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NCT01578499 · BASELINE

Baseline characteristics

A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study) · Source last updated 2021-01-05

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
      66
    2. group Id
      BG001
      value
      64
    3. group Id
      BG002
      value
      130
    units
    Participants
groups
  1. description
    Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
    id
    BG000
    title
    Brentuximab Vedotin
  2. description
    Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
    id
    BG001
    title
    Methotrexate or Bexarotene
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.80
          value
          59.4
        2. group Id
          BG001
          spread
          14.43
          value
          56.6
        3. group Id
          BG002
          spread
          14.12
          value
          58.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          61
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          67
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          109
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Not reported
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Other
    param Type
    NUMBER
    population Description
    ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          110
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Not reported
    param Type
    NUMBER
    population Description
    ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          20
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Australia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Belgium
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      France
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Germany
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Italy
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Poland
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Spain
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Switzerland
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          23
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      United Kingdom
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      United States
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Brazil
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received (n=66,62). Intent-to-treat population (ITT) population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment (n=64,64).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      66
    2. group Id
      BG001
      value
      64
    3. group Id
      BG002
      value
      130
    units
    Participants
groups
  1. description
    Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
    id
    BG000
    title
    Brentuximab Vedotin
  2. description
    Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
    id
    BG001
    title
    Methotrexate or Bexarotene
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.80
          value
          59.4
        2. group Id
          BG001
          spread
          14.43
          value
          56.6
        3. group Id
          BG002
          spread
          14.12
          value
          58.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          61
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          67
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          109
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Not reported
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Other
    param Type
    NUMBER
    population Description
    ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          110
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
      denoms
      1. counts
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Not reported
    param Type
    NUMBER
    population Description
    ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          20
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Australia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Belgium
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      France
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Germany
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Italy
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Poland
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Spain
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Switzerland
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          23
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      United Kingdom
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      United States
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          128
        units
        Participants
      title
      Brazil
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received (n=66,62). Intent-to-treat population (ITT) population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment (n=64,64).

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