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NCT00936611 · BASELINE

Baseline characteristics

LBH589 in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia · Source last updated 2021-01-28

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
      36
    units
    Participants
groups
  1. description
    30 mg three days a week (Mondays, Wednesdays and Fridays). 1 cycle was 28 days Dose modifications for attributable toxicities allowed for reduction to: * 25 mg, 20 mg three times a week every week * Or 20 mg three times a week every other week. No dose re-escalation was allowed. * The protocol was amended on 6/15/2010 because of concerns of toxicity to allow a starting dose of 25 mg; 12/36 (33%) patients were enrolled on the 25 mg dose. LBH589
    id
    BG000
    title
    LBH589
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          47
          upper Limit
          80
          value
          61.6
    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
          22
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          35
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          804
          upper Limit
          10300
          value
          3240
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median IgM
    unit Of Measure
    mg/dL
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.63
          upper Limit
          5.1
          value
          2.06
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median M Spike
    unit Of Measure
    gm/dL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          74
          upper Limit
          388
          value
          242
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median Platelets
    unit Of Measure
    platelets x 10^3 / mL
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          8.2
          upper Limit
          14.5
          value
          10.7
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median Hemoglobin
    unit Of Measure
    gm/dL
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.4
          upper Limit
          7.4
          value
          3.3
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median Beta 2 Microglobulin
    unit Of Measure
    mg/dL
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          5
          upper Limit
          100
          value
          70
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Percentage of Bone Marrow Involvement
    unit Of Measure
    percentage of marrow
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        title
        Present
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        Absent
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Lymph Nodes and Hepatocyte Selection Medium Assessment by CT Scan Evidence of Disease
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        High
      2. measurements
        1. group Id
          BG000
          value
          14
        title
        Intermediate
      3. measurements
        1. group Id
          BG000
          value
          15
        title
        Low
    description
    Measure Description: Low is defined as 1 or dewer of the following: Hemoglobin (HB) \<=11.5 g/dL Platelet (PT) \<=100 x 10\^9 / L Beta 2 Microglubin (B2M) \> 3 mg/L Immunoglobulin M (IgM) \> 7 g/dL Intermediate is defined as over 65 years old or two of the following: HB \<=11.5 g/dL PT \<=100 x 10\^9 / L B2M \> 3 mg/L IgM\> 7 g/dL High is defined as more than 2 of the following: Over 65 years old HB \<=11.5 g/dL PT \<=100 x 10\^9 / L B2M \> 3 mg/L IgM\> 7 g/dL
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Prognostic Scoring System for Waldenstrom Macroglobulinemia
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      36
    units
    Participants
groups
  1. description
    30 mg three days a week (Mondays, Wednesdays and Fridays). 1 cycle was 28 days Dose modifications for attributable toxicities allowed for reduction to: * 25 mg, 20 mg three times a week every week * Or 20 mg three times a week every other week. No dose re-escalation was allowed. * The protocol was amended on 6/15/2010 because of concerns of toxicity to allow a starting dose of 25 mg; 12/36 (33%) patients were enrolled on the 25 mg dose. LBH589
    id
    BG000
    title
    LBH589
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          47
          upper Limit
          80
          value
          61.6
    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
          22
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          35
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          804
          upper Limit
          10300
          value
          3240
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median IgM
    unit Of Measure
    mg/dL
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.63
          upper Limit
          5.1
          value
          2.06
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median M Spike
    unit Of Measure
    gm/dL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          74
          upper Limit
          388
          value
          242
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median Platelets
    unit Of Measure
    platelets x 10^3 / mL
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          8.2
          upper Limit
          14.5
          value
          10.7
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median Hemoglobin
    unit Of Measure
    gm/dL
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.4
          upper Limit
          7.4
          value
          3.3
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median Beta 2 Microglobulin
    unit Of Measure
    mg/dL
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          5
          upper Limit
          100
          value
          70
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Percentage of Bone Marrow Involvement
    unit Of Measure
    percentage of marrow
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        title
        Present
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        Absent
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Lymph Nodes and Hepatocyte Selection Medium Assessment by CT Scan Evidence of Disease
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        High
      2. measurements
        1. group Id
          BG000
          value
          14
        title
        Intermediate
      3. measurements
        1. group Id
          BG000
          value
          15
        title
        Low
    description
    Measure Description: Low is defined as 1 or dewer of the following: Hemoglobin (HB) \<=11.5 g/dL Platelet (PT) \<=100 x 10\^9 / L Beta 2 Microglubin (B2M) \> 3 mg/L Immunoglobulin M (IgM) \> 7 g/dL Intermediate is defined as over 65 years old or two of the following: HB \<=11.5 g/dL PT \<=100 x 10\^9 / L B2M \> 3 mg/L IgM\> 7 g/dL High is defined as more than 2 of the following: Over 65 years old HB \<=11.5 g/dL PT \<=100 x 10\^9 / L B2M \> 3 mg/L IgM\> 7 g/dL
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Prognostic Scoring System for Waldenstrom Macroglobulinemia
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice