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NCT00507416 · BASELINE

Baseline characteristics

Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone · Source last updated 2014-05-01

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
      168
    2. group Id
      BG001
      value
      167
    3. group Id
      BG002
      value
      167
    4. group Id
      BG003
      value
      502
    units
    Participants
groups
  1. description
    Participants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
    id
    BG000
    title
    Bortezomib and Dexamethasone
  2. description
    Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
    id
    BG001
    title
    Bortezomib, Thalidomide, and Dexamethasone
  3. description
    Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
    id
    BG002
    title
    Bortezomib, Melphalan and Prednisone
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.35
          value
          72.6
        2. group Id
          BG001
          spread
          8.73
          value
          71.3
        3. group Id
          BG002
          spread
          8.67
          value
          71.3
        4. group Id
          BG003
          spread
          8.92
          value
          71.7
    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
          140
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          139
        4. group Id
          BG003
          value
          414
      title
      ≥ 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          210
      title
      ≥ 75 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          90
      title
      ≥ 80 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          77
        4. group Id
          BG003
          value
          241
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          90
        4. group Id
          BG003
          value
          261
        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
          131
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          118
        4. group Id
          BG003
          value
          373
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          83
      title
      Black
    3. 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
          2
      title
      Native Hawaiian or Other Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
      title
      American Indian or Alaskan Native
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          35
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          168
        2. group Id
          BG001
          value
          167
        3. group Id
          BG002
          value
          167
        4. group Id
          BG003
          value
          502
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Intention to treat population, defined as all participants randomized
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      168
    2. group Id
      BG001
      value
      167
    3. group Id
      BG002
      value
      167
    4. group Id
      BG003
      value
      502
    units
    Participants
groups
  1. description
    Participants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
    id
    BG000
    title
    Bortezomib and Dexamethasone
  2. description
    Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
    id
    BG001
    title
    Bortezomib, Thalidomide, and Dexamethasone
  3. description
    Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
    id
    BG002
    title
    Bortezomib, Melphalan and Prednisone
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.35
          value
          72.6
        2. group Id
          BG001
          spread
          8.73
          value
          71.3
        3. group Id
          BG002
          spread
          8.67
          value
          71.3
        4. group Id
          BG003
          spread
          8.92
          value
          71.7
    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
          140
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          139
        4. group Id
          BG003
          value
          414
      title
      ≥ 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          210
      title
      ≥ 75 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          90
      title
      ≥ 80 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          77
        4. group Id
          BG003
          value
          241
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          90
        4. group Id
          BG003
          value
          261
        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
          131
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          118
        4. group Id
          BG003
          value
          373
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          83
      title
      Black
    3. 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
          2
      title
      Native Hawaiian or Other Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
      title
      American Indian or Alaskan Native
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          35
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          168
        2. group Id
          BG001
          value
          167
        3. group Id
          BG002
          value
          167
        4. group Id
          BG003
          value
          502
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Intention to treat population, defined as all participants randomized

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Preserved source evidence · Not medical advice