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NCT00316225 · BASELINE

Baseline characteristics

Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen · Source last updated 2010-07-09

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
      31
    units
    Participants
groups
  1. description
    Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
    id
    BG000
    title
    Pemetrexed
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          35.7
          upper Limit
          77.5
          value
          62.7
    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
          4
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          27
        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
          30
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Hispanic
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Spain
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Denmark
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      title
      Non-Small Cell Lung Cancer (NSCLC)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Mesothelioma
    description
    Diagnosis of Non-Small Cell Lung Cancer (NSCLC) and mesothelioma were determined by each individual investigator.
    param Type
    NUMBER
    title
    Diagnosis
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Stage III (locally advanced disease)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      Stage IV (metastatic disease)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Unknown
    description
    Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body).
    param Type
    NUMBER
    title
    Disease Stage
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      0 - Fully Active
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      1 - Ambulatory, Restricted Strenuous Activity
    description
    Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      Mild
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Moderate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Severe
    description
    Mild = (1) pleural effusion detectable on radiological imaging, but less than moderate; (2) ascites detectable only by radiological imaging. Moderate = (1) pleural effusion less than 1/3 of the way up the thorax on 1 side on imaging and obscuring the entire hemidiaphragm on that side; (2) ascites detectable on physical exam (that is, fluid wave is palpable). Severe = (1) pleural effusion more than 1/3 of the way up the thorax on imaging; (2) ascites visibly detectable. For Moderate Fluid Severity, there were 13 patients with pleural effusion and 1 patient with ascites.
    param Type
    NUMBER
    title
    Fluid Severity
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Cytological
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      title
      Histopathological
    param Type
    NUMBER
    title
    Primary Basis for Diagnosis
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
      title
      Pleural Effusion
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Ascites
    param Type
    NUMBER
    title
    Type of Third-Space Fluid
    unit Of Measure
    participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.4
          upper Limit
          2.3
          value
          1.8
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Body Surface Area
    unit Of Measure
    meters squared (m^2)
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          147.0
          upper Limit
          189.0
          value
          171.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Height
    unit Of Measure
    centimeters (cm)
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      31
    units
    Participants
groups
  1. description
    Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
    id
    BG000
    title
    Pemetrexed
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          35.7
          upper Limit
          77.5
          value
          62.7
    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
          4
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          27
        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
          30
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Hispanic
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Spain
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Denmark
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      title
      Non-Small Cell Lung Cancer (NSCLC)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Mesothelioma
    description
    Diagnosis of Non-Small Cell Lung Cancer (NSCLC) and mesothelioma were determined by each individual investigator.
    param Type
    NUMBER
    title
    Diagnosis
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Stage III (locally advanced disease)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      Stage IV (metastatic disease)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Unknown
    description
    Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body).
    param Type
    NUMBER
    title
    Disease Stage
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      0 - Fully Active
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      1 - Ambulatory, Restricted Strenuous Activity
    description
    Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      Mild
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Moderate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Severe
    description
    Mild = (1) pleural effusion detectable on radiological imaging, but less than moderate; (2) ascites detectable only by radiological imaging. Moderate = (1) pleural effusion less than 1/3 of the way up the thorax on 1 side on imaging and obscuring the entire hemidiaphragm on that side; (2) ascites detectable on physical exam (that is, fluid wave is palpable). Severe = (1) pleural effusion more than 1/3 of the way up the thorax on imaging; (2) ascites visibly detectable. For Moderate Fluid Severity, there were 13 patients with pleural effusion and 1 patient with ascites.
    param Type
    NUMBER
    title
    Fluid Severity
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Cytological
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      title
      Histopathological
    param Type
    NUMBER
    title
    Primary Basis for Diagnosis
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
      title
      Pleural Effusion
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Ascites
    param Type
    NUMBER
    title
    Type of Third-Space Fluid
    unit Of Measure
    participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.4
          upper Limit
          2.3
          value
          1.8
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Body Surface Area
    unit Of Measure
    meters squared (m^2)
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          147.0
          upper Limit
          189.0
          value
          171.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Height
    unit Of Measure
    centimeters (cm)

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Preserved source evidence · Not medical advice