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NCT01985126 · BASELINE

Baseline characteristics

An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD · Source last updated 2018-06-25

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
      18
    2. group Id
      BG001
      value
      106
    3. group Id
      BG002
      value
      124
    units
    Participants
groups
  1. description
    Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
    id
    BG000
    title
    Daratumumab 8 mg/kg
  2. description
    Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
    id
    BG001
    title
    Daratumumab 16 mg/kg
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          66
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          58
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.72
          value
          64.2
        2. group Id
          BG001
          spread
          10
          value
          62.9
        3. group Id
          BG002
          spread
          9.68
          value
          63.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          60
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          64
        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
          0
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          22
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          12
      title
      Spain
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          90
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          28
        title
        I
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          48
        title
        II
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          48
        title
        III
    description
    The International Staging System (ISS) system consists of stage I: beta2-microglobulin less than (\<)3.5 milligram per liter (mg/l) and albumin greater than or equal to (\>=) 3.5 gram (g)/100 ml; stage II: neither stage I nor stage III and stage III: beta2-microglobulin \>= 5.5 mg/l.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage of Disease (ISS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          25
        title
        <= 3 Lines
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          99
        title
        > 3 Lines
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Prior Lines of Therapy
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          116
        title
        Both a PI and IMiD
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        PI only
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        IMiD only
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        None
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Refractory to Proteasome Inhibitor (PI)/ Immunomodulatory Drug (IMiD)
    unit Of Measure
    Participants
population Description
All treated Analysis Set included all participants who received at least 1 dose of daratumumab.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      18
    2. group Id
      BG001
      value
      106
    3. group Id
      BG002
      value
      124
    units
    Participants
groups
  1. description
    Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
    id
    BG000
    title
    Daratumumab 8 mg/kg
  2. description
    Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
    id
    BG001
    title
    Daratumumab 16 mg/kg
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          66
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          58
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.72
          value
          64.2
        2. group Id
          BG001
          spread
          10
          value
          62.9
        3. group Id
          BG002
          spread
          9.68
          value
          63.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          60
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          64
        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
          0
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          22
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          12
      title
      Spain
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          90
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          28
        title
        I
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          48
        title
        II
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          48
        title
        III
    description
    The International Staging System (ISS) system consists of stage I: beta2-microglobulin less than (\<)3.5 milligram per liter (mg/l) and albumin greater than or equal to (\>=) 3.5 gram (g)/100 ml; stage II: neither stage I nor stage III and stage III: beta2-microglobulin \>= 5.5 mg/l.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage of Disease (ISS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          25
        title
        <= 3 Lines
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          99
        title
        > 3 Lines
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Prior Lines of Therapy
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          116
        title
        Both a PI and IMiD
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        PI only
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        IMiD only
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        None
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Refractory to Proteasome Inhibitor (PI)/ Immunomodulatory Drug (IMiD)
    unit Of Measure
    Participants
population Description
All treated Analysis Set included all participants who received at least 1 dose of daratumumab.

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Preserved source evidence · Not medical advice