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NCT02669017 · BASELINE

Baseline characteristics

Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL) · Source last updated 2021-05-19

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
      4
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      16
    6. group Id
      BG005
      value
      26
    7. group Id
      BG006
      value
      19
    8. group Id
      BG007
      value
      69
    9. group Id
      BG008
      value
      36
    10. group Id
      BG009
      value
      183
    units
    Participants
groups
  1. description
    Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG000
    title
    Part 1: 15 μg/kg Q3W
  2. description
    Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG001
    title
    Part 1: 30 μg/kg Q3W
  3. description
    Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG002
    title
    Part 1: 60 μg/kg Q3W
  4. description
    Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG003
    title
    Part 1: 90 μg/kg Q3W
  5. description
    Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG004
    title
    Part 1: 120 μg/kg Q3W
  6. description
    Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG005
    title
    Part 2: 120 μg/kg Q3W
  7. description
    Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG006
    title
    Part 1: 150 μg/kg Q3W
  8. description
    Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG007
    title
    Part 2: 150 μg/kg Q3W
  9. description
    Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
    id
    BG008
    title
    Part 1: 200 μg/kg Q3W and Q6W
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          13
        8. group Id
          BG007
          value
          43
        9. group Id
          BG008
          value
          19
        10. group Id
          BG009
          value
          99
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          12
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          26
        9. group Id
          BG008
          value
          17
        10. group Id
          BG009
          value
          84
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          69
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          183
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.39
          value
          72.5
        2. group Id
          BG001
          spread
          11.53
          value
          68.3
        3. group Id
          BG002
          spread
          18.82
          value
          51.3
        4. group Id
          BG003
          spread
          12.38
          value
          68.2
        5. group Id
          BG004
          spread
          10.20
          value
          71.0
        6. group Id
          BG005
          spread
          13.37
          value
          63.7
        7. group Id
          BG006
          spread
          13.96
          value
          58.5
        8. group Id
          BG007
          spread
          15.82
          value
          58.7
        9. group Id
          BG008
          spread
          12.82
          value
          61.7
        10. group Id
          BG009
          spread
          14.49
          value
          61.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          69
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          183
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          34
        9. group Id
          BG008
          value
          10
        10. group Id
          BG009
          value
          69
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          19
        7. group Id
          BG006
          value
          13
        8. group Id
          BG007
          value
          35
        9. group Id
          BG008
          value
          26
        10. group Id
          BG009
          value
          114
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          69
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          183
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          25
        7. group Id
          BG006
          value
          18
        8. group Id
          BG007
          value
          65
        9. group Id
          BG008
          value
          35
        10. group Id
          BG009
          value
          176
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          69
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          183
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          19
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          61
        9. group Id
          BG008
          value
          35
        10. group Id
          BG009
          value
          164
        title
        White
      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
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          11
        title
        Black or African American
      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
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          3
        title
        Asian
      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
        title
        American Indian or Alaskan Native
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          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
        title
        Native Hawaiian or Pacific Islander
      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
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        title
        Other
      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
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          69
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          183
        units
        Participants
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          18.438
          value
          172.23
        2. group Id
          BG001
          spread
          12.545
          value
          170.73
        3. group Id
          BG002
          spread
          11.544
          value
          173.65
        4. group Id
          BG003
          spread
          10.275
          value
          167.68
        5. group Id
          BG004
          spread
          8.977
          value
          170.72
        6. group Id
          BG005
          spread
          9.790
          value
          171.47
        7. group Id
          BG006
          spread
          10.584
          value
          172.79
        8. group Id
          BG007
          spread
          11.908
          value
          170.56
        9. group Id
          BG008
          spread
          12.193
          value
          171.29
        10. group Id
          BG009
          spread
          11.221
          value
          171.11
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          68
        9. group Id
          BG008
          value
          35
        10. group Id
          BG009
          value
          181
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Height data was not collected for 2 participants because of complications during the collection of baseline measurements.
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.204
          value
          73.65
        2. group Id
          BG001
          spread
          25.445
          value
          78.73
        3. group Id
          BG002
          spread
          26.942
          value
          79.95
        4. group Id
          BG003
          spread
          23.597
          value
          86.38
        5. group Id
          BG004
          spread
          25.996
          value
          86.89
        6. group Id
          BG005
          spread
          18.113
          value
          78.66
        7. group Id
          BG006
          spread
          20.820
          value
          88.67
        8. group Id
          BG007
          spread
          22.453
          value
          77.87
        9. group Id
          BG008
          spread
          24.834
          value
          88.71
        10. group Id
          BG009
          spread
          22.635
          value
          82.23
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          69
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          183
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.971
          value
          25.21
        2. group Id
          BG001
          spread
          5.466
          value
          26.60
        3. group Id
          BG002
          spread
          5.428
          value
          25.89
        4. group Id
          BG003
          spread
          8.931
          value
          30.77
        5. group Id
          BG004
          spread
          6.882
          value
          29.40
        6. group Id
          BG005
          spread
          5.458
          value
          26.68
        7. group Id
          BG006
          spread
          5.575
          value
          29.57
        8. group Id
          BG007
          spread
          6.648
          value
          26.62
        9. group Id
          BG008
          spread
          7.235
          value
          30.15
        10. group Id
          BG009
          spread
          6.587
          value
          27.93
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          68
        9. group Id
          BG008
          value
          35
        10. group Id
          BG009
          value
          181
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    BMI could not be calculated for 2 participants due to missing height information.
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          54
        title
        0: Fully Active
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          19
        7. group Id
          BG006
          value
          12
        8. group Id
          BG007
          value
          36
        9. group Id
          BG008
          value
          21
        10. group Id
          BG009
          value
          106
        title
        1: Restricted in Physical Activity; Ambulatory
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          12
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          21
        title
        2: Ambulatory and Capable of All Self-care
      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
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        title
        3: Capable of Only Limited Self-care
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          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
        title
        4: Completely Disabled
      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
        title
        5: Dead
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          69
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          183
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
All participants who received at least one dose of study treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      16
    6. group Id
      BG005
      value
      26
    7. group Id
      BG006
      value
      19
    8. group Id
      BG007
      value
      69
    9. group Id
      BG008
      value
      36
    10. group Id
      BG009
      value
      183
    units
    Participants
groups
  1. description
    Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG000
    title
    Part 1: 15 μg/kg Q3W
  2. description
    Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG001
    title
    Part 1: 30 μg/kg Q3W
  3. description
    Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG002
    title
    Part 1: 60 μg/kg Q3W
  4. description
    Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG003
    title
    Part 1: 90 μg/kg Q3W
  5. description
    Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG004
    title
    Part 1: 120 μg/kg Q3W
  6. description
    Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG005
    title
    Part 2: 120 μg/kg Q3W
  7. description
    Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG006
    title
    Part 1: 150 μg/kg Q3W
  8. description
    Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    BG007
    title
    Part 2: 150 μg/kg Q3W
  9. description
    Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
    id
    BG008
    title
    Part 1: 200 μg/kg Q3W and Q6W
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          13
        8. group Id
          BG007
          value
          43
        9. group Id
          BG008
          value
          19
        10. group Id
          BG009
          value
          99
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          12
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          26
        9. group Id
          BG008
          value
          17
        10. group Id
          BG009
          value
          84
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          69
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          183
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.39
          value
          72.5
        2. group Id
          BG001
          spread
          11.53
          value
          68.3
        3. group Id
          BG002
          spread
          18.82
          value
          51.3
        4. group Id
          BG003
          spread
          12.38
          value
          68.2
        5. group Id
          BG004
          spread
          10.20
          value
          71.0
        6. group Id
          BG005
          spread
          13.37
          value
          63.7
        7. group Id
          BG006
          spread
          13.96
          value
          58.5
        8. group Id
          BG007
          spread
          15.82
          value
          58.7
        9. group Id
          BG008
          spread
          12.82
          value
          61.7
        10. group Id
          BG009
          spread
          14.49
          value
          61.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          69
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          183
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          34
        9. group Id
          BG008
          value
          10
        10. group Id
          BG009
          value
          69
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          19
        7. group Id
          BG006
          value
          13
        8. group Id
          BG007
          value
          35
        9. group Id
          BG008
          value
          26
        10. group Id
          BG009
          value
          114
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          69
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          183
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          25
        7. group Id
          BG006
          value
          18
        8. group Id
          BG007
          value
          65
        9. group Id
          BG008
          value
          35
        10. group Id
          BG009
          value
          176
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          69
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          183
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          19
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          61
        9. group Id
          BG008
          value
          35
        10. group Id
          BG009
          value
          164
        title
        White
      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
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          11
        title
        Black or African American
      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
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          3
        title
        Asian
      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
        title
        American Indian or Alaskan Native
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          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
        title
        Native Hawaiian or Pacific Islander
      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
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        title
        Other
      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
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          69
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          183
        units
        Participants
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          18.438
          value
          172.23
        2. group Id
          BG001
          spread
          12.545
          value
          170.73
        3. group Id
          BG002
          spread
          11.544
          value
          173.65
        4. group Id
          BG003
          spread
          10.275
          value
          167.68
        5. group Id
          BG004
          spread
          8.977
          value
          170.72
        6. group Id
          BG005
          spread
          9.790
          value
          171.47
        7. group Id
          BG006
          spread
          10.584
          value
          172.79
        8. group Id
          BG007
          spread
          11.908
          value
          170.56
        9. group Id
          BG008
          spread
          12.193
          value
          171.29
        10. group Id
          BG009
          spread
          11.221
          value
          171.11
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          68
        9. group Id
          BG008
          value
          35
        10. group Id
          BG009
          value
          181
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Height data was not collected for 2 participants because of complications during the collection of baseline measurements.
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.204
          value
          73.65
        2. group Id
          BG001
          spread
          25.445
          value
          78.73
        3. group Id
          BG002
          spread
          26.942
          value
          79.95
        4. group Id
          BG003
          spread
          23.597
          value
          86.38
        5. group Id
          BG004
          spread
          25.996
          value
          86.89
        6. group Id
          BG005
          spread
          18.113
          value
          78.66
        7. group Id
          BG006
          spread
          20.820
          value
          88.67
        8. group Id
          BG007
          spread
          22.453
          value
          77.87
        9. group Id
          BG008
          spread
          24.834
          value
          88.71
        10. group Id
          BG009
          spread
          22.635
          value
          82.23
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          69
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          183
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.971
          value
          25.21
        2. group Id
          BG001
          spread
          5.466
          value
          26.60
        3. group Id
          BG002
          spread
          5.428
          value
          25.89
        4. group Id
          BG003
          spread
          8.931
          value
          30.77
        5. group Id
          BG004
          spread
          6.882
          value
          29.40
        6. group Id
          BG005
          spread
          5.458
          value
          26.68
        7. group Id
          BG006
          spread
          5.575
          value
          29.57
        8. group Id
          BG007
          spread
          6.648
          value
          26.62
        9. group Id
          BG008
          spread
          7.235
          value
          30.15
        10. group Id
          BG009
          spread
          6.587
          value
          27.93
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          68
        9. group Id
          BG008
          value
          35
        10. group Id
          BG009
          value
          181
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    BMI could not be calculated for 2 participants due to missing height information.
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          54
        title
        0: Fully Active
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          19
        7. group Id
          BG006
          value
          12
        8. group Id
          BG007
          value
          36
        9. group Id
          BG008
          value
          21
        10. group Id
          BG009
          value
          106
        title
        1: Restricted in Physical Activity; Ambulatory
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          12
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          21
        title
        2: Ambulatory and Capable of All Self-care
      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
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        title
        3: Capable of Only Limited Self-care
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          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
        title
        4: Completely Disabled
      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
        title
        5: Dead
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          19
        8. group Id
          BG007
          value
          69
        9. group Id
          BG008
          value
          36
        10. group Id
          BG009
          value
          183
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
All participants who received at least one dose of study treatment.

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Preserved source evidence · Not medical advice