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NCT04843007 · BASELINE

Baseline characteristics

Alvopem® (Pemetrexed) Safety Assessment · Source last updated 2024-10-23

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
      198
    units
    Participants
groups
  1. description
    500 mg/m\^2 pemetrexed, IV infusion Pemetrexed: Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2
    id
    BG000
    title
    NanoAlvand Pemetrexed
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.36
          value
          61.11
    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
          68
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          130
        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
          198
        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
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        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
          spread
          14.74
          value
          66.93
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    Kg
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.88
          value
          166.44
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.21
          value
          1.75
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area (BSA)
    unit Of Measure
    m^2
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          132
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smokers
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          186
        title
        NSCLC
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        MPM
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diagnosis
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.22
          value
          1.02
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Serum Creatinine (SCr)
    unit Of Measure
    mg/dL
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.30
          value
          0.46
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Bilirubin
    unit Of Measure
    mg/dL
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.34
          value
          31.24
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Blood Urea Nitrogen (BUN)
    unit Of Measure
    mg/dL
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          21.72
          value
          23.78
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Aspartate Aminotransferase (AST)
    unit Of Measure
    units/L
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      198
    units
    Participants
groups
  1. description
    500 mg/m\^2 pemetrexed, IV infusion Pemetrexed: Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2
    id
    BG000
    title
    NanoAlvand Pemetrexed
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.36
          value
          61.11
    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
          68
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          130
        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
          198
        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
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        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
          spread
          14.74
          value
          66.93
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    Kg
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.88
          value
          166.44
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.21
          value
          1.75
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area (BSA)
    unit Of Measure
    m^2
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          132
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smokers
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          186
        title
        NSCLC
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        MPM
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diagnosis
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.22
          value
          1.02
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Serum Creatinine (SCr)
    unit Of Measure
    mg/dL
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.30
          value
          0.46
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Bilirubin
    unit Of Measure
    mg/dL
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.34
          value
          31.24
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Blood Urea Nitrogen (BUN)
    unit Of Measure
    mg/dL
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          21.72
          value
          23.78
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Aspartate Aminotransferase (AST)
    unit Of Measure
    units/L

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Preserved source evidence · Not medical advice