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NCT01100502 · BASELINE

Baseline characteristics

A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial) · Source last updated 2021-05-14

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
      165
    2. group Id
      BG001
      value
      164
    3. group Id
      BG002
      value
      329
    units
    Participants
groups
  1. description
    brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    id
    BG000
    title
    Brentuximab Vedotin
  2. description
    placebo every 3 weeks by IV infusion
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18
          upper Limit
          71
          value
          33
        2. group Id
          BG001
          lower Limit
          18
          upper Limit
          76
          value
          32
        3. group Id
          BG002
          lower Limit
          18
          upper Limit
          76
          value
          32
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          89
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          156
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          173
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          12
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          153
        2. group Id
          BG001
          value
          156
        3. group Id
          BG002
          value
          309
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          39
      title
      Russian Federation
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
      title
      Romania
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          20
      title
      Hungary
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          135
      title
      United States
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      title
      United Kingdom
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
      title
      Spain
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
      title
      Czech Republic
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          54
      title
      Poland
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          16
      title
      Italy
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
      title
      France
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
      title
      Serbia
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
      title
      Bulgaria
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          184
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          144
      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
    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 Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          196
      title
      Refractory
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          107
      title
      Relapse in less than 12 months
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          26
      title
      Relapse 12 months or later with extranodal disease
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hodgkin Lymphoma Status after end of Frontline Therapy
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          123
      title
      Complete remission
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          113
      title
      Partial remission
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          93
      title
      Stable disease
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Best Response to Salvage Therapy pre-ASCT
    unit Of Measure
    Participants
population Description
Intention-to-Treat analysis set
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      165
    2. group Id
      BG001
      value
      164
    3. group Id
      BG002
      value
      329
    units
    Participants
groups
  1. description
    brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    id
    BG000
    title
    Brentuximab Vedotin
  2. description
    placebo every 3 weeks by IV infusion
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18
          upper Limit
          71
          value
          33
        2. group Id
          BG001
          lower Limit
          18
          upper Limit
          76
          value
          32
        3. group Id
          BG002
          lower Limit
          18
          upper Limit
          76
          value
          32
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          89
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          156
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          173
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          12
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          153
        2. group Id
          BG001
          value
          156
        3. group Id
          BG002
          value
          309
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          39
      title
      Russian Federation
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
      title
      Romania
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          20
      title
      Hungary
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          135
      title
      United States
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      title
      United Kingdom
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
      title
      Spain
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
      title
      Czech Republic
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          54
      title
      Poland
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          16
      title
      Italy
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
      title
      France
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
      title
      Serbia
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
      title
      Bulgaria
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          184
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          144
      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
    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 Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          196
      title
      Refractory
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          107
      title
      Relapse in less than 12 months
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          26
      title
      Relapse 12 months or later with extranodal disease
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hodgkin Lymphoma Status after end of Frontline Therapy
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          123
      title
      Complete remission
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          113
      title
      Partial remission
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          93
      title
      Stable disease
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Best Response to Salvage Therapy pre-ASCT
    unit Of Measure
    Participants
population Description
Intention-to-Treat analysis set

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

Preserved source evidence · Not medical advice