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NCT01950364 · BASELINE

Baseline characteristics

A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma · Source last updated 2016-05-11

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
      10
    2. group Id
      BG001
      value
      10
    3. group Id
      BG002
      value
      20
    units
    Participants
groups
  1. description
    Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
    id
    BG000
    title
    Brentuximab Vedotin
  2. description
    Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
    id
    BG001
    title
    Brentuximab Vedotin + Rifampicin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.15
          value
          42.3
        2. group Id
          BG001
          spread
          9.13
          value
          40.1
        3. group Id
          BG002
          spread
          10.52
          value
          41.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        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
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
      title
      White
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
      title
      Not Hispanic or Latino
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
      title
      Spain
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Belgium
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
      title
      Lithuania
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.056
          value
          71.11
        2. group Id
          BG001
          spread
          24.213
          value
          76.84
        3. group Id
          BG002
          spread
          20.595
          value
          73.98
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilogram (kg)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.80
          value
          169.9
        2. group Id
          BG001
          spread
          6.45
          value
          169.7
        3. group Id
          BG002
          spread
          5.15
          value
          169.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    centimeter (cm)
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      2
    description
    ECOG performance status is used to assess how the disease affects the daily living abilities of the participant. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for less than (\<) 50 percent (%) of the time; 3= in bed for greater than (\>) 50% of the time; 4= 100% bedridden; 5= dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
      title
      Hodgkin lymphoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      sALCL
    param Type
    NUMBER
    title
    Disease Type
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          31.23
          value
          34.7
        2. group Id
          BG001
          spread
          46.96
          value
          61.9
        3. group Id
          BG002
          spread
          41.25
          value
          48.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Months from Initial Diagnosis to First Dose
    unit Of Measure
    months
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
      title
      IV
    description
    Ann Arbor staging is staging system for lymphomas. The stage is determined by location of tumor. Stage I (located in a single region, usually 1 lymph node and surrounding area), Stage II (located in 2 separate regions, an affected lymph node or organ and a second affected area, and both affected areas are confined to 1 side of diaphragm), Stage III (spread to both sides of diaphragm, including organ/area near lymph nodes/spleen), Stage IV (diffuse or disseminated involvement of 1 or more extra lymphatic organs, including any involvement of liver, bone marrow or nodular involvement of lungs).
    param Type
    NUMBER
    title
    Ann Arbor Stage
    unit Of Measure
    participants
population Description
Safety population included all participants who received at least 1 dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      10
    2. group Id
      BG001
      value
      10
    3. group Id
      BG002
      value
      20
    units
    Participants
groups
  1. description
    Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
    id
    BG000
    title
    Brentuximab Vedotin
  2. description
    Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
    id
    BG001
    title
    Brentuximab Vedotin + Rifampicin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.15
          value
          42.3
        2. group Id
          BG001
          spread
          9.13
          value
          40.1
        3. group Id
          BG002
          spread
          10.52
          value
          41.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        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
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
      title
      White
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
      title
      Not Hispanic or Latino
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
      title
      Spain
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Belgium
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
      title
      Lithuania
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.056
          value
          71.11
        2. group Id
          BG001
          spread
          24.213
          value
          76.84
        3. group Id
          BG002
          spread
          20.595
          value
          73.98
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilogram (kg)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.80
          value
          169.9
        2. group Id
          BG001
          spread
          6.45
          value
          169.7
        3. group Id
          BG002
          spread
          5.15
          value
          169.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    centimeter (cm)
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      2
    description
    ECOG performance status is used to assess how the disease affects the daily living abilities of the participant. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for less than (\<) 50 percent (%) of the time; 3= in bed for greater than (\>) 50% of the time; 4= 100% bedridden; 5= dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
      title
      Hodgkin lymphoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      sALCL
    param Type
    NUMBER
    title
    Disease Type
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          31.23
          value
          34.7
        2. group Id
          BG001
          spread
          46.96
          value
          61.9
        3. group Id
          BG002
          spread
          41.25
          value
          48.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Months from Initial Diagnosis to First Dose
    unit Of Measure
    months
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
      title
      IV
    description
    Ann Arbor staging is staging system for lymphomas. The stage is determined by location of tumor. Stage I (located in a single region, usually 1 lymph node and surrounding area), Stage II (located in 2 separate regions, an affected lymph node or organ and a second affected area, and both affected areas are confined to 1 side of diaphragm), Stage III (spread to both sides of diaphragm, including organ/area near lymph nodes/spleen), Stage IV (diffuse or disseminated involvement of 1 or more extra lymphatic organs, including any involvement of liver, bone marrow or nodular involvement of lungs).
    param Type
    NUMBER
    title
    Ann Arbor Stage
    unit Of Measure
    participants
population Description
Safety population included all participants who received at least 1 dose of study drug.

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Preserved source evidence · Not medical advice