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NCT00106431 · BASELINE

Baseline characteristics

A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL) · Source last updated 2019-10-30

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
      102
    units
    Participants
groups
  1. description
    Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
    id
    BG000
    title
    Romidepsin
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          79
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          23
        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
          spread
          11.93
          value
          57.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          62
        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
          5
      title
      France
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      title
      Poland
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Russian Federation
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Germany
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      United Kingdom
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Georgia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Ukraine
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          53
      title
      0, Fully active, able to carry on all pre-disease
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          49
      title
      1, Restricted in physically strenuous activity but
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      2, Ambulatory and capable of all selfcare but unab
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      102
    units
    Participants
groups
  1. description
    Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
    id
    BG000
    title
    Romidepsin
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          79
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          23
        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
          spread
          11.93
          value
          57.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          62
        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
          5
      title
      France
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      title
      Poland
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Russian Federation
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Germany
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      United Kingdom
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Georgia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Ukraine
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          53
      title
      0, Fully active, able to carry on all pre-disease
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          49
      title
      1, Restricted in physically strenuous activity but
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      2, Ambulatory and capable of all selfcare but unab
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance status
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice