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NCT02432274 · BASELINE

Baseline characteristics

Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma · Source last updated 2023-07-11

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
      3
    2. group Id
      BG001
      value
      9
    3. group Id
      BG002
      value
      11
    4. group Id
      BG003
      value
      1
    5. group Id
      BG004
      value
      31
    6. group Id
      BG005
      value
      7
    7. group Id
      BG006
      value
      15
    8. group Id
      BG007
      value
      20
    9. group Id
      BG008
      value
      97
    units
    Participants
groups
  1. description
    Participants (age group 2 to \<6 years and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 11 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Eligible participants of age group 2 to \<6 years first underwent 21-days run-in period with lenvatinib 5 mg/m\^2, once daily before receiving lenvatinib 11 mg/m\^2 in Cycle 1 in Cohort 1. Duration of each treatment cycle in Cohort 1=28 days. After determining RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
    id
    BG000
    title
    Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2
  2. description
    Participants (age group 2 to \<6 years and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Eligible participants of age group 2 to \<6 years first underwent 21-days run-in period with lenvatinib 5 mg/m\^2, once daily before receiving lenvatinib 14 mg/m\^2 in Cycle 1 in Cohort 1. Duration of each treatment cycle in Cohort 1=28 days. After determining RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
    id
    BG001
    title
    Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2
  3. description
    Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days. After determining the RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
    id
    BG002
    title
    Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
  4. description
    Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
    id
    BG003
    title
    Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2
  5. description
    Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
    id
    BG004
    title
    Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
  6. description
    Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.
    id
    BG005
    title
    Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
  7. description
    Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.
    id
    BG006
    title
    Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
  8. description
    Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
    id
    BG007
    title
    Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. 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
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          3
      title
      2 to <6 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          24
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          15
        9. group Id
          BG008
          value
          77
      title
      6 to <18 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          17
      title
      18 to <=25 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          43
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          13
        9. group Id
          BG008
          value
          54
        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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          16
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          47
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          34
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          13
        9. group Id
          BG008
          value
          64
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          6
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          27
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Full analysis set included all enrolled participants who did not fail study screening.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      9
    3. group Id
      BG002
      value
      11
    4. group Id
      BG003
      value
      1
    5. group Id
      BG004
      value
      31
    6. group Id
      BG005
      value
      7
    7. group Id
      BG006
      value
      15
    8. group Id
      BG007
      value
      20
    9. group Id
      BG008
      value
      97
    units
    Participants
groups
  1. description
    Participants (age group 2 to \<6 years and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 11 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Eligible participants of age group 2 to \<6 years first underwent 21-days run-in period with lenvatinib 5 mg/m\^2, once daily before receiving lenvatinib 11 mg/m\^2 in Cycle 1 in Cohort 1. Duration of each treatment cycle in Cohort 1=28 days. After determining RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
    id
    BG000
    title
    Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2
  2. description
    Participants (age group 2 to \<6 years and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Eligible participants of age group 2 to \<6 years first underwent 21-days run-in period with lenvatinib 5 mg/m\^2, once daily before receiving lenvatinib 14 mg/m\^2 in Cycle 1 in Cohort 1. Duration of each treatment cycle in Cohort 1=28 days. After determining RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
    id
    BG001
    title
    Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2
  3. description
    Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days. After determining the RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
    id
    BG002
    title
    Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
  4. description
    Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
    id
    BG003
    title
    Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2
  5. description
    Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
    id
    BG004
    title
    Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
  6. description
    Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.
    id
    BG005
    title
    Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
  7. description
    Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.
    id
    BG006
    title
    Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
  8. description
    Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
    id
    BG007
    title
    Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. 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
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          3
      title
      2 to <6 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          24
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          11
        8. group Id
          BG007
          value
          15
        9. group Id
          BG008
          value
          77
      title
      6 to <18 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          17
      title
      18 to <=25 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          43
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          13
        9. group Id
          BG008
          value
          54
        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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          16
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          47
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          34
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          14
        8. group Id
          BG007
          value
          13
        9. group Id
          BG008
          value
          64
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          6
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          27
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Full analysis set included all enrolled participants who did not fail study screening.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice