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NCT01456039 · BASELINE

Baseline characteristics

A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL) · Source last updated 2019-02-11

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
      40
    4. group Id
      BG003
      value
      50
    units
    Participants
groups
  1. description
    Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
    id
    BG000
    title
    Phase 1: Romidepsin 9mg/m^2
  2. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    BG001
    title
    Phase 1: Romidepsin 14mg/m^2
  3. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    BG002
    title
    Phase 2: Romidepsin 14mg/m^2
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.54
          value
          59.0
        2. group Id
          BG001
          spread
          4.20
          value
          73.6
        3. group Id
          BG002
          spread
          8.43
          value
          68.5
        4. group Id
          BG003
          spread
          8.47
          value
          68.7
    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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          14
      title
      <65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          36
      title
      ≥65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          21
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          29
        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
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          48
      title
      PTCL
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      CTCL
    description
    PTCL is included in a heterogenous group of rare diseases resulting from clonal proliferation of mature thymic lymphocytes. These T-cell tumors account for about 10% to 15% of all lymphoid tumors. CTCL is a non-Hodgkin's lymphoma of helper T-cells that usually presents in the skin. It is classified mainly into mycosis fungoides and Sézary syndrome, and the stage is classified by the Tumor Node Metastasis Blood (TNMB) classification.
    param Type
    NUMBER
    title
    Disease Type by Investigator
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          26
      title
      0 = (Fully Active)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          17
      title
      1 = (Restrictive but ambulatory)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          7
      title
      2 = (Ambulatory but unable to work)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
      title
      3 = (Limited self care)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
      title
      4 = (Completely Disabled)
    description
    Eastern Cooperative Oncology Group (ECOG) performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant 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
    title
    Eastern Cooperative Oncology Group (ECOG)
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.1114
          value
          1.640
        2. group Id
          BG001
          spread
          0.2034
          value
          1.563
        3. group Id
          BG002
          spread
          0.1768
          value
          1.554
        4. group Id
          BG003
          spread
          0.1757
          value
          1.561
    description
    BSA is the total surface area of the body and was used to calculate the dosage for romidepsin.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area (BSA)
    unit Of Measure
    m2
population Description
Intent to Treat (ITT) includes all participants who received at least one dose of romidepsin.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      40
    4. group Id
      BG003
      value
      50
    units
    Participants
groups
  1. description
    Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
    id
    BG000
    title
    Phase 1: Romidepsin 9mg/m^2
  2. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    BG001
    title
    Phase 1: Romidepsin 14mg/m^2
  3. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    BG002
    title
    Phase 2: Romidepsin 14mg/m^2
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.54
          value
          59.0
        2. group Id
          BG001
          spread
          4.20
          value
          73.6
        3. group Id
          BG002
          spread
          8.43
          value
          68.5
        4. group Id
          BG003
          spread
          8.47
          value
          68.7
    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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          14
      title
      <65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          36
      title
      ≥65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          21
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          29
        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
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          48
      title
      PTCL
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      CTCL
    description
    PTCL is included in a heterogenous group of rare diseases resulting from clonal proliferation of mature thymic lymphocytes. These T-cell tumors account for about 10% to 15% of all lymphoid tumors. CTCL is a non-Hodgkin's lymphoma of helper T-cells that usually presents in the skin. It is classified mainly into mycosis fungoides and Sézary syndrome, and the stage is classified by the Tumor Node Metastasis Blood (TNMB) classification.
    param Type
    NUMBER
    title
    Disease Type by Investigator
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          26
      title
      0 = (Fully Active)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          17
      title
      1 = (Restrictive but ambulatory)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          7
      title
      2 = (Ambulatory but unable to work)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
      title
      3 = (Limited self care)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
      title
      4 = (Completely Disabled)
    description
    Eastern Cooperative Oncology Group (ECOG) performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant 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
    title
    Eastern Cooperative Oncology Group (ECOG)
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.1114
          value
          1.640
        2. group Id
          BG001
          spread
          0.2034
          value
          1.563
        3. group Id
          BG002
          spread
          0.1768
          value
          1.554
        4. group Id
          BG003
          spread
          0.1757
          value
          1.561
    description
    BSA is the total surface area of the body and was used to calculate the dosage for romidepsin.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area (BSA)
    unit Of Measure
    m2
population Description
Intent to Treat (ITT) includes all participants who received at least one dose of romidepsin.

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

Preserved source evidence · Not medical advice