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NCT00105443 · BASELINE

Baseline characteristics

A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma · Source last updated 2014-10-31

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
      299
    2. group Id
      BG001
      value
      303
    3. group Id
      BG002
      value
      602
    units
    Participants
groups
  1. description
    Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
    id
    BG000
    title
    Sorafenib (Nexavar, BAY43-9006)
  2. description
    Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.2
          value
          64.9
        2. group Id
          BG001
          spread
          10.2
          value
          66.3
        3. group Id
          BG002
          spread
          10.7
          value
          65.6
    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
          39
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          78
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          264
        3. group Id
          BG002
          value
          524
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          161
        2. group Id
          BG001
          value
          164
        3. group Id
          BG002
          value
          325
      title
      0 = fully active
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          231
      title
      1 = restricted in physical activity but ambulatory
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          46
      title
      2 = capable of selfcare
    description
    Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is a scale that measures how cancer affects a patient. The scale ranges from 0 (fully active) to 5 (dead). Subjects entering this study were to have an ECOG score of 0, 1 or 2.
    param Type
    NUMBER
    title
    Baseline Eastern Cooperative Oncology Group (ECOG)
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          90
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          181
      title
      Absent
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          209
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          421
      title
      Present
    description
    Tumor burden refers to the number of cancer cells, the size of a tumor, or the amount of cancer in the body and is also called the tumor load. Randomization was stratified by "tumor burden" assessment, ie, the presence of either macroscopic vascular invasion as determined by radiological assessment and/or extra-hepatic spread versus none.
    param Type
    NUMBER
    title
    Tumor burden
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      299
    2. group Id
      BG001
      value
      303
    3. group Id
      BG002
      value
      602
    units
    Participants
groups
  1. description
    Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
    id
    BG000
    title
    Sorafenib (Nexavar, BAY43-9006)
  2. description
    Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.2
          value
          64.9
        2. group Id
          BG001
          spread
          10.2
          value
          66.3
        3. group Id
          BG002
          spread
          10.7
          value
          65.6
    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
          39
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          78
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          264
        3. group Id
          BG002
          value
          524
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          161
        2. group Id
          BG001
          value
          164
        3. group Id
          BG002
          value
          325
      title
      0 = fully active
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          231
      title
      1 = restricted in physical activity but ambulatory
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          46
      title
      2 = capable of selfcare
    description
    Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is a scale that measures how cancer affects a patient. The scale ranges from 0 (fully active) to 5 (dead). Subjects entering this study were to have an ECOG score of 0, 1 or 2.
    param Type
    NUMBER
    title
    Baseline Eastern Cooperative Oncology Group (ECOG)
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          90
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          181
      title
      Absent
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          209
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          421
      title
      Present
    description
    Tumor burden refers to the number of cancer cells, the size of a tumor, or the amount of cancer in the body and is also called the tumor load. Randomization was stratified by "tumor burden" assessment, ie, the presence of either macroscopic vascular invasion as determined by radiological assessment and/or extra-hepatic spread versus none.
    param Type
    NUMBER
    title
    Tumor burden
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice