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NCT03434379 · BASELINE

Baseline characteristics

A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma · Source last updated 2023-10-23

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
      183
    2. group Id
      BG001
      value
      375
    3. group Id
      BG002
      value
      558
    units
    Participants
groups
  1. description
    All participants either in the Global or China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    BG000
    title
    Sorafenib - All
  2. description
    All participants either in the Global or China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    BG001
    title
    Atezolizumab + Bevacizumab - All
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.9
          value
          64.4
        2. group Id
          BG001
          spread
          11.9
          value
          62.9
        3. group Id
          BG002
          spread
          11.6
          value
          63.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          336
        3. group Id
          BG002
          value
          501
        units
        Participants
      title
      Global
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.7
          value
          57.5
        2. group Id
          BG001
          spread
          12.0
          value
          55.3
        3. group Id
          BG002
          spread
          12.3
          value
          56.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          194
        units
        Participants
      title
      China
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          87
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          137
        2. group Id
          BG001
          value
          277
        3. group Id
          BG002
          value
          414
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          336
        3. group Id
          BG002
          value
          501
        units
        Participants
      title
      Global
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          165
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          194
        units
        Participants
      title
      China
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
    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
          9
        3. group Id
          BG002
          value
          13
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          149
        2. group Id
          BG001
          value
          306
        3. group Id
          BG002
          value
          455
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          33
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          336
        3. group Id
          BG002
          value
          501
        units
        Participants
      title
      Global
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          194
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          194
        units
        Participants
      title
      China
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          96
        2. group Id
          BG001
          value
          188
        3. group Id
          BG002
          value
          284
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          175
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          31
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          336
        3. group Id
          BG002
          value
          501
        units
        Participants
      title
      Global
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          194
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          194
        units
        Participants
      title
      China
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The intent-to-treat (ITT) population included 558 participants (All) with 501 in the Global population. An additional 57 participants enrolled in the China Extension. The China population included 137 Chinese participants from the Global population plus 57 participants from the China Extension. The Global population and China population were analyzed separately.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      183
    2. group Id
      BG001
      value
      375
    3. group Id
      BG002
      value
      558
    units
    Participants
groups
  1. description
    All participants either in the Global or China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    BG000
    title
    Sorafenib - All
  2. description
    All participants either in the Global or China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    BG001
    title
    Atezolizumab + Bevacizumab - All
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.9
          value
          64.4
        2. group Id
          BG001
          spread
          11.9
          value
          62.9
        3. group Id
          BG002
          spread
          11.6
          value
          63.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          336
        3. group Id
          BG002
          value
          501
        units
        Participants
      title
      Global
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.7
          value
          57.5
        2. group Id
          BG001
          spread
          12.0
          value
          55.3
        3. group Id
          BG002
          spread
          12.3
          value
          56.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          194
        units
        Participants
      title
      China
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          87
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          137
        2. group Id
          BG001
          value
          277
        3. group Id
          BG002
          value
          414
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          336
        3. group Id
          BG002
          value
          501
        units
        Participants
      title
      Global
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          165
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          194
        units
        Participants
      title
      China
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
    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
          9
        3. group Id
          BG002
          value
          13
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          149
        2. group Id
          BG001
          value
          306
        3. group Id
          BG002
          value
          455
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          33
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          336
        3. group Id
          BG002
          value
          501
        units
        Participants
      title
      Global
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          194
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          194
        units
        Participants
      title
      China
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          96
        2. group Id
          BG001
          value
          188
        3. group Id
          BG002
          value
          284
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          175
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          31
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          336
        3. group Id
          BG002
          value
          501
        units
        Participants
      title
      Global
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          194
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          194
        units
        Participants
      title
      China
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The intent-to-treat (ITT) population included 558 participants (All) with 501 in the Global population. An additional 57 participants enrolled in the China Extension. The China population included 137 Chinese participants from the Global population plus 57 participants from the China Extension. The Global population and China population were analyzed separately.

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