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NCT01777152 · BASELINE

Baseline characteristics

ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas · Source last updated 2021-11-30

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
      226
    2. group Id
      BG001
      value
      226
    3. group Id
      BG002
      value
      452
    units
    Participants
groups
  1. description
    brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
    id
    BG000
    title
    A+CHP
  2. description
    cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
    id
    BG001
    title
    CHOP
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          157
        2. group Id
          BG001
          value
          156
        3. group Id
          BG002
          value
          313
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          139
        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
          lower Limit
          18
          upper Limit
          85
          value
          58
        2. group Id
          BG001
          lower Limit
          18
          upper Limit
          83
          value
          58
        3. group Id
          BG002
          lower Limit
          18
          upper Limit
          85
          value
          58
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          168
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          133
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          284
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          14
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          193
        3. group Id
          BG002
          value
          379
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          59
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          99
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          281
      title
      White
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          48
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          127
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          43
      title
      Japan
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          40
      title
      South Korea
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          37
      title
      Italy
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          36
      title
      France
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          27
      title
      Germany
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          26
      title
      Spain
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          22
      title
      Czechia
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          21
      title
      United Kingdom
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          14
      title
      Australia
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
      title
      Denmark
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
      title
      Israel
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          178
      title
      Grade 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          90
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          176
      title
      Grade 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          98
      title
      Grade 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. One participant (ECOG=0) was assessed after start of treatment.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      226
    2. group Id
      BG001
      value
      226
    3. group Id
      BG002
      value
      452
    units
    Participants
groups
  1. description
    brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
    id
    BG000
    title
    A+CHP
  2. description
    cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
    id
    BG001
    title
    CHOP
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          157
        2. group Id
          BG001
          value
          156
        3. group Id
          BG002
          value
          313
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          139
        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
          lower Limit
          18
          upper Limit
          85
          value
          58
        2. group Id
          BG001
          lower Limit
          18
          upper Limit
          83
          value
          58
        3. group Id
          BG002
          lower Limit
          18
          upper Limit
          85
          value
          58
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          168
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          133
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          284
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          14
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          193
        3. group Id
          BG002
          value
          379
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          59
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          99
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          281
      title
      White
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          48
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          127
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          43
      title
      Japan
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          40
      title
      South Korea
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          37
      title
      Italy
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          36
      title
      France
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          27
      title
      Germany
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          26
      title
      Spain
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          22
      title
      Czechia
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          21
      title
      United Kingdom
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          14
      title
      Australia
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
      title
      Denmark
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
      title
      Israel
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          178
      title
      Grade 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          90
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          176
      title
      Grade 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          98
      title
      Grade 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. One participant (ECOG=0) was assessed after start of treatment.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants

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