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NCT03046953 · BASELINE

Baseline characteristics

Avelumab in Relapsed and Refractory Peripheral T-cell Lymphoma · Source last updated 2024-07-16

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
      35
    units
    Participants
groups
  1. description
    Patients received Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days. Avelumab: anti-PDL1 antibody
    id
    BG000
    title
    Avelumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.7
          value
          62.1
      denoms
      1. counts
        1. group Id
          BG000
          value
          35
        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
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          29
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          35
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          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
          17
        title
        Peripheral T-cell lymphoma not otherwise specified
      2. measurements
        1. group Id
          BG000
          value
          11
        title
        Angioimmunoblastic T-cell lymphoma
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        Extranodal NK/T-cell lymphoma
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Anaplastic large cell lymphoma
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        Transformed mycosis fungoides
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Missing data
      denoms
      1. counts
        1. group Id
          BG000
          value
          35
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2.0
          upper Limit
          3.0
          value
          3.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          35
        units
        Participants
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Prior therapies
    unit Of Measure
    years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          13
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        2
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Missing Data
      denoms
      1. counts
        1. group Id
          BG000
          value
          35
        units
        Participants
    description
    GRADE ECOG PERFORMANCE STATUS 0 Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG performance
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.3
          value
          81.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    Includes all patients eligible at registration
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    1 patient ineligible post registration
    title
    Weight
    unit Of Measure
    kg
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.1
          value
          1.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    Includes all patients eligible at registration
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    1 patient was ineligible post registration
    title
    Height
    unit Of Measure
    metres
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.1
          value
          27.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    Includes all patients eligible at registration
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    1 patient was ineligible post registration
    title
    BMI
    unit Of Measure
    kg/m2
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          19.7
          value
          127.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    Includes all patients eligible at registration
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    1 patient was ineligible post registration
    title
    Systolic blood pressure
    unit Of Measure
    mmHg
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.8
          value
          74.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    Includes all patients eligible at registration
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    1 patient was ineligible post registration
    title
    Diastolic blood pressure
    unit Of Measure
    mmHg
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          21.7
          value
          83.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    Includes all patients eligible at registration
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    1 patient was ineligible post registration
    title
    Pulse
    unit Of Measure
    bpm
population Description
Intention to treat population was 35
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      35
    units
    Participants
groups
  1. description
    Patients received Avelumab 10mg/kg by IV infusion once every 2 weeks. A maximum of 8 cycles, each cycle is 28 days. Avelumab: anti-PDL1 antibody
    id
    BG000
    title
    Avelumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.7
          value
          62.1
      denoms
      1. counts
        1. group Id
          BG000
          value
          35
        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
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          29
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          35
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          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
          17
        title
        Peripheral T-cell lymphoma not otherwise specified
      2. measurements
        1. group Id
          BG000
          value
          11
        title
        Angioimmunoblastic T-cell lymphoma
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        Extranodal NK/T-cell lymphoma
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Anaplastic large cell lymphoma
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        Transformed mycosis fungoides
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Missing data
      denoms
      1. counts
        1. group Id
          BG000
          value
          35
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2.0
          upper Limit
          3.0
          value
          3.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          35
        units
        Participants
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Prior therapies
    unit Of Measure
    years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          13
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        2
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Missing Data
      denoms
      1. counts
        1. group Id
          BG000
          value
          35
        units
        Participants
    description
    GRADE ECOG PERFORMANCE STATUS 0 Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG performance
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.3
          value
          81.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    Includes all patients eligible at registration
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    1 patient ineligible post registration
    title
    Weight
    unit Of Measure
    kg
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.1
          value
          1.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    Includes all patients eligible at registration
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    1 patient was ineligible post registration
    title
    Height
    unit Of Measure
    metres
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.1
          value
          27.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    Includes all patients eligible at registration
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    1 patient was ineligible post registration
    title
    BMI
    unit Of Measure
    kg/m2
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          19.7
          value
          127.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    Includes all patients eligible at registration
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    1 patient was ineligible post registration
    title
    Systolic blood pressure
    unit Of Measure
    mmHg
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.8
          value
          74.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    Includes all patients eligible at registration
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    1 patient was ineligible post registration
    title
    Diastolic blood pressure
    unit Of Measure
    mmHg
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          21.7
          value
          83.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          34
        units
        Participants
    description
    Includes all patients eligible at registration
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    1 patient was ineligible post registration
    title
    Pulse
    unit Of Measure
    bpm
population Description
Intention to treat population was 35

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Preserved source evidence · Not medical advice