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NCT01716806 · BASELINE

Baseline characteristics

A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL) · Source last updated 2024-06-11

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
      27
    2. group Id
      BG001
      value
      22
    3. group Id
      BG002
      value
      20
    4. group Id
      BG003
      value
      21
    5. group Id
      BG004
      value
      30
    6. group Id
      BG005
      value
      7
    7. group Id
      BG006
      value
      127
    units
    Participants
groups
  1. description
    Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
    id
    BG000
    title
    Part A
  2. description
    BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    BG001
    title
    Part B
  3. description
    BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
    id
    BG002
    title
    Part C
  4. description
    BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    BG003
    title
    Part D
  5. description
    BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    BG004
    title
    Part E
  6. description
    BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    BG005
    title
    Part F
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          12
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          29
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          115
        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
          value
          13
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          53
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          74
        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
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          11
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          28
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          116
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        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
        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
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          26
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          117
        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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        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
          3
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          28
      title
      Grade 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          63
      title
      Grade 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          28
      title
      Grade 2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          7
      title
      Grade 3
    5. 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
      title
      Grade 4
    6. 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
      title
      Grade 5
    7. 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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
      title
      Missing
    description
    0=Normal activity, 1=Symptoms but ambulatory, 2=In bed \<50% of the time, 3=In bed \>50% of the time, 4=100% bedridden, 5=Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
The Full Analysis Set includes all participants who received any amount of brentuximab vedotin.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      27
    2. group Id
      BG001
      value
      22
    3. group Id
      BG002
      value
      20
    4. group Id
      BG003
      value
      21
    5. group Id
      BG004
      value
      30
    6. group Id
      BG005
      value
      7
    7. group Id
      BG006
      value
      127
    units
    Participants
groups
  1. description
    Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
    id
    BG000
    title
    Part A
  2. description
    BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    BG001
    title
    Part B
  3. description
    BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
    id
    BG002
    title
    Part C
  4. description
    BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    BG003
    title
    Part D
  5. description
    BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    BG004
    title
    Part E
  6. description
    BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
    id
    BG005
    title
    Part F
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          12
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          29
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          115
        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
          value
          13
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          53
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          74
        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
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          11
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          28
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          116
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        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
        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
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          26
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          117
        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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        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
          3
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          28
      title
      Grade 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          63
      title
      Grade 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          28
      title
      Grade 2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          7
      title
      Grade 3
    5. 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
      title
      Grade 4
    6. 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
      title
      Grade 5
    7. 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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
      title
      Missing
    description
    0=Normal activity, 1=Symptoms but ambulatory, 2=In bed \<50% of the time, 3=In bed \>50% of the time, 4=100% bedridden, 5=Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
The Full Analysis Set includes all participants who received any amount of brentuximab vedotin.

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Preserved source evidence · Not medical advice