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NCT02443324 · BASELINE

Baseline characteristics

A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer · Source last updated 2024-07-31

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
      24
    2. group Id
      BG001
      value
      26
    3. group Id
      BG002
      value
      28
    4. group Id
      BG003
      value
      17
    5. group Id
      BG004
      value
      27
    6. group Id
      BG005
      value
      24
    7. group Id
      BG006
      value
      26
    8. group Id
      BG007
      value
      172
    units
    Participants
groups
  1. description
    Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    BG000
    title
    Cohort A
  2. description
    Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    BG001
    title
    Cohort A1
  3. description
    Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    BG002
    title
    Cohort A2
  4. description
    Participants with Gastric-GEJ cancer (Second-Third L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    BG003
    title
    Cohort B
  5. description
    Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    BG004
    title
    Cohort C
  6. description
    Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    BG005
    title
    Cohort D
  7. description
    Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    BG006
    title
    Cohort E
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          24.0
          upper Limit
          78.0
          value
          56.0
        2. group Id
          BG001
          lower Limit
          36.0
          upper Limit
          78.0
          value
          62.5
        3. group Id
          BG002
          lower Limit
          31.0
          upper Limit
          83.0
          value
          63.0
        4. group Id
          BG003
          lower Limit
          28.0
          upper Limit
          73.0
          value
          61.0
        5. group Id
          BG004
          lower Limit
          34.0
          upper Limit
          82.0
          value
          65.0
        6. group Id
          BG005
          lower Limit
          45.0
          upper Limit
          87.0
          value
          63.0
        7. group Id
          BG006
          lower Limit
          42.0
          upper Limit
          85.0
          value
          63.0
        8. group Id
          BG007
          lower Limit
          24.0
          upper Limit
          87.0
          value
          61.28
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          65
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          21
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          12
        8. group Id
          BG007
          value
          107
        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
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          20
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          21
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          25
        8. group Id
          BG007
          value
          123
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          29
        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
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          4
        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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          26
        6. group Id
          BG005
          value
          22
        7. group Id
          BG006
          value
          22
        8. group Id
          BG007
          value
          145
        title
        White
      6. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          18
        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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          47
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          51
      title
      United Kingdom
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          25
      title
      France
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          8
      title
      Germany
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          41
      title
      Spain
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All enrolled participants who received at least one dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      24
    2. group Id
      BG001
      value
      26
    3. group Id
      BG002
      value
      28
    4. group Id
      BG003
      value
      17
    5. group Id
      BG004
      value
      27
    6. group Id
      BG005
      value
      24
    7. group Id
      BG006
      value
      26
    8. group Id
      BG007
      value
      172
    units
    Participants
groups
  1. description
    Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    BG000
    title
    Cohort A
  2. description
    Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    BG001
    title
    Cohort A1
  3. description
    Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    BG002
    title
    Cohort A2
  4. description
    Participants with Gastric-GEJ cancer (Second-Third L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    BG003
    title
    Cohort B
  5. description
    Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    BG004
    title
    Cohort C
  6. description
    Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    BG005
    title
    Cohort D
  7. description
    Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    BG006
    title
    Cohort E
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          24.0
          upper Limit
          78.0
          value
          56.0
        2. group Id
          BG001
          lower Limit
          36.0
          upper Limit
          78.0
          value
          62.5
        3. group Id
          BG002
          lower Limit
          31.0
          upper Limit
          83.0
          value
          63.0
        4. group Id
          BG003
          lower Limit
          28.0
          upper Limit
          73.0
          value
          61.0
        5. group Id
          BG004
          lower Limit
          34.0
          upper Limit
          82.0
          value
          65.0
        6. group Id
          BG005
          lower Limit
          45.0
          upper Limit
          87.0
          value
          63.0
        7. group Id
          BG006
          lower Limit
          42.0
          upper Limit
          85.0
          value
          63.0
        8. group Id
          BG007
          lower Limit
          24.0
          upper Limit
          87.0
          value
          61.28
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          65
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          21
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          12
        8. group Id
          BG007
          value
          107
        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
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          20
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          21
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          25
        8. group Id
          BG007
          value
          123
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          29
        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
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          4
        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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          26
        6. group Id
          BG005
          value
          22
        7. group Id
          BG006
          value
          22
        8. group Id
          BG007
          value
          145
        title
        White
      6. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          18
        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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          47
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          51
      title
      United Kingdom
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          25
      title
      France
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          8
      title
      Germany
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          41
      title
      Spain
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All enrolled participants who received at least one dose of study drug.

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Preserved source evidence · Not medical advice