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NCT00917384 · BASELINE

Baseline characteristics

Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma · Source last updated 2019-09-25

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
      238
    2. group Id
      BG001
      value
      117
    3. group Id
      BG002
      value
      355
    units
    Participants
groups
  1. description
    Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    id
    BG000
    title
    IMC-1121B (Ramucirumab)
  2. description
    Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    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
          lower Limit
          30
          upper Limit
          86
          value
          60.0
        2. group Id
          BG001
          lower Limit
          24
          upper Limit
          87
          value
          60.0
        3. group Id
          BG002
          lower Limit
          24
          upper Limit
          87
          value
          60.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          107
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          169
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          248
        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
          41
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          60
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          197
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          295
        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
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      title
      Argentina
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
      title
      Australia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Bosnia and Herzegovina
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          38
      title
      Brazil
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
      title
      Canada
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Chile
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Colombia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          37
      title
      Czech Republic
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Egypt
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          16
      title
      Spain
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          17
      title
      United Kingdom
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
      title
      Guatemala
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          181
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          272
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          56
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      title
      Black
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          21
      title
      Other
    param Type
    NUMBER
    title
    Race
    unit Of Measure
    participants
population Description
All randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      238
    2. group Id
      BG001
      value
      117
    3. group Id
      BG002
      value
      355
    units
    Participants
groups
  1. description
    Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    id
    BG000
    title
    IMC-1121B (Ramucirumab)
  2. description
    Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    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
          lower Limit
          30
          upper Limit
          86
          value
          60.0
        2. group Id
          BG001
          lower Limit
          24
          upper Limit
          87
          value
          60.0
        3. group Id
          BG002
          lower Limit
          24
          upper Limit
          87
          value
          60.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          107
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          169
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          248
        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
          41
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          60
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          197
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          295
        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
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      title
      Argentina
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
      title
      Australia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Bosnia and Herzegovina
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          38
      title
      Brazil
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
      title
      Canada
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Chile
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Colombia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          37
      title
      Czech Republic
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Egypt
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          16
      title
      Spain
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          17
      title
      United Kingdom
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
      title
      Guatemala
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          181
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          272
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          56
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      title
      Black
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          21
      title
      Other
    param Type
    NUMBER
    title
    Race
    unit Of Measure
    participants
population Description
All randomized participants.

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Preserved source evidence · Not medical advice