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NCT01140347 · BASELINE

Baseline characteristics

A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib · Source last updated 2015-12-28

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
      283
    2. group Id
      BG001
      value
      282
    3. group Id
      BG002
      value
      565
    units
    Participants
groups
  1. description
    Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
    id
    BG000
    title
    Ramucirumab (IMC-1121B) + BSC
  2. description
    Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
    id
    BG001
    title
    Placebo + BSC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.56
          value
          62.9
        2. group Id
          BG001
          spread
          11.10
          value
          62.5
        3. group Id
          BG002
          spread
          11.33
          value
          62.7
    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
          150
        2. group Id
          BG001
          value
          162
        3. group Id
          BG002
          value
          312
      title
      <65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          133
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          253
      title
      ≥65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          87
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          236
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          478
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          43
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          253
        2. group Id
          BG001
          value
          260
        3. group Id
          BG002
          value
          513
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. 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
          131
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          266
        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
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          137
        3. group Id
          BG002
          value
          276
        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
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          37
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Portugal
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Philippines
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          58
      title
      Taiwan
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          24
      title
      Hong Kong
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          21
      title
      Spain
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
      title
      Thailand
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Israel
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Switzerland
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          51
      title
      Italy
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          59
      title
      France
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
      title
      Australia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
All randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      283
    2. group Id
      BG001
      value
      282
    3. group Id
      BG002
      value
      565
    units
    Participants
groups
  1. description
    Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
    id
    BG000
    title
    Ramucirumab (IMC-1121B) + BSC
  2. description
    Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
    id
    BG001
    title
    Placebo + BSC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.56
          value
          62.9
        2. group Id
          BG001
          spread
          11.10
          value
          62.5
        3. group Id
          BG002
          spread
          11.33
          value
          62.7
    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
          150
        2. group Id
          BG001
          value
          162
        3. group Id
          BG002
          value
          312
      title
      <65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          133
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          253
      title
      ≥65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          87
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          236
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          478
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          43
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          253
        2. group Id
          BG001
          value
          260
        3. group Id
          BG002
          value
          513
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. 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
          131
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          266
        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
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          137
        3. group Id
          BG002
          value
          276
        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
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          37
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Portugal
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Philippines
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          58
      title
      Taiwan
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          24
      title
      Hong Kong
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          21
      title
      Spain
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
      title
      Thailand
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Israel
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Switzerland
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          51
      title
      Italy
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          59
      title
      France
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
      title
      Australia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
All randomized participants.

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Preserved source evidence · Not medical advice