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NCT01401530 · BASELINE

Baseline characteristics

E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma · Source last updated 2018-11-23

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
      3
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      13
    units
    Participants
groups
  1. description
    Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
    id
    BG000
    title
    Cohort 1: 6 ug/kg/Day Denileukin Diftitox
  2. description
    Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
    id
    BG001
    title
    Cohort 2: 9 ug/kg/Day Denileukin Diftitox
  3. description
    Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
    id
    BG002
    title
    Cohort 3: 12 ug/kg/Day Denileukin Diftitox
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.51
          value
          69.7
        2. group Id
          BG001
          spread
          17.74
          value
          49.9
        3. group Id
          BG002
          spread
          4.16
          value
          66.3
        4. group Id
          BG003
          spread
          15.98
          value
          58.2
    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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Safety analysis set included all participants who received at least one dose of the study drug with at least one evaluable, post-baseline safety datum.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      13
    units
    Participants
groups
  1. description
    Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
    id
    BG000
    title
    Cohort 1: 6 ug/kg/Day Denileukin Diftitox
  2. description
    Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
    id
    BG001
    title
    Cohort 2: 9 ug/kg/Day Denileukin Diftitox
  3. description
    Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
    id
    BG002
    title
    Cohort 3: 12 ug/kg/Day Denileukin Diftitox
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.51
          value
          69.7
        2. group Id
          BG001
          spread
          17.74
          value
          49.9
        3. group Id
          BG002
          spread
          4.16
          value
          66.3
        4. group Id
          BG003
          spread
          15.98
          value
          58.2
    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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Safety analysis set included all participants who received at least one dose of the study drug with at least one evaluable, post-baseline safety datum.

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Preserved source evidence · Not medical advice