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NCT02312206 · BASELINE

Baseline characteristics

The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis · Source last updated 2023-11-14

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
      130
    2. group Id
      BG001
      value
      130
    3. group Id
      BG002
      value
      260
    units
    Participants
groups
  1. description
    NEOD001, 24 mg/kg IV every 4 weeks on top of Standard of Care
    id
    BG000
    title
    NEOD001 (24 mg/kg) + Standard of Care
  2. description
    Placebo 0.9% Saline IV every 4 weeks on top of Standard of Care
    id
    BG001
    title
    Placebo + Standard of Care
  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
          69
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          139
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          121
        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
          9.478
          value
          63.69
        2. group Id
          BG001
          spread
          9.708
          value
          63.24
        3. group Id
          BG002
          spread
          9.578
          value
          63.46
    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
          48
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          88
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          172
        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
          118
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          238
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          12
      title
      Black Or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
      title
      Race not Reported
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Hispanic Or Latino
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          116
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          238
      title
      Not Hispanic Or Latino
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
      title
      Ethnicity Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Overall Number of Baseline Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      130
    2. group Id
      BG001
      value
      130
    3. group Id
      BG002
      value
      260
    units
    Participants
groups
  1. description
    NEOD001, 24 mg/kg IV every 4 weeks on top of Standard of Care
    id
    BG000
    title
    NEOD001 (24 mg/kg) + Standard of Care
  2. description
    Placebo 0.9% Saline IV every 4 weeks on top of Standard of Care
    id
    BG001
    title
    Placebo + Standard of Care
  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
          69
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          139
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          121
        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
          9.478
          value
          63.69
        2. group Id
          BG001
          spread
          9.708
          value
          63.24
        3. group Id
          BG002
          spread
          9.578
          value
          63.46
    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
          48
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          88
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          172
        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
          118
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          238
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          12
      title
      Black Or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
      title
      Race not Reported
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Hispanic Or Latino
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          116
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          238
      title
      Not Hispanic Or Latino
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
      title
      Ethnicity Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Overall Number of Baseline Participants

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Preserved source evidence · Not medical advice