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NCT04504825 · BASELINE

Baseline characteristics

A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES) · Source last updated 2026-07-02

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
      84
    2. group Id
      BG001
      value
      41
    3. group Id
      BG002
      value
      125
    units
    Participants
groups
  1. description
    During the PETP, participants were administered CAEL-101 as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
    id
    BG000
    title
    CAEL-101 + Plasma Cell Dyscrasia Treatment
  2. description
    During the PETP, participants were administered placebo as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
    id
    BG001
    title
    Placebo + Plasma Cell Dyscrasia Treatment
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.93
          value
          65.5
        2. group Id
          BG001
          spread
          10.09
          value
          69.7
        3. group Id
          BG002
          spread
          10.80
          value
          66.9
      denoms
      1. counts
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          125
        units
        Participants
      title
      Overall (All Randomized Participants)
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.75
          value
          64.7
        2. group Id
          BG001
          spread
          5.91
          value
          76.8
        3. group Id
          BG002
          spread
          11.04
          value
          67.1
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          31
        units
        Participants
      title
      Kappa FLC Subtype
    3. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.26
          value
          65.7
        2. group Id
          BG001
          spread
          10.33
          value
          68.6
        3. group Id
          BG002
          spread
          10.95
          value
          66.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          91
        units
        Participants
      title
      Lambda FLC Subtype
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Data reported for Overall participants and for 2 FLC subtypes (Kappa and Lambda).
    title
    Age, Customized
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          51
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          74
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          125
        units
        Participants
      title
      Overall (All Randomized Participants)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          22
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          31
        units
        Participants
      title
      Kappa FLC Subtype
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          41
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          50
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          91
        units
        Participants
      title
      Lambda FLC Subtype
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Data reported for Overall participants and for 2 FLC subtypes (Kappa and Lambda).
    title
    Sex/Gender, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          114
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Unknown
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          125
        units
        Participants
      title
      Overall (All Randomized Participants)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          29
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          31
        units
        Participants
      title
      FLC Subtype Kappa
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          82
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Unknown
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          91
        units
        Participants
      title
      FLC Subtype Lambda
    description
    Ethnicity Baseline Characteristic
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Data reported for Overall participants and for 2 FLC subtypes (Kappa and Lambda).
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          14
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          86
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          20
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          125
        units
        Participants
      title
      Overall (All Randomized Participants)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          22
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          31
        units
        Participants
      title
      FLC Subtype Kappa
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          61
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          91
        units
        Participants
      title
      FLC Subtype Lambda
    description
    Race Baseline Characteristic
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Data reported for Overall participants and for 2 FLC subtypes (Kappa and Lambda).
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent-to-treat Set: all participants who were randomized, presented as 'Overall (All Randomized Participants)' and 2 subgroups, 'Kappa FLC Subtype' and 'Lambda FLC Subtype'.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      84
    2. group Id
      BG001
      value
      41
    3. group Id
      BG002
      value
      125
    units
    Participants
groups
  1. description
    During the PETP, participants were administered CAEL-101 as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
    id
    BG000
    title
    CAEL-101 + Plasma Cell Dyscrasia Treatment
  2. description
    During the PETP, participants were administered placebo as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
    id
    BG001
    title
    Placebo + Plasma Cell Dyscrasia Treatment
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.93
          value
          65.5
        2. group Id
          BG001
          spread
          10.09
          value
          69.7
        3. group Id
          BG002
          spread
          10.80
          value
          66.9
      denoms
      1. counts
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          125
        units
        Participants
      title
      Overall (All Randomized Participants)
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.75
          value
          64.7
        2. group Id
          BG001
          spread
          5.91
          value
          76.8
        3. group Id
          BG002
          spread
          11.04
          value
          67.1
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          31
        units
        Participants
      title
      Kappa FLC Subtype
    3. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.26
          value
          65.7
        2. group Id
          BG001
          spread
          10.33
          value
          68.6
        3. group Id
          BG002
          spread
          10.95
          value
          66.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          91
        units
        Participants
      title
      Lambda FLC Subtype
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Data reported for Overall participants and for 2 FLC subtypes (Kappa and Lambda).
    title
    Age, Customized
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          51
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          74
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          125
        units
        Participants
      title
      Overall (All Randomized Participants)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          22
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          31
        units
        Participants
      title
      Kappa FLC Subtype
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          41
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          50
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          91
        units
        Participants
      title
      Lambda FLC Subtype
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Data reported for Overall participants and for 2 FLC subtypes (Kappa and Lambda).
    title
    Sex/Gender, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          114
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Unknown
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          125
        units
        Participants
      title
      Overall (All Randomized Participants)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          29
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          31
        units
        Participants
      title
      FLC Subtype Kappa
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          82
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Unknown
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          91
        units
        Participants
      title
      FLC Subtype Lambda
    description
    Ethnicity Baseline Characteristic
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Data reported for Overall participants and for 2 FLC subtypes (Kappa and Lambda).
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          14
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          86
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          20
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          125
        units
        Participants
      title
      Overall (All Randomized Participants)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          22
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          31
        units
        Participants
      title
      FLC Subtype Kappa
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          61
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          91
        units
        Participants
      title
      FLC Subtype Lambda
    description
    Race Baseline Characteristic
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Data reported for Overall participants and for 2 FLC subtypes (Kappa and Lambda).
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent-to-treat Set: all participants who were randomized, presented as 'Overall (All Randomized Participants)' and 2 subgroups, 'Kappa FLC Subtype' and 'Lambda FLC Subtype'.

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