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NCT01059786 · BASELINE

Baseline characteristics

Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia · Source last updated 2026-07-22

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
      28
    4. group Id
      BG003
      value
      28
    5. group Id
      BG004
      value
      1
    6. group Id
      BG005
      value
      69
    units
    Participants
groups
  1. description
    Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 70 mg/m\^2 for initial tolerability study (closed) Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles 6 participants to bendamustine 70 mg/m\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
    id
    BG000
    title
    Non-Randomized to 70 mg/m2 Bendamustine-Rituximab
  2. description
    Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 for initial tolerability study (closed) Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 6 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated
    id
    BG001
    title
    Non-randomized to 90 mg/m^2 Bendamustine-Rituximab
  3. description
    Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 Rituximab: 28 participants Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine:28 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
    id
    BG002
    title
    Randomized to 90 mg/m^2 Bendamustine-Rituximab
  4. description
    Treatment Assignment Code 2 (TAC 2) Rituximab + Pentostatin Pentostatin: 28 participants to pentostatin 4 mg/m\^2 days 1 and 15 of each cycle. Rituximab: Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
    id
    BG003
    title
    Randomized to Pentostatin-Rituximab
  5. description
    Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 or Rituxan + Pentostatin After initial tolerability studies are completed. Non-randomize up to 4 total participants to Bendamustine and/or Pentostatin with Rituximab Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 1-4 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle Pentostatin 1-4 participants to pentostatin 4 mg/m\^2 days 1 and 15 of each cycle. Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
    id
    BG004
    title
    Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab
  6. description
    Total of all reporting groups
    id
    BG005
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          39
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          30
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.03
          value
          66.65
        2. group Id
          BG001
          spread
          3.14
          value
          58.67
        3. group Id
          BG002
          spread
          9.75
          value
          61.87
        4. group Id
          BG003
          spread
          12.23
          value
          61.55
        5. group Id
          BG004
          spread
          0
          value
          71.2
        6. group Id
          BG005
          spread
          10.14
          value
          62.01
    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
          0
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          57
        title
        Male
    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
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          67
        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
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        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
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          27
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          65
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          28
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          69
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      28
    4. group Id
      BG003
      value
      28
    5. group Id
      BG004
      value
      1
    6. group Id
      BG005
      value
      69
    units
    Participants
groups
  1. description
    Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 70 mg/m\^2 for initial tolerability study (closed) Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles 6 participants to bendamustine 70 mg/m\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
    id
    BG000
    title
    Non-Randomized to 70 mg/m2 Bendamustine-Rituximab
  2. description
    Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 for initial tolerability study (closed) Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 6 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated
    id
    BG001
    title
    Non-randomized to 90 mg/m^2 Bendamustine-Rituximab
  3. description
    Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 Rituximab: 28 participants Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine:28 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
    id
    BG002
    title
    Randomized to 90 mg/m^2 Bendamustine-Rituximab
  4. description
    Treatment Assignment Code 2 (TAC 2) Rituximab + Pentostatin Pentostatin: 28 participants to pentostatin 4 mg/m\^2 days 1 and 15 of each cycle. Rituximab: Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
    id
    BG003
    title
    Randomized to Pentostatin-Rituximab
  5. description
    Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 or Rituxan + Pentostatin After initial tolerability studies are completed. Non-randomize up to 4 total participants to Bendamustine and/or Pentostatin with Rituximab Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 1-4 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle Pentostatin 1-4 participants to pentostatin 4 mg/m\^2 days 1 and 15 of each cycle. Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
    id
    BG004
    title
    Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab
  6. description
    Total of all reporting groups
    id
    BG005
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          39
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          30
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.03
          value
          66.65
        2. group Id
          BG001
          spread
          3.14
          value
          58.67
        3. group Id
          BG002
          spread
          9.75
          value
          61.87
        4. group Id
          BG003
          spread
          12.23
          value
          61.55
        5. group Id
          BG004
          spread
          0
          value
          71.2
        6. group Id
          BG005
          spread
          10.14
          value
          62.01
    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
          0
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          57
        title
        Male
    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
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          67
        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
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        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
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          27
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          65
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          28
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          69
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice