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NCT02564900 · BASELINE

Baseline characteristics

Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors · Source last updated 2024-01-22

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
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      49
    8. group Id
      BG007
      value
      62
    9. group Id
      BG008
      value
      20
    10. group Id
      BG009
      value
      33
    11. group Id
      BG010
      value
      17
    12. group Id
      BG011
      value
      24
    units
    Participants
groups
  1. description
    Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG000
    title
    Dose Escalation: Cohort 1, 0.8 mg/kg
  2. description
    Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG001
    title
    Dose Escalation: Cohort 2, 1.6 mg/kg
  3. description
    Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG002
    title
    Dose Escalation: Cohort 3, 3.2 mg/kg
  4. description
    Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG003
    title
    Dose Escalation: Cohort 4, 5.4 mg/kg
  5. description
    Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG004
    title
    Dose Escalation: Cohort 5, 6.4 mg/kg
  6. description
    Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG005
    title
    Dose Escalation: Cohort 6, 8.0 mg/kg
  7. description
    Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG006
    title
    Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
  8. description
    Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG007
    title
    Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
  9. description
    Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG008
    title
    Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
  10. description
    Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG009
    title
    Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
  11. description
    Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG010
    title
    Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
  12. description
    Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG011
    title
    Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
measures
  1. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          33
        8. group Id
          BG007
          value
          48
        9. group Id
          BG008
          value
          14
        10. group Id
          BG009
          value
          25
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          8
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          16
        8. group Id
          BG007
          value
          14
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          11
        12. group Id
          BG011
          value
          16
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.09
          value
          59.3
        2. group Id
          BG001
          spread
          4.73
          value
          66.3
        3. group Id
          BG002
          spread
          14.57
          value
          48.3
        4. group Id
          BG003
          spread
          14.82
          value
          66.8
        5. group Id
          BG004
          spread
          10.40
          value
          58.2
        6. group Id
          BG005
          spread
          10.67
          value
          66.2
        7. group Id
          BG006
          spread
          12.11
          value
          56.2
        8. group Id
          BG007
          spread
          10.28
          value
          54.9
        9. group Id
          BG008
          spread
          9.68
          value
          57.8
        10. group Id
          BG009
          spread
          10.97
          value
          56.3
        11. group Id
          BG010
          spread
          11.00
          value
          64.2
        12. group Id
          BG011
          spread
          8.55
          value
          66.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          48
        8. group Id
          BG007
          value
          62
        9. group Id
          BG008
          value
          20
        10. group Id
          BG009
          value
          33
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          4
        title
        Female
      2. 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
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          12
        12. group Id
          BG011
          value
          20
        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
          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
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          25
        8. group Id
          BG007
          value
          40
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          23
        11. group Id
          BG010
          value
          11
        12. group Id
          BG011
          value
          24
        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
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          19
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          7
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          0
        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
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          30
        8. group Id
          BG007
          value
          25
        9. group Id
          BG008
          value
          16
        10. group Id
          BG009
          value
          11
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          0
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          37
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          22
        11. group Id
          BG010
          value
          12
        12. group Id
          BG011
          value
          24
      title
      Japan
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Demographic and baseline characteristics were assessed in the Enrolled Analysis Set (Dose Escalation, n=27; Dose Expansion, n=265).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      49
    8. group Id
      BG007
      value
      62
    9. group Id
      BG008
      value
      20
    10. group Id
      BG009
      value
      33
    11. group Id
      BG010
      value
      17
    12. group Id
      BG011
      value
      24
    units
    Participants
groups
  1. description
    Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG000
    title
    Dose Escalation: Cohort 1, 0.8 mg/kg
  2. description
    Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG001
    title
    Dose Escalation: Cohort 2, 1.6 mg/kg
  3. description
    Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG002
    title
    Dose Escalation: Cohort 3, 3.2 mg/kg
  4. description
    Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG003
    title
    Dose Escalation: Cohort 4, 5.4 mg/kg
  5. description
    Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG004
    title
    Dose Escalation: Cohort 5, 6.4 mg/kg
  6. description
    Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG005
    title
    Dose Escalation: Cohort 6, 8.0 mg/kg
  7. description
    Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG006
    title
    Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
  8. description
    Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG007
    title
    Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
  9. description
    Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG008
    title
    Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
  10. description
    Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG009
    title
    Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
  11. description
    Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG010
    title
    Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
  12. description
    Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    BG011
    title
    Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
measures
  1. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          33
        8. group Id
          BG007
          value
          48
        9. group Id
          BG008
          value
          14
        10. group Id
          BG009
          value
          25
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          8
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          16
        8. group Id
          BG007
          value
          14
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          11
        12. group Id
          BG011
          value
          16
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.09
          value
          59.3
        2. group Id
          BG001
          spread
          4.73
          value
          66.3
        3. group Id
          BG002
          spread
          14.57
          value
          48.3
        4. group Id
          BG003
          spread
          14.82
          value
          66.8
        5. group Id
          BG004
          spread
          10.40
          value
          58.2
        6. group Id
          BG005
          spread
          10.67
          value
          66.2
        7. group Id
          BG006
          spread
          12.11
          value
          56.2
        8. group Id
          BG007
          spread
          10.28
          value
          54.9
        9. group Id
          BG008
          spread
          9.68
          value
          57.8
        10. group Id
          BG009
          spread
          10.97
          value
          56.3
        11. group Id
          BG010
          spread
          11.00
          value
          64.2
        12. group Id
          BG011
          spread
          8.55
          value
          66.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          48
        8. group Id
          BG007
          value
          62
        9. group Id
          BG008
          value
          20
        10. group Id
          BG009
          value
          33
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          4
        title
        Female
      2. 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
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          12
        12. group Id
          BG011
          value
          20
        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
          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
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          25
        8. group Id
          BG007
          value
          40
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          23
        11. group Id
          BG010
          value
          11
        12. group Id
          BG011
          value
          24
        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
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          19
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          7
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          0
        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
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          30
        8. group Id
          BG007
          value
          25
        9. group Id
          BG008
          value
          16
        10. group Id
          BG009
          value
          11
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          0
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          37
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          22
        11. group Id
          BG010
          value
          12
        12. group Id
          BG011
          value
          24
      title
      Japan
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Demographic and baseline characteristics were assessed in the Enrolled Analysis Set (Dose Escalation, n=27; Dose Expansion, n=265).

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