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NCT04213209 · BASELINE

Baseline characteristics

Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma" · Source last updated 2024-09-27

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
      31
    2. group Id
      BG001
      value
      35
    3. group Id
      BG002
      value
      14
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      4
    7. group Id
      BG006
      value
      94
    units
    Participants
groups
  1. description
    Adult participants with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    BG000
    title
    Adult Participants With PTCL-NOS
  2. description
    Adult participants with angioimmunoblastic T-cell lymphoma (AITL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    BG001
    title
    Adult Participants With AITL
  3. description
    Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    BG002
    title
    Adult Participants With ATLL
  4. description
    Adult participants with the other PTCL (peripheral T-cell lymphoma \[PTCL\] subtypes other than anaplastic large-cell lymphoma \[ALCL\] \[not surveyed\], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    BG003
    title
    Adult Participants With Other PTCL
  5. description
    Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    BG004
    title
    Pediatric Participants With PTCL
  6. description
    Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    BG005
    title
    Pediatric Participants With HL
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.01
          value
          69.9
        2. group Id
          BG001
          spread
          9.23
          value
          72.6
        3. group Id
          BG002
          spread
          12.82
          value
          68.0
        4. group Id
          BG003
          spread
          23.52
          value
          49.2
        5. group Id
          BG004
          spread
          3.69
          value
          12.3
        6. group Id
          BG005
          spread
          4.24
          value
          12.0
        7. group Id
          BG006
          spread
          20.47
          value
          64.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          48
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          46
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG006
          value
          0
      denoms
      1. counts
        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
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
      title
      Japan
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          42.96
          value
          35.7
        2. group Id
          BG001
          spread
          36.30
          value
          31.0
        3. group Id
          BG002
          spread
          64.90
          value
          37.2
        4. group Id
          BG003
          spread
          8.57
          value
          5.7
        5. group Id
          BG004
          spread
          2.94
          value
          5.0
        6. group Id
          BG005
          spread
          12.69
          value
          18.3
        7. group Id
          BG006
          spread
          42.01
          value
          30.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    description
    Mean duration between the first diagnosis of relapsed or refractory CD30 positive peripheral T-cell lymphoma (PTCL) or Hodgkin lymphoma (HL: pediatric participants only) and the first dose was reported.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Duration of Diagnosis of PTCL or HL
    unit Of Measure
    Months
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          35
        title
        Scale = 0
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          41
        title
        Scale = 1
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          11
        title
        Scale = 2
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          5
        title
        Scale = 3
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        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
          2
        title
        Scale = 4
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    description
    Eastern Cooperative Oncology Group performance status assess participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than \[\>\] 50 percent \[%\] of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited selfcare, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          15
        title
        Outpatient
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          79
        title
        Inpatient
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Healthcare Category
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          30
        title
        Had No Medical Complications
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          64
        title
        Had Medical Complications
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    description
    Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Medical Complications
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          61
        title
        Had No Medical History
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          32
        title
        Had Medical History
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        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
          1
        title
        Unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    description
    Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above. Unknown: Data could not be collected.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Medical History
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          44
        title
        Never Smoked
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        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
          5
        title
        Current Smoker
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          29
        title
        Ex-Smoker
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          16
        title
        Unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    description
    Unknown: Data could not be collected.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking Classification
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.031
          value
          57.65
        2. group Id
          BG001
          spread
          12.328
          value
          54.01
        3. group Id
          BG002
          spread
          10.082
          value
          52.14
        4. group Id
          BG003
          spread
          12.517
          value
          56.77
        5. group Id
          BG004
          spread
          7.677
          value
          41.75
        6. group Id
          BG005
          spread
          21.386
          value
          47.00
        7. group Id
          BG006
          spread
          12.167
          value
          54.29
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    Kilograms (kg)
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.536
          value
          22.20
        2. group Id
          BG001
          spread
          3.764
          value
          21.85
        3. group Id
          BG002
          spread
          4.059
          value
          20.86
        4. group Id
          BG003
          spread
          5.033
          value
          22.43
        5. group Id
          BG004
          spread
          2.981
          value
          18.08
        6. group Id
          BG005
          spread
          5.239
          value
          20.73
        7. group Id
          BG006
          spread
          3.858
          value
          21.65
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    description
    Body Mass Index = weight (kg)/\[height (m)\^2\]
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    BMI
    unit Of Measure
    Kilogram (kg)/meter (m)^2
population Description
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      31
    2. group Id
      BG001
      value
      35
    3. group Id
      BG002
      value
      14
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      4
    7. group Id
      BG006
      value
      94
    units
    Participants
groups
  1. description
    Adult participants with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    BG000
    title
    Adult Participants With PTCL-NOS
  2. description
    Adult participants with angioimmunoblastic T-cell lymphoma (AITL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    BG001
    title
    Adult Participants With AITL
  3. description
    Adult participants with adult T-cell leukemia/lymphoma (ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    BG002
    title
    Adult Participants With ATLL
  4. description
    Adult participants with the other PTCL (peripheral T-cell lymphoma \[PTCL\] subtypes other than anaplastic large-cell lymphoma \[ALCL\] \[not surveyed\], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    BG003
    title
    Adult Participants With Other PTCL
  5. description
    Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    BG004
    title
    Pediatric Participants With PTCL
  6. description
    Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    BG005
    title
    Pediatric Participants With HL
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.01
          value
          69.9
        2. group Id
          BG001
          spread
          9.23
          value
          72.6
        3. group Id
          BG002
          spread
          12.82
          value
          68.0
        4. group Id
          BG003
          spread
          23.52
          value
          49.2
        5. group Id
          BG004
          spread
          3.69
          value
          12.3
        6. group Id
          BG005
          spread
          4.24
          value
          12.0
        7. group Id
          BG006
          spread
          20.47
          value
          64.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          48
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          46
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG006
          value
          0
      denoms
      1. counts
        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
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
      title
      Japan
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          42.96
          value
          35.7
        2. group Id
          BG001
          spread
          36.30
          value
          31.0
        3. group Id
          BG002
          spread
          64.90
          value
          37.2
        4. group Id
          BG003
          spread
          8.57
          value
          5.7
        5. group Id
          BG004
          spread
          2.94
          value
          5.0
        6. group Id
          BG005
          spread
          12.69
          value
          18.3
        7. group Id
          BG006
          spread
          42.01
          value
          30.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    description
    Mean duration between the first diagnosis of relapsed or refractory CD30 positive peripheral T-cell lymphoma (PTCL) or Hodgkin lymphoma (HL: pediatric participants only) and the first dose was reported.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Duration of Diagnosis of PTCL or HL
    unit Of Measure
    Months
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          35
        title
        Scale = 0
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          41
        title
        Scale = 1
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          11
        title
        Scale = 2
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          5
        title
        Scale = 3
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        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
          2
        title
        Scale = 4
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    description
    Eastern Cooperative Oncology Group performance status assess participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than \[\>\] 50 percent \[%\] of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited selfcare, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          15
        title
        Outpatient
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          79
        title
        Inpatient
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Healthcare Category
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          30
        title
        Had No Medical Complications
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          64
        title
        Had Medical Complications
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    description
    Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Medical Complications
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          61
        title
        Had No Medical History
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          32
        title
        Had Medical History
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        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
          1
        title
        Unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    description
    Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above. Unknown: Data could not be collected.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Medical History
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          44
        title
        Never Smoked
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        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
          5
        title
        Current Smoker
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          29
        title
        Ex-Smoker
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          16
        title
        Unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    description
    Unknown: Data could not be collected.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking Classification
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.031
          value
          57.65
        2. group Id
          BG001
          spread
          12.328
          value
          54.01
        3. group Id
          BG002
          spread
          10.082
          value
          52.14
        4. group Id
          BG003
          spread
          12.517
          value
          56.77
        5. group Id
          BG004
          spread
          7.677
          value
          41.75
        6. group Id
          BG005
          spread
          21.386
          value
          47.00
        7. group Id
          BG006
          spread
          12.167
          value
          54.29
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    Kilograms (kg)
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.536
          value
          22.20
        2. group Id
          BG001
          spread
          3.764
          value
          21.85
        3. group Id
          BG002
          spread
          4.059
          value
          20.86
        4. group Id
          BG003
          spread
          5.033
          value
          22.43
        5. group Id
          BG004
          spread
          2.981
          value
          18.08
        6. group Id
          BG005
          spread
          5.239
          value
          20.73
        7. group Id
          BG006
          spread
          3.858
          value
          21.65
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          94
        units
        Participants
    description
    Body Mass Index = weight (kg)/\[height (m)\^2\]
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    BMI
    unit Of Measure
    Kilogram (kg)/meter (m)^2
population Description
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

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