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NCT02431260 · BASELINE

Baseline characteristics

An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies · Source last updated 2019-06-14

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
      5
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      4
    7. group Id
      BG006
      value
      4
    8. group Id
      BG007
      value
      3
    9. group Id
      BG008
      value
      8
    10. group Id
      BG009
      value
      8
    11. group Id
      BG010
      value
      4
    12. group Id
      BG011
      value
      4
    units
    Participants
groups
  1. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG000
    title
    Part 1 / Treatment Group A: 15 MG QD INCB054329
  2. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG001
    title
    Part 1 / Treatment Group A: 22.5 MG QD INCB054329
  3. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG002
    title
    Part 1 / Treatment Group A: 15 MG BID INCB054329
  4. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG003
    title
    Part 1 / Treatment Group A: 30 MG QD INCB054329
  5. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG004
    title
    Part 1 / Treatment Group A: 22.5 MG BID INCB054329
  6. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG005
    title
    Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
  7. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG006
    title
    Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
  8. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG007
    title
    Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
  9. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG008
    title
    Part 1 / Treatment Group A: 20 MG BID INCB054329
  10. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG009
    title
    Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
  11. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG010
    title
    Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
  12. description
    Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
    id
    BG011
    title
    Part 1 / Treatment Group B: 20 MG BID INCB054329
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.03
          value
          62.3
        2. group Id
          BG001
          spread
          13.39
          value
          54.8
        3. group Id
          BG002
          spread
          8.50
          value
          57.7
        4. group Id
          BG003
          spread
          7.86
          value
          63.6
        5. group Id
          BG004
          spread
          5.77
          value
          68.7
        6. group Id
          BG005
          spread
          21.73
          value
          49.3
        7. group Id
          BG006
          spread
          12.40
          value
          61.5
        8. group Id
          BG007
          spread
          16.20
          value
          68.3
        9. group Id
          BG008
          spread
          17.55
          value
          58.4
        10. group Id
          BG009
          spread
          14.84
          value
          60.9
        11. group Id
          BG010
          spread
          16.58
          value
          50.3
        12. group Id
          BG011
          spread
          8.77
          value
          71.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          2
        title
        Female
      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
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          5
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          2
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          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
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          4
        title
        Not Hispanic or Latino
      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
          00
        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
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          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
        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
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        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
        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
          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
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          3
        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
          0
        11. group Id
          BG010
          value
          0
        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
          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
        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
          spread
          8.02
          value
          167.3
        2. group Id
          BG001
          spread
          11.47
          value
          172.7
        3. group Id
          BG002
          spread
          9.80
          value
          169.1
        4. group Id
          BG003
          spread
          10.48
          value
          164.6
        5. group Id
          BG004
          spread
          12.12
          value
          172.0
        6. group Id
          BG005
          spread
          16.52
          value
          164.8
        7. group Id
          BG006
          spread
          16.64
          value
          170.8
        8. group Id
          BG007
          spread
          14.65
          value
          174.2
        9. group Id
          BG008
          spread
          7.05
          value
          173.6
        10. group Id
          BG009
          spread
          12.60
          value
          170.5
        11. group Id
          BG010
          spread
          7.41
          value
          179.8
        12. group Id
          BG011
          spread
          13.29
          value
          167.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.19
          value
          70.0
        2. group Id
          BG001
          spread
          11.14
          value
          66.2
        3. group Id
          BG002
          spread
          18.32
          value
          71.7
        4. group Id
          BG003
          spread
          18.30
          value
          79.7
        5. group Id
          BG004
          spread
          18.55
          value
          77.6
        6. group Id
          BG005
          spread
          19.12
          value
          70.2
        7. group Id
          BG006
          spread
          24.39
          value
          72.3
        8. group Id
          BG007
          spread
          24.18
          value
          82.3
        9. group Id
          BG008
          spread
          18.24
          value
          87.3
        10. group Id
          BG009
          spread
          23.65
          value
          77.6
        11. group Id
          BG010
          spread
          36.32
          value
          88.4
        12. group Id
          BG011
          spread
          5.85
          value
          84.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.34
          value
          25.2
        2. group Id
          BG001
          spread
          3.68
          value
          22.3
        3. group Id
          BG002
          spread
          5.00
          value
          24.8
        4. group Id
          BG003
          spread
          6.83
          value
          29.5
        5. group Id
          BG004
          spread
          4.62
          value
          26.1
        6. group Id
          BG005
          spread
          3.51
          value
          25.5
        7. group Id
          BG006
          spread
          5.10
          value
          24.3
        8. group Id
          BG007
          spread
          3.12
          value
          26.6
        9. group Id
          BG008
          spread
          4.85
          value
          28.8
        10. group Id
          BG009
          spread
          7.73
          value
          26.7
        11. group Id
          BG010
          spread
          10.69
          value
          27.2
        12. group Id
          BG011
          spread
          3.27
          value
          30.6
    description
    BMI is a measure of body fat based on height and weight that applies to adult men and women.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body mass index (BMI)
    unit Of Measure
    kg/m^2
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          5
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          1
      title
      ECOG - 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          7
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          3
      title
      ECOG - 1
    3. 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
      ECOG - >=2
    description
    ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (greater than \[\>\]50% of waking hours), capable of all self care, unable to carry out any work activities
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG)
    unit Of Measure
    Participants
population Description
The safety population included all enrolled participants who received at least 1 dose of INCB054329.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      4
    7. group Id
      BG006
      value
      4
    8. group Id
      BG007
      value
      3
    9. group Id
      BG008
      value
      8
    10. group Id
      BG009
      value
      8
    11. group Id
      BG010
      value
      4
    12. group Id
      BG011
      value
      4
    units
    Participants
groups
  1. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG000
    title
    Part 1 / Treatment Group A: 15 MG QD INCB054329
  2. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG001
    title
    Part 1 / Treatment Group A: 22.5 MG QD INCB054329
  3. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG002
    title
    Part 1 / Treatment Group A: 15 MG BID INCB054329
  4. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG003
    title
    Part 1 / Treatment Group A: 30 MG QD INCB054329
  5. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG004
    title
    Part 1 / Treatment Group A: 22.5 MG BID INCB054329
  6. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG005
    title
    Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
  7. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG006
    title
    Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
  8. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG007
    title
    Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
  9. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG008
    title
    Part 1 / Treatment Group A: 20 MG BID INCB054329
  10. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG009
    title
    Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
  11. description
    Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
    id
    BG010
    title
    Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
  12. description
    Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
    id
    BG011
    title
    Part 1 / Treatment Group B: 20 MG BID INCB054329
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.03
          value
          62.3
        2. group Id
          BG001
          spread
          13.39
          value
          54.8
        3. group Id
          BG002
          spread
          8.50
          value
          57.7
        4. group Id
          BG003
          spread
          7.86
          value
          63.6
        5. group Id
          BG004
          spread
          5.77
          value
          68.7
        6. group Id
          BG005
          spread
          21.73
          value
          49.3
        7. group Id
          BG006
          spread
          12.40
          value
          61.5
        8. group Id
          BG007
          spread
          16.20
          value
          68.3
        9. group Id
          BG008
          spread
          17.55
          value
          58.4
        10. group Id
          BG009
          spread
          14.84
          value
          60.9
        11. group Id
          BG010
          spread
          16.58
          value
          50.3
        12. group Id
          BG011
          spread
          8.77
          value
          71.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          2
        title
        Female
      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
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          5
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          2
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          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
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          4
        title
        Not Hispanic or Latino
      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
          00
        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
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          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
        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
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        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
        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
          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
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          3
        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
          0
        11. group Id
          BG010
          value
          0
        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
          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
        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
          spread
          8.02
          value
          167.3
        2. group Id
          BG001
          spread
          11.47
          value
          172.7
        3. group Id
          BG002
          spread
          9.80
          value
          169.1
        4. group Id
          BG003
          spread
          10.48
          value
          164.6
        5. group Id
          BG004
          spread
          12.12
          value
          172.0
        6. group Id
          BG005
          spread
          16.52
          value
          164.8
        7. group Id
          BG006
          spread
          16.64
          value
          170.8
        8. group Id
          BG007
          spread
          14.65
          value
          174.2
        9. group Id
          BG008
          spread
          7.05
          value
          173.6
        10. group Id
          BG009
          spread
          12.60
          value
          170.5
        11. group Id
          BG010
          spread
          7.41
          value
          179.8
        12. group Id
          BG011
          spread
          13.29
          value
          167.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.19
          value
          70.0
        2. group Id
          BG001
          spread
          11.14
          value
          66.2
        3. group Id
          BG002
          spread
          18.32
          value
          71.7
        4. group Id
          BG003
          spread
          18.30
          value
          79.7
        5. group Id
          BG004
          spread
          18.55
          value
          77.6
        6. group Id
          BG005
          spread
          19.12
          value
          70.2
        7. group Id
          BG006
          spread
          24.39
          value
          72.3
        8. group Id
          BG007
          spread
          24.18
          value
          82.3
        9. group Id
          BG008
          spread
          18.24
          value
          87.3
        10. group Id
          BG009
          spread
          23.65
          value
          77.6
        11. group Id
          BG010
          spread
          36.32
          value
          88.4
        12. group Id
          BG011
          spread
          5.85
          value
          84.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.34
          value
          25.2
        2. group Id
          BG001
          spread
          3.68
          value
          22.3
        3. group Id
          BG002
          spread
          5.00
          value
          24.8
        4. group Id
          BG003
          spread
          6.83
          value
          29.5
        5. group Id
          BG004
          spread
          4.62
          value
          26.1
        6. group Id
          BG005
          spread
          3.51
          value
          25.5
        7. group Id
          BG006
          spread
          5.10
          value
          24.3
        8. group Id
          BG007
          spread
          3.12
          value
          26.6
        9. group Id
          BG008
          spread
          4.85
          value
          28.8
        10. group Id
          BG009
          spread
          7.73
          value
          26.7
        11. group Id
          BG010
          spread
          10.69
          value
          27.2
        12. group Id
          BG011
          spread
          3.27
          value
          30.6
    description
    BMI is a measure of body fat based on height and weight that applies to adult men and women.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body mass index (BMI)
    unit Of Measure
    kg/m^2
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          5
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          1
      title
      ECOG - 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          7
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          3
      title
      ECOG - 1
    3. 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
      ECOG - >=2
    description
    ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (greater than \[\>\]50% of waking hours), capable of all self care, unable to carry out any work activities
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG)
    unit Of Measure
    Participants
population Description
The safety population included all enrolled participants who received at least 1 dose of INCB054329.

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Preserved source evidence · Not medical advice