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NCT00274651 · BASELINE

Baseline characteristics

A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas · Source last updated 2015-07-28

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
      29
    2. group Id
      BG001
      value
      24
    3. group Id
      BG002
      value
      53
    units
    Participants
groups
  1. description
    CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    id
    BG000
    title
    CTCL (ITT Population)
  2. description
    PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    id
    BG001
    title
    PTCL (ITT Population)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.4
          value
          64.1
        2. group Id
          BG001
          spread
          15.9
          value
          58.8
        3. group Id
          BG002
          spread
          14.7
          value
          61.7
    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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          29
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          22
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
        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
          22
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          39
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      France
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Israel
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
      title
      Thailand
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Patients received PXD101, 1000 mg/m2/day over 30 minutes days 1-5 of a 21-day cycle. Patients with OR or stable disease were permitted to continue with PXD101 for up to 8 cycles or until progressive disease. Patients with PR or SD could continue therapy beyond 8 cycles until progression in consultation with Investigators and Sponsor.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      29
    2. group Id
      BG001
      value
      24
    3. group Id
      BG002
      value
      53
    units
    Participants
groups
  1. description
    CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    id
    BG000
    title
    CTCL (ITT Population)
  2. description
    PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    id
    BG001
    title
    PTCL (ITT Population)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.4
          value
          64.1
        2. group Id
          BG001
          spread
          15.9
          value
          58.8
        3. group Id
          BG002
          spread
          14.7
          value
          61.7
    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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          29
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          22
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
        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
          22
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          39
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      France
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Israel
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
      title
      Thailand
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Patients received PXD101, 1000 mg/m2/day over 30 minutes days 1-5 of a 21-day cycle. Patients with OR or stable disease were permitted to continue with PXD101 for up to 8 cycles or until progressive disease. Patients with PR or SD could continue therapy beyond 8 cycles until progression in consultation with Investigators and Sponsor.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice