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NCT01724177 · BASELINE

Baseline characteristics

A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma · Source last updated 2018-05-29

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
      26
    units
    Participants
groups
  1. description
    Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity.
    id
    BG000
    title
    Lenalidomide
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.20
          value
          67.5
    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
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        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
          13
      title
      0 = Fully Active
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      1 = Restrictive but Ambulatory
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      2 = Ambulatory but Unable to Work
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      3 = Limited Self-Care
    description
    ECOG performance status is used by doctors and researchers to assess how a subject's disease is progressing, assess how the disease affects the daily living activities of the subject and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
    param Type
    NUMBER
    population Description
    Intent to Treat population was defined as all participants who were enrolled in this study independent of whether they received lenalidomide or not.
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
Intent to treat population consisted of all participants enrolled independent of whether they received study treatment or not.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      26
    units
    Participants
groups
  1. description
    Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity.
    id
    BG000
    title
    Lenalidomide
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.20
          value
          67.5
    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
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        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
          13
      title
      0 = Fully Active
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      1 = Restrictive but Ambulatory
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      2 = Ambulatory but Unable to Work
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      3 = Limited Self-Care
    description
    ECOG performance status is used by doctors and researchers to assess how a subject's disease is progressing, assess how the disease affects the daily living activities of the subject and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
    param Type
    NUMBER
    population Description
    Intent to Treat population was defined as all participants who were enrolled in this study independent of whether they received lenalidomide or not.
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
Intent to treat population consisted of all participants enrolled independent of whether they received study treatment or not.

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Preserved source evidence · Independent clinical review pending · Not medical advice