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NCT02841033 · BASELINE

Baseline characteristics

Daratumumab for the Treatment of Patients With AL Amyloidosis · Source last updated 2021-05-07

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
      22
    units
    Participants
groups
  1. description
    Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
    id
    BG000
    title
    Daratumumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          42
          upper Limit
          83
          value
          63
    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
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        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
          16
      title
      White Non-Hispanic
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Hispanic or Latino
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          8
          upper Limit
          184
          value
          48
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time since initial diagnosis
    unit Of Measure
    months
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          7
          value
          2
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior therapies
    unit Of Measure
    lines of treatment
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          180
          value
          9
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time since last plasma cell-directed treatment
    unit Of Measure
    months
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2.9
          upper Limit
          854
          value
          80.7
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    dFLC
    unit Of Measure
    mg/L
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          5
          value
          2
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Number of organ systems involved
    unit Of Measure
    organ systems
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
    description
    The NYHA \[New York Heart Association} classification of heart failure uses categories I, II, III, and IV for patients' symptoms. The higher the Class, the more symptoms of heart failure that the patient has. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    NYHA Class II or III
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      22
    units
    Participants
groups
  1. description
    Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
    id
    BG000
    title
    Daratumumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          42
          upper Limit
          83
          value
          63
    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
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        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
          16
      title
      White Non-Hispanic
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Hispanic or Latino
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          8
          upper Limit
          184
          value
          48
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time since initial diagnosis
    unit Of Measure
    months
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          7
          value
          2
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior therapies
    unit Of Measure
    lines of treatment
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          180
          value
          9
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time since last plasma cell-directed treatment
    unit Of Measure
    months
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2.9
          upper Limit
          854
          value
          80.7
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    dFLC
    unit Of Measure
    mg/L
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          5
          value
          2
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Number of organ systems involved
    unit Of Measure
    organ systems
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
    description
    The NYHA \[New York Heart Association} classification of heart failure uses categories I, II, III, and IV for patients' symptoms. The higher the Class, the more symptoms of heart failure that the patient has. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    NYHA Class II or III
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice