Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01193842 · BASELINE

Baseline characteristics

Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas · Source last updated 2023-11-21

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
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      45
    5. group Id
      BG004
      value
      45
    6. group Id
      BG005
      value
      103
    units
    Participants
groups
  1. description
    Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
    id
    BG000
    title
    Phase I: VR-DA-EPOCH, Dose Level 1
  2. description
    Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
    id
    BG001
    title
    Phase I: VR-DA-EPOCH, Dose Level 2
  3. description
    Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
    id
    BG002
    title
    Phase I: VR-CHOP, Dose Level 1
  4. description
    Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
    id
    BG003
    title
    Phase II, V+DA-EPOCH
  5. description
    Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
    id
    BG004
    title
    Phase II, DA-R-EPOCH
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.4
          value
          45.7
        2. group Id
          BG001
          spread
          10.1
          value
          50.4
        3. group Id
          BG002
          spread
          0
          value
          59.5
        4. group Id
          BG003
          spread
          10.1
          value
          49.2
        5. group Id
          BG004
          spread
          9.2
          value
          45
        6. group Id
          BG005
          spread
          9.8
          value
          47.2
    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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          39
        5. group Id
          BG004
          value
          45
        6. group Id
          BG005
          value
          96
        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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          29
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          29
        5. group Id
          BG004
          value
          30
        6. group Id
          BG005
          value
          70
        title
        Not Hispanic or Latino
      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
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. 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
          1
        6. group Id
          BG005
          value
          1
        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
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          22
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          31
        6. group Id
          BG005
          value
          65
        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
        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
          8
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          12
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          45
        6. group Id
          BG005
          value
          103
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Eligible participants completing at least one cycle of treatment; 3 ineligible participants and 1 participant not completing one cycle of Phase I treatment were not included.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      45
    5. group Id
      BG004
      value
      45
    6. group Id
      BG005
      value
      103
    units
    Participants
groups
  1. description
    Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
    id
    BG000
    title
    Phase I: VR-DA-EPOCH, Dose Level 1
  2. description
    Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
    id
    BG001
    title
    Phase I: VR-DA-EPOCH, Dose Level 2
  3. description
    Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
    id
    BG002
    title
    Phase I: VR-CHOP, Dose Level 1
  4. description
    Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
    id
    BG003
    title
    Phase II, V+DA-EPOCH
  5. description
    Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
    id
    BG004
    title
    Phase II, DA-R-EPOCH
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.4
          value
          45.7
        2. group Id
          BG001
          spread
          10.1
          value
          50.4
        3. group Id
          BG002
          spread
          0
          value
          59.5
        4. group Id
          BG003
          spread
          10.1
          value
          49.2
        5. group Id
          BG004
          spread
          9.2
          value
          45
        6. group Id
          BG005
          spread
          9.8
          value
          47.2
    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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          39
        5. group Id
          BG004
          value
          45
        6. group Id
          BG005
          value
          96
        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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          29
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          29
        5. group Id
          BG004
          value
          30
        6. group Id
          BG005
          value
          70
        title
        Not Hispanic or Latino
      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
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. 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
          1
        6. group Id
          BG005
          value
          1
        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
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          22
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          31
        6. group Id
          BG005
          value
          65
        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
        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
          8
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          12
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          45
        6. group Id
          BG005
          value
          103
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Eligible participants completing at least one cycle of treatment; 3 ineligible participants and 1 participant not completing one cycle of Phase I treatment were not included.

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

Preserved source evidence · Not medical advice