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NCT00516321 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      232
    2. group Id
      BG001
      value
      450
    3. group Id
      BG002
      value
      682
    units
    Participants
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
    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 \>=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
    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
          8.52
          value
          51.4
        2. group Id
          BG001
          spread
          8.35
          value
          52.1
        3. group Id
          BG002
          spread
          8.41
          value
          51.9
      title
      Years
    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
          73
        2. group Id
          BG001
          value
          186
        3. group Id
          BG002
          value
          259
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          159
        2. group Id
          BG001
          value
          264
        3. group Id
          BG002
          value
          423
        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
          6
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          18
      title
      African American/African Heritage
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      American Indian/Alaska Native
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          53
      title
      Central/South Asian Heritage
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          111
      title
      Japanese/East Asian Heritage/South East Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          166
        2. group Id
          BG001
          value
          326
        3. group Id
          BG002
          value
          492
      title
      White
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Asian and White
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian/ Other Pacific Islander and White
    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
          149
        2. group Id
          BG001
          value
          292
        3. group Id
          BG002
          value
          441
      title
      Genotype 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          49
      title
      Genotype 2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          169
      title
      Genotype 3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          16
      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
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
      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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Missing Data
    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
          217
        2. group Id
          BG001
          value
          424
        3. group Id
          BG002
          value
          641
      title
      Class A
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          40
      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
          1
        3. group Id
          BG002
          value
          1
      title
      Missing Data
    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); \>=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
          152
        2. group Id
          BG001
          value
          307
        3. group Id
          BG002
          value
          459
      title
      Naïve
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          223
      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
          23
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          60
      title
      Score: F0/F1/F2
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          185
        2. group Id
          BG001
          value
          354
        3. group Id
          BG002
          value
          539
      title
      Score: F3/F4
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          83
      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
          54
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          157
      title
      Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          178
        2. group Id
          BG001
          value
          347
        3. group Id
          BG002
          value
          525
      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
          3395777.02
          value
          1880278.4
        2. group Id
          BG001
          spread
          3080918.03
          value
          1870562.1
        3. group Id
          BG002
          spread
          3188864.74
          value
          1873862.8
    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 one participant 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
          12.890
          value
          57.40
        2. group Id
          BG001
          spread
          13.603
          value
          56.87
        3. group Id
          BG002
          spread
          13.357
          value
          57.05
    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
      232
    2. group Id
      BG001
      value
      450
    3. group Id
      BG002
      value
      682
    units
    Participants
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
    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 \>=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
    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
          8.52
          value
          51.4
        2. group Id
          BG001
          spread
          8.35
          value
          52.1
        3. group Id
          BG002
          spread
          8.41
          value
          51.9
      title
      Years
    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
          73
        2. group Id
          BG001
          value
          186
        3. group Id
          BG002
          value
          259
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          159
        2. group Id
          BG001
          value
          264
        3. group Id
          BG002
          value
          423
        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
          6
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          18
      title
      African American/African Heritage
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      American Indian/Alaska Native
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          53
      title
      Central/South Asian Heritage
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          111
      title
      Japanese/East Asian Heritage/South East Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          166
        2. group Id
          BG001
          value
          326
        3. group Id
          BG002
          value
          492
      title
      White
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Asian and White
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian/ Other Pacific Islander and White
    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
          149
        2. group Id
          BG001
          value
          292
        3. group Id
          BG002
          value
          441
      title
      Genotype 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          49
      title
      Genotype 2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          169
      title
      Genotype 3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          16
      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
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
      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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Missing Data
    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
          217
        2. group Id
          BG001
          value
          424
        3. group Id
          BG002
          value
          641
      title
      Class A
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          40
      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
          1
        3. group Id
          BG002
          value
          1
      title
      Missing Data
    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); \>=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
          152
        2. group Id
          BG001
          value
          307
        3. group Id
          BG002
          value
          459
      title
      Naïve
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          223
      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
          23
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          60
      title
      Score: F0/F1/F2
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          185
        2. group Id
          BG001
          value
          354
        3. group Id
          BG002
          value
          539
      title
      Score: F3/F4
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          83
      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
          54
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          157
      title
      Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          178
        2. group Id
          BG001
          value
          347
        3. group Id
          BG002
          value
          525
      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
          3395777.02
          value
          1880278.4
        2. group Id
          BG001
          spread
          3080918.03
          value
          1870562.1
        3. group Id
          BG002
          spread
          3188864.74
          value
          1873862.8
    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 one participant 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
          12.890
          value
          57.40
        2. group Id
          BG001
          spread
          13.603
          value
          56.87
        3. group Id
          BG002
          spread
          13.357
          value
          57.05
    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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