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NCT02435433 · BASELINE

Baseline characteristics

A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein · Source last updated 2023-01-20

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
      197
    2. group Id
      BG001
      value
      95
    3. group Id
      BG002
      value
      47
    4. group Id
      BG003
      value
      39
    5. group Id
      BG004
      value
      21
    6. group Id
      BG005
      value
      399
    units
    Participants
groups
  1. description
    8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
    id
    BG000
    title
    Ramucirumab + BSC
  2. description
    Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
    id
    BG001
    title
    Placebo + Best Supportive Care (BSC)
  3. description
    8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
    id
    BG002
    title
    Open Label Ramucirumab + BSC
  4. description
    8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
    id
    BG003
    title
    Ramucirumab MEE Cohort
  5. description
    Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
    id
    BG004
    title
    Placebo MEE Cohort
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          30
          upper Limit
          88
          value
          64
        2. group Id
          BG001
          lower Limit
          26
          upper Limit
          85
          value
          64
        3. group Id
          BG002
          lower Limit
          36
          upper Limit
          82
          value
          61
        4. group Id
          BG003
          lower Limit
          24
          upper Limit
          74
          value
          54
        5. group Id
          BG004
          lower Limit
          31
          upper Limit
          66
          value
          54
        6. group Id
          BG005
          lower Limit
          24
          upper Limit
          88
          value
          62
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          73
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          154
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          326
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          22
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          248
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          27
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          129
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          102
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          39
        5. group Id
          BG004
          value
          21
        6. group Id
          BG005
          value
          233
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          104
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          51
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          15
      title
      Hong Kong
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          23
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          6
      title
      Czechia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          59
      title
      Japan
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          11
      title
      United Kingdom
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
      title
      Switzerland
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
      title
      Spain
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
      title
      Canada
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
      title
      Austria
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          38
      title
      South Korea
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
      title
      Belgium
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          39
        5. group Id
          BG004
          value
          21
        6. group Id
          BG005
          value
          72
      title
      China
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All participants who received at least one dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      197
    2. group Id
      BG001
      value
      95
    3. group Id
      BG002
      value
      47
    4. group Id
      BG003
      value
      39
    5. group Id
      BG004
      value
      21
    6. group Id
      BG005
      value
      399
    units
    Participants
groups
  1. description
    8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
    id
    BG000
    title
    Ramucirumab + BSC
  2. description
    Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
    id
    BG001
    title
    Placebo + Best Supportive Care (BSC)
  3. description
    8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
    id
    BG002
    title
    Open Label Ramucirumab + BSC
  4. description
    8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
    id
    BG003
    title
    Ramucirumab MEE Cohort
  5. description
    Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
    id
    BG004
    title
    Placebo MEE Cohort
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          30
          upper Limit
          88
          value
          64
        2. group Id
          BG001
          lower Limit
          26
          upper Limit
          85
          value
          64
        3. group Id
          BG002
          lower Limit
          36
          upper Limit
          82
          value
          61
        4. group Id
          BG003
          lower Limit
          24
          upper Limit
          74
          value
          54
        5. group Id
          BG004
          lower Limit
          31
          upper Limit
          66
          value
          54
        6. group Id
          BG005
          lower Limit
          24
          upper Limit
          88
          value
          62
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          73
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          154
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          326
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          22
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          248
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          27
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          129
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          102
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          39
        5. group Id
          BG004
          value
          21
        6. group Id
          BG005
          value
          233
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          104
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          51
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          15
      title
      Hong Kong
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          23
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          6
      title
      Czechia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          59
      title
      Japan
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          11
      title
      United Kingdom
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
      title
      Switzerland
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
      title
      Spain
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
      title
      Canada
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
      title
      Austria
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          38
      title
      South Korea
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
      title
      Belgium
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          39
        5. group Id
          BG004
          value
          21
        6. group Id
          BG005
          value
          72
      title
      China
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All participants who received at least one dose of study drug.

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Preserved source evidence · Not medical advice