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NCT01324947 · BASELINE

Baseline characteristics

Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory Multiple Myeloma · Source last updated 2019-11-19

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
      74
    units
    Participants
groups
  1. description
    Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
    id
    BG000
    title
    Pomalidomide
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.25
          value
          64.9
    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
          32
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          42
        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. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Native Hawaiian or Other Pacific Islanders
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          52
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Not Collected
    param Type
    NUMBER
    title
    Race
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          49
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Not Collected
    param Type
    NUMBER
    title
    Ethnicity
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
    param Type
    NUMBER
    title
    Participants with Prior Anti-Myeloma (MM) Therapies
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          50
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Missing
    description
    Stages are: Stage I: Hemoglobulin \> 10 g/dL; serum calcium normal on roentgenogram; normal bone structure or solitary bone plasmacytoma only; Low M-component production rates (IgG value \< 5 g/dL, IgA value \< 3 g/dL; Bence Jones protein \< 4 g/24h) Stage II: Overall data as minimally abnormal for stage I, and no single value as abnormal as defined for stage III Stage III: 1 or more of below: Hemoglobin \< 8.5 g/dL; serum calcium \> 12 mg/dL; Advanced lytic bone lesions (scale 3); High-M-component production rates (IgG value \> 7 g/dL, IgA value \> 5 g/dL; Bence Jones protein \> 12 g/24h)
    param Type
    NUMBER
    title
    Durie-Salmon Multiple Myeloma Stage before Study Entry
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.72
          value
          7.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time From First Pathologic Diagnosis
    unit Of Measure
    years
population Description
The intent-to-treat (ITT) population was defined as all enrolled participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      74
    units
    Participants
groups
  1. description
    Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
    id
    BG000
    title
    Pomalidomide
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.25
          value
          64.9
    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
          32
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          42
        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. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Native Hawaiian or Other Pacific Islanders
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          52
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Not Collected
    param Type
    NUMBER
    title
    Race
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          49
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Not Collected
    param Type
    NUMBER
    title
    Ethnicity
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
    param Type
    NUMBER
    title
    Participants with Prior Anti-Myeloma (MM) Therapies
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          50
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Missing
    description
    Stages are: Stage I: Hemoglobulin \> 10 g/dL; serum calcium normal on roentgenogram; normal bone structure or solitary bone plasmacytoma only; Low M-component production rates (IgG value \< 5 g/dL, IgA value \< 3 g/dL; Bence Jones protein \< 4 g/24h) Stage II: Overall data as minimally abnormal for stage I, and no single value as abnormal as defined for stage III Stage III: 1 or more of below: Hemoglobin \< 8.5 g/dL; serum calcium \> 12 mg/dL; Advanced lytic bone lesions (scale 3); High-M-component production rates (IgG value \> 7 g/dL, IgA value \> 5 g/dL; Bence Jones protein \> 12 g/24h)
    param Type
    NUMBER
    title
    Durie-Salmon Multiple Myeloma Stage before Study Entry
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.72
          value
          7.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time From First Pathologic Diagnosis
    unit Of Measure
    years
population Description
The intent-to-treat (ITT) population was defined as all enrolled participants.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice