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NCT02181738 · BASELINE

Baseline characteristics

Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational) · Source last updated 2023-11-28

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
      63
    2. group Id
      BG001
      value
      80
    3. group Id
      BG002
      value
      100
    4. group Id
      BG003
      value
      51
    5. group Id
      BG004
      value
      294
    units
    Participants
groups
  1. description
    Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
    id
    BG000
    title
    Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
  2. description
    Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
    id
    BG001
    title
    Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
  3. description
    Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
    id
    BG002
    title
    Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
  4. description
    Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
    id
    BG003
    title
    Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.54
          value
          36.3
        2. group Id
          BG001
          spread
          13.00
          value
          38.7
        3. group Id
          BG002
          spread
          12.41
          value
          36.1
        4. group Id
          BG003
          spread
          16.88
          value
          39.0
        5. group Id
          BG004
          spread
          13.47
          value
          37.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    All treated participants
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          121
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          56
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          173
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All treated participants
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          56
        4. group Id
          BG003
          value
          40
        5. group Id
          BG004
          value
          189
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          100
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All treated participants
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          86
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          256
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          14
      title
      Black or African
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          11
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
      title
      American Indian or Alaska Native
    5. 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
      title
      Native Hawaiian or Other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          11
      title
      Other
    param Type
    NUMBER
    population Description
    All treated particpants
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      63
    2. group Id
      BG001
      value
      80
    3. group Id
      BG002
      value
      100
    4. group Id
      BG003
      value
      51
    5. group Id
      BG004
      value
      294
    units
    Participants
groups
  1. description
    Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
    id
    BG000
    title
    Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
  2. description
    Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
    id
    BG001
    title
    Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
  3. description
    Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
    id
    BG002
    title
    Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
  4. description
    Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
    id
    BG003
    title
    Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.54
          value
          36.3
        2. group Id
          BG001
          spread
          13.00
          value
          38.7
        3. group Id
          BG002
          spread
          12.41
          value
          36.1
        4. group Id
          BG003
          spread
          16.88
          value
          39.0
        5. group Id
          BG004
          spread
          13.47
          value
          37.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    All treated participants
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          121
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          56
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          173
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All treated participants
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          56
        4. group Id
          BG003
          value
          40
        5. group Id
          BG004
          value
          189
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          100
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    All treated participants
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          86
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          256
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          14
      title
      Black or African
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          11
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
      title
      American Indian or Alaska Native
    5. 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
      title
      Native Hawaiian or Other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          11
      title
      Other
    param Type
    NUMBER
    population Description
    All treated particpants
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice