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NCT02653976 · BASELINE

Baseline characteristics

A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) · Source last updated 2024-01-26

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
      65
    units
    Participants
groups
  1. description
    SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
    id
    BG000
    title
    SP-02L (Darinaparsin for Injection)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          28
          upper Limit
          85
          value
          68.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          45
        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
          65
        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. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          37
      title
      Japan
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      South Korea
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Taiwan
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Hong Kong
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        title
        Peripheral T-cell lymphoma not otherwise specified
      2. measurements
        1. group Id
          BG000
          value
          17
        title
        Angioimmunoblastic T-cell Lymphoma
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        Anaplastic large cell lymphoma, ALK-negative
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Anaplastic large cell lymphoma, ALK-positive
      5. measurements
        1. group Id
          BG000
          value
          2
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histopathological Diagnosis
    unit Of Measure
    Participants
population Description
Safety analysis set included all patients who received at least one dose of SP-02L (darinaparsin for injection).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      65
    units
    Participants
groups
  1. description
    SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
    id
    BG000
    title
    SP-02L (Darinaparsin for Injection)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          28
          upper Limit
          85
          value
          68.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          45
        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
          65
        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. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          37
      title
      Japan
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      South Korea
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Taiwan
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Hong Kong
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        title
        Peripheral T-cell lymphoma not otherwise specified
      2. measurements
        1. group Id
          BG000
          value
          17
        title
        Angioimmunoblastic T-cell Lymphoma
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        Anaplastic large cell lymphoma, ALK-negative
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Anaplastic large cell lymphoma, ALK-positive
      5. measurements
        1. group Id
          BG000
          value
          2
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histopathological Diagnosis
    unit Of Measure
    Participants
population Description
Safety analysis set included all patients who received at least one dose of SP-02L (darinaparsin for injection).

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Preserved source evidence · Not medical advice