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NCT03349333 · BASELINE

Baseline characteristics

A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL · Source last updated 2019-10-01

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
      71
    units
    Participants
groups
  1. description
    Vitamin B12 and folic acid will be taken concurrently with pralatrexate pralatrexate: Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle. Vitamin B12 and folic acid: The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator.
    id
    BG000
    title
    PTCL Subtype
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.52
          value
          54.5
      title
      Age(years)
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Customized
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          47
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          71
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          71
      title
      China
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        title
        PTCL not otherwise specified (NOS)
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Angioimmunoblastic T-cell lymphoma
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Anaplastic large cell lymphoma, ALK+
      4. measurements
        1. group Id
          BG000
          value
          7
        title
        Anaplastic large cell lymphoma, ALK-
      5. measurements
        1. group Id
          BG000
          value
          5
        title
        Extranodal NK/T-cell lymphoma - nasal type
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        Subcutaneous panniculitis-like T-cell lymphoma
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Enteropathy-associated T cell lymphoma
      8. measurements
        1. group Id
          BG000
          value
          1
        title
        Adult T-cell lymphoma/leukemia (human T-cell leuke
      9. measurements
        1. group Id
          BG000
          value
          0
        title
        other
      title
      Subtype of PTCL from investigator
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        title
        PTCL not otherwise specified (NOS)
      2. measurements
        1. group Id
          BG000
          value
          20
        title
        Angioimmunoblastic T-cell lymphoma
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Anaplastic large cell lymphoma, ALK+
      4. measurements
        1. group Id
          BG000
          value
          6
        title
        Anaplastic large cell lymphoma, ALK-
      5. measurements
        1. group Id
          BG000
          value
          5
        title
        Extranodal NK/T-cell lymphoma - nasal type
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Subcutaneous panniculitis-like T-cell lymphoma
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Enteropathy-associated T cell lymphoma
      8. measurements
        1. group Id
          BG000
          value
          1
        title
        Adult T-cell lymphoma/leukemia (human T-cell leuke
      9. measurements
        1. group Id
          BG000
          value
          1
        title
        other
      title
      Subtype of PTCL from central review
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline Characteristics
    unit Of Measure
    Participants
population Description
Safety population is 71
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      71
    units
    Participants
groups
  1. description
    Vitamin B12 and folic acid will be taken concurrently with pralatrexate pralatrexate: Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle. Vitamin B12 and folic acid: The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator.
    id
    BG000
    title
    PTCL Subtype
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.52
          value
          54.5
      title
      Age(years)
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Customized
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          47
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          71
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          71
      title
      China
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        title
        PTCL not otherwise specified (NOS)
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Angioimmunoblastic T-cell lymphoma
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Anaplastic large cell lymphoma, ALK+
      4. measurements
        1. group Id
          BG000
          value
          7
        title
        Anaplastic large cell lymphoma, ALK-
      5. measurements
        1. group Id
          BG000
          value
          5
        title
        Extranodal NK/T-cell lymphoma - nasal type
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        Subcutaneous panniculitis-like T-cell lymphoma
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Enteropathy-associated T cell lymphoma
      8. measurements
        1. group Id
          BG000
          value
          1
        title
        Adult T-cell lymphoma/leukemia (human T-cell leuke
      9. measurements
        1. group Id
          BG000
          value
          0
        title
        other
      title
      Subtype of PTCL from investigator
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        title
        PTCL not otherwise specified (NOS)
      2. measurements
        1. group Id
          BG000
          value
          20
        title
        Angioimmunoblastic T-cell lymphoma
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Anaplastic large cell lymphoma, ALK+
      4. measurements
        1. group Id
          BG000
          value
          6
        title
        Anaplastic large cell lymphoma, ALK-
      5. measurements
        1. group Id
          BG000
          value
          5
        title
        Extranodal NK/T-cell lymphoma - nasal type
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Subcutaneous panniculitis-like T-cell lymphoma
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Enteropathy-associated T cell lymphoma
      8. measurements
        1. group Id
          BG000
          value
          1
        title
        Adult T-cell lymphoma/leukemia (human T-cell leuke
      9. measurements
        1. group Id
          BG000
          value
          1
        title
        other
      title
      Subtype of PTCL from central review
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline Characteristics
    unit Of Measure
    Participants
population Description
Safety population is 71

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Preserved source evidence · Not medical advice