Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04703192 · BASELINE

Baseline characteristics

Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01) · Source last updated 2026-07-20

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
      133
    2. group Id
      BG001
      value
      22
    3. group Id
      BG002
      value
      155
    units
    Participants
groups
  1. description
    Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible peripheral T-cell lymphoma .
    id
    BG000
    title
    Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
  2. description
    Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible adult T-cell leukemia/lymphoma.
    id
    BG001
    title
    Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. 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
          53
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          63
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          92
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.51
          value
          65.6
        2. group Id
          BG001
          spread
          13.11
          value
          62.6
        3. group Id
          BG002
          spread
          12.60
          value
          65.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          49
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          106
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          42
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          16
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          81
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The Safety Analysis Set included all subjects who received at least 1 dose of study drug. Subjects were analyzed for each cohort.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      133
    2. group Id
      BG001
      value
      22
    3. group Id
      BG002
      value
      155
    units
    Participants
groups
  1. description
    Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible peripheral T-cell lymphoma .
    id
    BG000
    title
    Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
  2. description
    Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible adult T-cell leukemia/lymphoma.
    id
    BG001
    title
    Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. 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
          53
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          63
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          92
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.51
          value
          65.6
        2. group Id
          BG001
          spread
          13.11
          value
          62.6
        3. group Id
          BG002
          spread
          12.60
          value
          65.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          49
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          106
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          42
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          16
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          81
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The Safety Analysis Set included all subjects who received at least 1 dose of study drug. Subjects were analyzed for each cohort.

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

Preserved source evidence · Not medical advice