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NCT02567656 · BASELINE

Baseline characteristics

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma · Source last updated 2020-01-13

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
      4
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      5
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      19
    6. group Id
      BG005
      value
      20
    7. group Id
      BG006
      value
      58
    units
    Participants
groups
  1. description
    RP6530 administered 200 mg orally twice a day.
    id
    BG000
    title
    Dose escalation_Cohort 1_200 mg
  2. description
    RP6530 administered 400 mg orally twice a day.
    id
    BG001
    title
    Dose escalation_Cohort 2_400 mg
  3. description
    RP6530 administered 800 mg orally twice a day under fasting condition
    id
    BG002
    title
    Dose escalation_Cohort 3_800 mg (Fasting)
  4. description
    RP6530 administered 800 mg orally twice a day under fed condition
    id
    BG003
    title
    Dose escalation_Cohort 4_800 mg (Fed)
  5. description
    RP6530 administered 800 mg orally twice a day under fasting condition
    id
    BG004
    title
    Dose expansion_PTCL_800 mg (Fasting)
  6. description
    RP6530 administered 800 mg orally twice a day under fasting condition
    id
    BG005
    title
    Dose expansion_CTCL_800 mg (Fasting)
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          47.75
          upper Limit
          76.58
          value
          63.45
        2. group Id
          BG001
          lower Limit
          51.96
          upper Limit
          76.11
          value
          65.03
        3. group Id
          BG002
          lower Limit
          52.11
          upper Limit
          70.58
          value
          67.89
        4. group Id
          BG003
          lower Limit
          40.92
          upper Limit
          73.24
          value
          65.86
        5. group Id
          BG004
          lower Limit
          53.72
          upper Limit
          89.55
          value
          63.95
        6. group Id
          BG005
          lower Limit
          39.45
          upper Limit
          84.55
          value
          67.07
        7. group Id
          BG006
          lower Limit
          39.45
          upper Limit
          89.55
          value
          67.07
    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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          28
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          30
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        American Indian or Alaska Native
      2. 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
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        title
        Asian
      3. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. 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
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          49
        title
        White
      6. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        More than one race
      7. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          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
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          20
        7. group Id
          BG006
          value
          58
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      5
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      19
    6. group Id
      BG005
      value
      20
    7. group Id
      BG006
      value
      58
    units
    Participants
groups
  1. description
    RP6530 administered 200 mg orally twice a day.
    id
    BG000
    title
    Dose escalation_Cohort 1_200 mg
  2. description
    RP6530 administered 400 mg orally twice a day.
    id
    BG001
    title
    Dose escalation_Cohort 2_400 mg
  3. description
    RP6530 administered 800 mg orally twice a day under fasting condition
    id
    BG002
    title
    Dose escalation_Cohort 3_800 mg (Fasting)
  4. description
    RP6530 administered 800 mg orally twice a day under fed condition
    id
    BG003
    title
    Dose escalation_Cohort 4_800 mg (Fed)
  5. description
    RP6530 administered 800 mg orally twice a day under fasting condition
    id
    BG004
    title
    Dose expansion_PTCL_800 mg (Fasting)
  6. description
    RP6530 administered 800 mg orally twice a day under fasting condition
    id
    BG005
    title
    Dose expansion_CTCL_800 mg (Fasting)
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          47.75
          upper Limit
          76.58
          value
          63.45
        2. group Id
          BG001
          lower Limit
          51.96
          upper Limit
          76.11
          value
          65.03
        3. group Id
          BG002
          lower Limit
          52.11
          upper Limit
          70.58
          value
          67.89
        4. group Id
          BG003
          lower Limit
          40.92
          upper Limit
          73.24
          value
          65.86
        5. group Id
          BG004
          lower Limit
          53.72
          upper Limit
          89.55
          value
          63.95
        6. group Id
          BG005
          lower Limit
          39.45
          upper Limit
          84.55
          value
          67.07
        7. group Id
          BG006
          lower Limit
          39.45
          upper Limit
          89.55
          value
          67.07
    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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          28
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          30
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        American Indian or Alaska Native
      2. 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
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        title
        Asian
      3. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. 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
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          49
        title
        White
      6. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        More than one race
      7. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          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
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          20
        7. group Id
          BG006
          value
          58
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice