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NCT02092909 · BASELINE

Baseline characteristics

Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia · Source last updated 2019-09-10

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
      6
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      14
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      31
    units
    Participants
groups
  1. description
    IMO-8400 0.6 mg/kg once weekly s.c.
    id
    BG000
    title
    IMO-8400 0.6 mg/kg 1x/wk
  2. description
    IMO-8400 1.2 mg/kg once weekly s.c.
    id
    BG001
    title
    IMO-8400 1.2 mg/kg 1x/wk
  3. description
    IMO-8400 1.2 mg/kg twice weekly s.c.
    id
    BG002
    title
    IMO-8400 1.2 mg/kg 2x/wk
  4. description
    IMO-8400 2.4 mg/kg once weekly s.c.
    id
    BG003
    title
    IMO-8400 2.4 mg/kg 1x/wk
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.92
          value
          74.8
        2. group Id
          BG001
          spread
          9.71
          value
          70.4
        3. group Id
          BG002
          spread
          11.17
          value
          66.5
        4. group Id
          BG003
          spread
          11.36
          value
          62.7
        5. group Id
          BG004
          spread
          11.53
          value
          68.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
    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
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          22
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          28
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.62
          value
          7.03
        2. group Id
          BG001
          spread
          6.90
          value
          10.16
        3. group Id
          BG002
          spread
          3.55
          value
          7.66
        4. group Id
          BG003
          spread
          5.22
          value
          5.78
        5. group Id
          BG004
          spread
          4.66
          value
          7.58
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time Since WM Diagnosis (yrs)
    unit Of Measure
    years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          10
        title
        Low
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          18
        title
        Intermediate
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        title
        High
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline IPSSWM Score
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. comment
          N=1
          group Id
          BG000
          spread
          NA
          value
          1090
        2. group Id
          BG001
          spread
          973
          value
          2410
        3. group Id
          BG002
          spread
          1567
          value
          2857
        4. group Id
          BG003
          spread
          1727
          value
          2910
        5. group Id
          BG004
          spread
          1473
          value
          2715
      denoms
      1. counts
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          26
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Total IgM was not collected in the original protocol version, and only added after a protocol amendment.
    title
    Baseline Total IgM
    unit Of Measure
    mg/dL
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.640
          value
          1.04
        2. group Id
          BG001
          spread
          0.614
          value
          0.93
        3. group Id
          BG002
          spread
          0.835
          value
          1.57
        4. group Id
          BG003
          spread
          0.741
          value
          1.62
        5. group Id
          BG004
          spread
          0.773
          value
          1.37
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Monoclonal IgM
    unit Of Measure
    g/dL
population Description
Safety Population
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      14
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      31
    units
    Participants
groups
  1. description
    IMO-8400 0.6 mg/kg once weekly s.c.
    id
    BG000
    title
    IMO-8400 0.6 mg/kg 1x/wk
  2. description
    IMO-8400 1.2 mg/kg once weekly s.c.
    id
    BG001
    title
    IMO-8400 1.2 mg/kg 1x/wk
  3. description
    IMO-8400 1.2 mg/kg twice weekly s.c.
    id
    BG002
    title
    IMO-8400 1.2 mg/kg 2x/wk
  4. description
    IMO-8400 2.4 mg/kg once weekly s.c.
    id
    BG003
    title
    IMO-8400 2.4 mg/kg 1x/wk
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.92
          value
          74.8
        2. group Id
          BG001
          spread
          9.71
          value
          70.4
        3. group Id
          BG002
          spread
          11.17
          value
          66.5
        4. group Id
          BG003
          spread
          11.36
          value
          62.7
        5. group Id
          BG004
          spread
          11.53
          value
          68.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
    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
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          22
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          28
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.62
          value
          7.03
        2. group Id
          BG001
          spread
          6.90
          value
          10.16
        3. group Id
          BG002
          spread
          3.55
          value
          7.66
        4. group Id
          BG003
          spread
          5.22
          value
          5.78
        5. group Id
          BG004
          spread
          4.66
          value
          7.58
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time Since WM Diagnosis (yrs)
    unit Of Measure
    years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          10
        title
        Low
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          18
        title
        Intermediate
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        title
        High
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline IPSSWM Score
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. comment
          N=1
          group Id
          BG000
          spread
          NA
          value
          1090
        2. group Id
          BG001
          spread
          973
          value
          2410
        3. group Id
          BG002
          spread
          1567
          value
          2857
        4. group Id
          BG003
          spread
          1727
          value
          2910
        5. group Id
          BG004
          spread
          1473
          value
          2715
      denoms
      1. counts
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          26
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Total IgM was not collected in the original protocol version, and only added after a protocol amendment.
    title
    Baseline Total IgM
    unit Of Measure
    mg/dL
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.640
          value
          1.04
        2. group Id
          BG001
          spread
          0.614
          value
          0.93
        3. group Id
          BG002
          spread
          0.835
          value
          1.57
        4. group Id
          BG003
          spread
          0.741
          value
          1.62
        5. group Id
          BG004
          spread
          0.773
          value
          1.37
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Monoclonal IgM
    unit Of Measure
    g/dL
population Description
Safety Population

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Preserved source evidence · Not medical advice