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NCT01803282 · BASELINE

Baseline characteristics

Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors · Source last updated 2020-06-02

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
      4
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      36
    5. group Id
      BG004
      value
      10
    6. group Id
      BG005
      value
      10
    7. group Id
      BG006
      value
      40
    8. group Id
      BG007
      value
      45
    9. group Id
      BG008
      value
      11
    10. group Id
      BG009
      value
      44
    11. group Id
      BG010
      value
      8
    12. group Id
      BG011
      value
      15
    units
    Participants
groups
  1. description
    Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG000
    title
    Part A: ADX 200 mg
  2. description
    Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG001
    title
    Part A: ADX 600 mg
  3. description
    Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG002
    title
    Part A: ADX 1800 mg
  4. description
    Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG003
    title
    Part B: PAC, ADX 800 mg
  5. description
    Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG004
    title
    Part B: LAC, ADX 1200 mg
  6. description
    Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG005
    title
    Part B: LSC, ADX 1200 mg
  7. description
    Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG006
    title
    Part B: EGC, ADX 800 mg
  8. description
    Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG007
    title
    Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
  9. description
    Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG008
    title
    Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
  10. description
    Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG009
    title
    Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
  11. description
    Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG010
    title
    Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
  12. description
    Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG011
    title
    Part B: BRCA, ADX 800 mg
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          25
        8. group Id
          BG007
          value
          26
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          33
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          10
        title
        < 65 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          15
        8. group Id
          BG007
          value
          19
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          11
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          5
        title
        ≥ 65 years
      title
      Age
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          9
        8. group Id
          BG007
          value
          19
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          25
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          31
        8. group Id
          BG007
          value
          26
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          19
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          2
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          30
        8. group Id
          BG007
          value
          39
        9. group Id
          BG008
          value
          10
        10. group Id
          BG009
          value
          39
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          12
        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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          6
        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
          1
        title
        Not Permitted
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        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
          1
        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
          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
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        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
          3
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          1
        title
        Black or African American
      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
          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
        Native Hawaiian or Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          33
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          31
        8. group Id
          BG007
          value
          35
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          35
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          12
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        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
          6
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Not Permitted
      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
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          1
        title
        Other
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      36
    5. group Id
      BG004
      value
      10
    6. group Id
      BG005
      value
      10
    7. group Id
      BG006
      value
      40
    8. group Id
      BG007
      value
      45
    9. group Id
      BG008
      value
      11
    10. group Id
      BG009
      value
      44
    11. group Id
      BG010
      value
      8
    12. group Id
      BG011
      value
      15
    units
    Participants
groups
  1. description
    Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG000
    title
    Part A: ADX 200 mg
  2. description
    Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG001
    title
    Part A: ADX 600 mg
  3. description
    Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG002
    title
    Part A: ADX 1800 mg
  4. description
    Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG003
    title
    Part B: PAC, ADX 800 mg
  5. description
    Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG004
    title
    Part B: LAC, ADX 1200 mg
  6. description
    Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG005
    title
    Part B: LSC, ADX 1200 mg
  7. description
    Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG006
    title
    Part B: EGC, ADX 800 mg
  8. description
    Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG007
    title
    Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
  9. description
    Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG008
    title
    Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
  10. description
    Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG009
    title
    Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
  11. description
    Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG010
    title
    Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
  12. description
    Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    BG011
    title
    Part B: BRCA, ADX 800 mg
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          25
        8. group Id
          BG007
          value
          26
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          33
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          10
        title
        < 65 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          15
        8. group Id
          BG007
          value
          19
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          11
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          5
        title
        ≥ 65 years
      title
      Age
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          9
        8. group Id
          BG007
          value
          19
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          25
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          31
        8. group Id
          BG007
          value
          26
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          19
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          2
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          30
        8. group Id
          BG007
          value
          39
        9. group Id
          BG008
          value
          10
        10. group Id
          BG009
          value
          39
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          12
        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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          6
        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
          1
        title
        Not Permitted
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        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
          1
        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
          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
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        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
          3
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          1
        title
        Black or African American
      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
          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
        Native Hawaiian or Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          33
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          31
        8. group Id
          BG007
          value
          35
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          35
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          12
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        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
          6
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Not Permitted
      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
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          1
        title
        Other
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).

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