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NCT02654990 · BASELINE

Baseline characteristics

Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma · Source last updated 2024-07-12

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
      82
    2. group Id
      BG001
      value
      83
    3. group Id
      BG002
      value
      83
    4. group Id
      BG003
      value
      248
    units
    Participants
groups
  1. description
    Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    BG000
    title
    Arm A - Panobinostat (20 mg, TIW)
  2. description
    Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    BG001
    title
    Arm B - Panobinostat (20 mg, BIW)
  3. description
    Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    BG002
    title
    Arm C - Panobinostat (10 mg, TIW)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          45
          upper Limit
          83
          value
          67.0
        2. group Id
          BG001
          lower Limit
          47
          upper Limit
          87
          value
          65.0
        3. group Id
          BG002
          lower Limit
          33
          upper Limit
          84
          value
          66.0
        4. group Id
          BG003
          lower Limit
          33
          upper Limit
          87
          value
          66.5
    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
          40
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          112
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          50
        4. group Id
          BG003
          value
          136
        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
          49
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          130
        title
        Not Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          14
        title
        Southeast Asian
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          18
        title
        Hispanic or Latino
      4. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          66
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          20
        title
        Unknown/Not Reported
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          213
        title
        Caucasian
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          23
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
        title
        Other
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          118
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          116
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          14
        title
        2
      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
        title
        3
      5. 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
        title
        4
    description
    Scale to assess disease progression and disease effects on daily living abilities, as well as determine appropriate treatment and prognosis. Status range includes: 0 (fully active); 1 (restricted physical activity); 2 (unable to carry out work activities); 3 (limited self-care); 4 (completely disabled).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    Participants
population Description
Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      82
    2. group Id
      BG001
      value
      83
    3. group Id
      BG002
      value
      83
    4. group Id
      BG003
      value
      248
    units
    Participants
groups
  1. description
    Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    BG000
    title
    Arm A - Panobinostat (20 mg, TIW)
  2. description
    Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    BG001
    title
    Arm B - Panobinostat (20 mg, BIW)
  3. description
    Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    BG002
    title
    Arm C - Panobinostat (10 mg, TIW)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          45
          upper Limit
          83
          value
          67.0
        2. group Id
          BG001
          lower Limit
          47
          upper Limit
          87
          value
          65.0
        3. group Id
          BG002
          lower Limit
          33
          upper Limit
          84
          value
          66.0
        4. group Id
          BG003
          lower Limit
          33
          upper Limit
          87
          value
          66.5
    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
          40
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          112
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          50
        4. group Id
          BG003
          value
          136
        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
          49
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          130
        title
        Not Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          14
        title
        Southeast Asian
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          18
        title
        Hispanic or Latino
      4. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          66
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          20
        title
        Unknown/Not Reported
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          213
        title
        Caucasian
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          23
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
        title
        Other
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          118
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          116
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          14
        title
        2
      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
        title
        3
      5. 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
        title
        4
    description
    Scale to assess disease progression and disease effects on daily living abilities, as well as determine appropriate treatment and prognosis. Status range includes: 0 (fully active); 1 (restricted physical activity); 2 (unable to carry out work activities); 3 (limited self-care); 4 (completely disabled).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    Participants
population Description
Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.

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Preserved source evidence · Not medical advice