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NCT02257567 · BASELINE

Baseline characteristics

A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma · Source last updated 2022-11-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      39
    6. group Id
      BG005
      value
      41
    7. group Id
      BG006
      value
      40
    8. group Id
      BG007
      value
      40
    9. group Id
      BG008
      value
      20
    10. group Id
      BG009
      value
      21
    11. group Id
      BG010
      value
      106
    12. group Id
      BG011
      value
      331
    units
    Participants
groups
  1. description
    Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
    id
    BG000
    title
    Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL
  2. description
    Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
    id
    BG001
    title
    Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL
  3. description
    Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
    id
    BG002
    title
    Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
  4. description
    Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
    id
    BG003
    title
    Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
  5. description
    Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
    id
    BG004
    title
    Arm A (Phase II Randomization): Pola+BR in FL
  6. description
    Participants with FL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.
    id
    BG005
    title
    Arm B (Phase II Randomization): BR in FL
  7. description
    Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
    id
    BG006
    title
    Arm C (Phase II Randomization): Pola+BR in DLBCL
  8. description
    Participants with DLBCL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.
    id
    BG007
    title
    Arm D (Phase II Randomization): BR in DLBCL
  9. description
    Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
    id
    BG008
    title
    Arm E (Phase II Expansion): Pola+BG in FL
  10. description
    Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
    id
    BG009
    title
    Arm F (Phase II Expansion): Pola+BG in DLBCL
  11. description
    Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
    id
    BG010
    title
    Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL
  12. description
    Total of all reporting groups
    id
    BG011
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          54
          upper Limit
          73
          value
          68.0
        2. group Id
          BG001
          lower Limit
          58
          upper Limit
          79
          value
          65.0
        3. group Id
          BG002
          lower Limit
          42
          upper Limit
          73
          value
          63.5
        4. group Id
          BG003
          lower Limit
          53
          upper Limit
          84
          value
          71.0
        5. group Id
          BG004
          lower Limit
          37
          upper Limit
          74
          value
          65.0
        6. group Id
          BG005
          lower Limit
          39
          upper Limit
          80
          value
          63.0
        7. group Id
          BG006
          lower Limit
          33
          upper Limit
          86
          value
          67.0
        8. group Id
          BG007
          lower Limit
          30
          upper Limit
          84
          value
          71.0
        9. group Id
          BG008
          lower Limit
          37
          upper Limit
          86
          value
          60.5
        10. group Id
          BG009
          lower Limit
          26
          upper Limit
          86
          value
          65.0
        11. group Id
          BG010
          lower Limit
          24
          upper Limit
          94
          value
          70.0
        12. group Id
          BG011
          lower Limit
          24
          upper Limit
          94
          value
          67.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          23
        7. group Id
          BG006
          value
          12
        8. group Id
          BG007
          value
          15
        9. group Id
          BG008
          value
          10
        10. group Id
          BG009
          value
          10
        11. group Id
          BG010
          value
          54
        12. group Id
          BG011
          value
          151
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          21
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          28
        8. group Id
          BG007
          value
          25
        9. group Id
          BG008
          value
          10
        10. group Id
          BG009
          value
          11
        11. group Id
          BG010
          value
          52
        12. group Id
          BG011
          value
          180
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        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
          6
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          30
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          33
        6. group Id
          BG005
          value
          33
        7. group Id
          BG006
          value
          26
        8. group Id
          BG007
          value
          31
        9. group Id
          BG008
          value
          16
        10. group Id
          BG009
          value
          15
        11. group Id
          BG010
          value
          83
        12. group Id
          BG011
          value
          259
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          14
        12. group Id
          BG011
          value
          34
        title
        Unknown or Not Reported
    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
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          14
        title
        Hispanic or Latino
      2. measurements
        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
          34
        6. group Id
          BG005
          value
          34
        7. group Id
          BG006
          value
          35
        8. group Id
          BG007
          value
          36
        9. group Id
          BG008
          value
          16
        10. group Id
          BG009
          value
          19
        11. group Id
          BG010
          value
          87
        12. group Id
          BG011
          value
          285
        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
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          13
        12. group Id
          BG011
          value
          22
        title
        Not Stated
      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
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          10
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) population included all participants who were randomized, whether or not the participants received the assigned treatment.
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
      39
    6. group Id
      BG005
      value
      41
    7. group Id
      BG006
      value
      40
    8. group Id
      BG007
      value
      40
    9. group Id
      BG008
      value
      20
    10. group Id
      BG009
      value
      21
    11. group Id
      BG010
      value
      106
    12. group Id
      BG011
      value
      331
    units
    Participants
groups
  1. description
    Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
    id
    BG000
    title
    Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL
  2. description
    Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
    id
    BG001
    title
    Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL
  3. description
    Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
    id
    BG002
    title
    Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
  4. description
    Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
    id
    BG003
    title
    Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
  5. description
    Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
    id
    BG004
    title
    Arm A (Phase II Randomization): Pola+BR in FL
  6. description
    Participants with FL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.
    id
    BG005
    title
    Arm B (Phase II Randomization): BR in FL
  7. description
    Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
    id
    BG006
    title
    Arm C (Phase II Randomization): Pola+BR in DLBCL
  8. description
    Participants with DLBCL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.
    id
    BG007
    title
    Arm D (Phase II Randomization): BR in DLBCL
  9. description
    Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
    id
    BG008
    title
    Arm E (Phase II Expansion): Pola+BG in FL
  10. description
    Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
    id
    BG009
    title
    Arm F (Phase II Expansion): Pola+BG in DLBCL
  11. description
    Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
    id
    BG010
    title
    Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL
  12. description
    Total of all reporting groups
    id
    BG011
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          54
          upper Limit
          73
          value
          68.0
        2. group Id
          BG001
          lower Limit
          58
          upper Limit
          79
          value
          65.0
        3. group Id
          BG002
          lower Limit
          42
          upper Limit
          73
          value
          63.5
        4. group Id
          BG003
          lower Limit
          53
          upper Limit
          84
          value
          71.0
        5. group Id
          BG004
          lower Limit
          37
          upper Limit
          74
          value
          65.0
        6. group Id
          BG005
          lower Limit
          39
          upper Limit
          80
          value
          63.0
        7. group Id
          BG006
          lower Limit
          33
          upper Limit
          86
          value
          67.0
        8. group Id
          BG007
          lower Limit
          30
          upper Limit
          84
          value
          71.0
        9. group Id
          BG008
          lower Limit
          37
          upper Limit
          86
          value
          60.5
        10. group Id
          BG009
          lower Limit
          26
          upper Limit
          86
          value
          65.0
        11. group Id
          BG010
          lower Limit
          24
          upper Limit
          94
          value
          70.0
        12. group Id
          BG011
          lower Limit
          24
          upper Limit
          94
          value
          67.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          23
        7. group Id
          BG006
          value
          12
        8. group Id
          BG007
          value
          15
        9. group Id
          BG008
          value
          10
        10. group Id
          BG009
          value
          10
        11. group Id
          BG010
          value
          54
        12. group Id
          BG011
          value
          151
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          21
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          28
        8. group Id
          BG007
          value
          25
        9. group Id
          BG008
          value
          10
        10. group Id
          BG009
          value
          11
        11. group Id
          BG010
          value
          52
        12. group Id
          BG011
          value
          180
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        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
          6
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          30
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          33
        6. group Id
          BG005
          value
          33
        7. group Id
          BG006
          value
          26
        8. group Id
          BG007
          value
          31
        9. group Id
          BG008
          value
          16
        10. group Id
          BG009
          value
          15
        11. group Id
          BG010
          value
          83
        12. group Id
          BG011
          value
          259
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          14
        12. group Id
          BG011
          value
          34
        title
        Unknown or Not Reported
    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
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          14
        title
        Hispanic or Latino
      2. measurements
        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
          34
        6. group Id
          BG005
          value
          34
        7. group Id
          BG006
          value
          35
        8. group Id
          BG007
          value
          36
        9. group Id
          BG008
          value
          16
        10. group Id
          BG009
          value
          19
        11. group Id
          BG010
          value
          87
        12. group Id
          BG011
          value
          285
        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
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          13
        12. group Id
          BG011
          value
          22
        title
        Not Stated
      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
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          10
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) population included all participants who were randomized, whether or not the participants received the assigned treatment.

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Preserved source evidence · Not medical advice