          68
      title
      Genotype 2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          160
      title
      Genotype 3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          47
      title
      Genotype 4
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Genotype 5
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Genotype 6
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Genotype 7
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Missing
    description
    Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. The HCV is a small, enveloped, single-stranded, positive-sense ribonucleic acid (RNA) virus. There are seven major genotypes of HCV, which are indicated numerically from Genotype 1 to 7.
    param Type
    NUMBER
    title
    Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV)
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          242
        2. group Id
          BG001
          value
          487
        3. group Id
          BG002
          value
          729
      title
      Class A
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          28
      title
      Class B
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Class C
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Missing
    description
    The CP score (ranging from 5 to 15, with 5 being mild and 15 being severe), calculated based on total bilirubin, serum albumin, international normalized ratio, ascites, and hepatic encephalopathy, is used to assess the severity of liver disease. A CP score of 5-6 = Class A (mild), 7-9 = Class B (moderate), and \>=10 = Class C (severe).
    param Type
    NUMBER
    title
    Number of participants categorized into the indicated Child-Pugh (CP) Class
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          182
        2. group Id
          BG001
          value
          347
        3. group Id
          BG002
          value
          529
      title
      Naïve
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          230
      title
      Experienced
    description
    Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. Participants at Baseline were classified as not having used IFN previously (Naïve) or having used IFN previously (Experienced).
    param Type
    NUMBER
    title
    Number of participants with or without previous interferon (IFN) use
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          65
      title
      Score: F0/F1/F2
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          405
        3. group Id
          BG002
          value
          604
      title
      Score: F3/F4
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          90
      title
      Missing
    description
    FibroSURE is a noninvasive blood test that combines the quantitative results of 6 serum biochemical markers (α2-macroglobulin, haptoglobin, apolipoprotein A1, bilirubin, γ-glutamyl transpeptidase \[GGT\], and ALT) with a participant's age and gender to generate a measure of liver fibrosis/cirrhosis and necroinflammatory activity. It provides a numerical quantitative estimate of liver fibrosis ranging from 0.00 to 1.00, corresponding to the Metavir scoring system of stages F0 to F4 (F0, no fibrosis \[F\]; F1, portal F; F2, bridging F with few septa; F3, bridging F with many septa; F4=cirrhosis).
    param Type
    NUMBER
    title
    Number of participants with the indicated FibroTest/Acti Test (FibroSURE) score
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          162
      title
      Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          204
        2. group Id
          BG001
          value
          393
        3. group Id
          BG002
          value
          597
      title
      Elevated
    description
    Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. The normal range of ALT is 0 to 48 International Units per Liter (IU/L).
    param Type
    NUMBER
    title
    Number of participants with normal or elevated Baseline values for Alanine Aminotransferase (ALT)
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2564763.45
          value
          1656788.0
        2. group Id
          BG001
          spread
          3066411.11
          value
          1702729.6
        3. group Id
          BG002
          spread
          2907191.97
          value
          1687415.8
    description
    Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. HCV RNA was assessed at baseline of the DB Phase. Data are missing for three participants in the Eltrombopag+Antiviral Therapy treatment group.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline HCV Ribonucleic Acid (RNA)
    unit Of Measure
    International Units per milliliter
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.571
          value
          56.56
        2. group Id
          BG001
          spread
          13.311
          value
          56.85
        3. group Id
          BG002
          spread
          13.390
          value
          56.75
    description
    Baseline characteristics were collected for the ITT Population, which included all randomized participants in the DB Phase of the study. Platelet count eligibility was confirmed at the Baseline visit, prior to administration of eltrombopag, and was defined as the average of the screening and baseline counts, which must be \<75 Gi/L.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Platelet Count
    unit Of Measure
    Giga (10^9) cells per liter (Gi/L)

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