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NCT02508532 · BASELINE

Baseline characteristics

(NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors · Source last updated 2022-06-21

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
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      3
    7. group Id
      BG006
      value
      217
    8. group Id
      BG007
      value
      250
    units
    Participants
groups
  1. description
    Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    BG000
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD
  2. description
    Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    BG001
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD
  3. description
    Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    BG002
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD
  4. description
    Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    BG003
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD
  5. description
    Part 1: Patients received a starting dose of 200 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. .
    id
    BG004
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD
  6. description
    Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    BG005
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD
  7. description
    Part 1 and Part 2: Patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD were included in the Part1/Part 2 safety and efficacy analysis. Patients received avapritinib in continuous 28 day cycles until discontinuation. Includes 13 patients from Part 1
    id
    BG006
    title
    Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 mg or 400 mg QD
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.21
          value
          58.7
        2. group Id
          BG001
          spread
          6.77
          value
          60.2
        3. group Id
          BG002
          spread
          11.84
          value
          60.2
        4. group Id
          BG003
          spread
          10.05
          value
          61.5
        5. group Id
          BG004
          spread
          8.31
          value
          61.7
        6. group Id
          BG005
          spread
          20.82
          value
          48.3
        7. group Id
          BG006
          spread
          11.00
          value
          59.4
        8. group Id
          BG007
          spread
          10.97
          value
          59.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
    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
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          84
        8. group Id
          BG007
          value
          96
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          133
        8. group Id
          BG007
          value
          154
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
    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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        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
          0
        7. group Id
          BG006
          value
          22
        8. group Id
          BG007
          value
          22
        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
          1
        8. group Id
          BG007
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          12
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          154
        8. group Id
          BG007
          value
          181
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          28
        8. group Id
          BG007
          value
          32
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (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
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          13
        8. group Id
          BG007
          value
          16
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      Belgium
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          20
        8. group Id
          BG007
          value
          24
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      France
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        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
          14
        8. group Id
          BG007
          value
          18
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      Germany
    4. categories
      1. 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
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          12
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      Netherlands
    5. 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
          8
        8. group Id
          BG007
          value
          8
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      Poland
    6. 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
          17
        8. group Id
          BG007
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      South Korea
    7. 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
          11
        8. group Id
          BG007
          value
          11
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      Spain
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          23
        8. group Id
          BG007
          value
          28
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      United Kingdom
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          100
        8. group Id
          BG007
          value
          116
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.22
          value
          24.78
        2. group Id
          BG001
          spread
          8.63
          value
          31.61
        3. group Id
          BG002
          spread
          3.76
          value
          28.33
        4. group Id
          BG003
          spread
          2.71
          value
          23.78
        5. group Id
          BG004
          spread
          5.16
          value
          24.63
        6. group Id
          BG005
          spread
          4.54
          value
          27.15
        7. group Id
          BG006
          spread
          6.22
          value
          25.98
        8. group Id
          BG007
          spread
          6.15
          value
          26.09
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          198
        8. group Id
          BG007
          value
          228
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Body Mass Index was only calculated for patients with both a height and weight measurement at Baseline
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m2
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      3
    7. group Id
      BG006
      value
      217
    8. group Id
      BG007
      value
      250
    units
    Participants
groups
  1. description
    Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    BG000
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD
  2. description
    Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    BG001
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD
  3. description
    Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    BG002
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD
  4. description
    Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    BG003
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD
  5. description
    Part 1: Patients received a starting dose of 200 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. .
    id
    BG004
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD
  6. description
    Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    BG005
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD
  7. description
    Part 1 and Part 2: Patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD were included in the Part1/Part 2 safety and efficacy analysis. Patients received avapritinib in continuous 28 day cycles until discontinuation. Includes 13 patients from Part 1
    id
    BG006
    title
    Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 mg or 400 mg QD
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.21
          value
          58.7
        2. group Id
          BG001
          spread
          6.77
          value
          60.2
        3. group Id
          BG002
          spread
          11.84
          value
          60.2
        4. group Id
          BG003
          spread
          10.05
          value
          61.5
        5. group Id
          BG004
          spread
          8.31
          value
          61.7
        6. group Id
          BG005
          spread
          20.82
          value
          48.3
        7. group Id
          BG006
          spread
          11.00
          value
          59.4
        8. group Id
          BG007
          spread
          10.97
          value
          59.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
    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
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          84
        8. group Id
          BG007
          value
          96
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          133
        8. group Id
          BG007
          value
          154
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
    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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        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
          0
        7. group Id
          BG006
          value
          22
        8. group Id
          BG007
          value
          22
        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
          1
        8. group Id
          BG007
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          12
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          154
        8. group Id
          BG007
          value
          181
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          28
        8. group Id
          BG007
          value
          32
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (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
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          13
        8. group Id
          BG007
          value
          16
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      Belgium
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          20
        8. group Id
          BG007
          value
          24
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      France
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        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
          14
        8. group Id
          BG007
          value
          18
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      Germany
    4. categories
      1. 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
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          12
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      Netherlands
    5. 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
          8
        8. group Id
          BG007
          value
          8
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      Poland
    6. 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
          17
        8. group Id
          BG007
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      South Korea
    7. 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
          11
        8. group Id
          BG007
          value
          11
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      Spain
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          23
        8. group Id
          BG007
          value
          28
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      United Kingdom
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          100
        8. group Id
          BG007
          value
          116
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          217
        8. group Id
          BG007
          value
          250
        units
        Participants
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.22
          value
          24.78
        2. group Id
          BG001
          spread
          8.63
          value
          31.61
        3. group Id
          BG002
          spread
          3.76
          value
          28.33
        4. group Id
          BG003
          spread
          2.71
          value
          23.78
        5. group Id
          BG004
          spread
          5.16
          value
          24.63
        6. group Id
          BG005
          spread
          4.54
          value
          27.15
        7. group Id
          BG006
          spread
          6.22
          value
          25.98
        8. group Id
          BG007
          spread
          6.15
          value
          26.09
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          198
        8. group Id
          BG007
          value
          228
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Body Mass Index was only calculated for patients with both a height and weight measurement at Baseline
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m2

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