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NCT00102804 · BASELINE

Baseline characteristics

Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2014-12-29

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
      441
    2. group Id
      BG001
      value
      222
    3. group Id
      BG002
      value
      663
    units
    Participants
groups
  1. description
    Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
    id
    BG000
    title
    Pemetrexed and BSC
  2. description
    Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
    id
    BG001
    title
    Placebo and BSC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          54.3
          upper Limit
          67.5
          value
          60.6
        2. group Id
          BG001
          lower Limit
          53.8
          upper Limit
          67.0
          value
          60.4
        3. group Id
          BG002
          lower Limit
          54.1
          upper Limit
          67.4
          value
          60.6
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          180
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          322
        2. group Id
          BG001
          value
          161
        3. group Id
          BG002
          value
          483
        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
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Aboriginal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          6
      title
      African
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          279
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          428
      title
      Caucasian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          154
      title
      East Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          19
      title
      Hispanic
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          55
      title
      West Asian
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          32
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
      title
      Taiwan
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          27
      title
      Greece
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          49
      title
      Spain
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
      title
      Turkey
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Austria
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          34
      title
      Italy
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          55
      title
      India
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
      title
      Hungary
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
      title
      Czech Republic
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          36
      title
      Poland
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          34
      title
      Brazil
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      441
    2. group Id
      BG001
      value
      222
    3. group Id
      BG002
      value
      663
    units
    Participants
groups
  1. description
    Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
    id
    BG000
    title
    Pemetrexed and BSC
  2. description
    Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
    id
    BG001
    title
    Placebo and BSC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          54.3
          upper Limit
          67.5
          value
          60.6
        2. group Id
          BG001
          lower Limit
          53.8
          upper Limit
          67.0
          value
          60.4
        3. group Id
          BG002
          lower Limit
          54.1
          upper Limit
          67.4
          value
          60.6
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          180
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          322
        2. group Id
          BG001
          value
          161
        3. group Id
          BG002
          value
          483
        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
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Aboriginal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          6
      title
      African
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          279
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          428
      title
      Caucasian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          154
      title
      East Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          19
      title
      Hispanic
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          55
      title
      West Asian
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          32
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
      title
      Taiwan
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          27
      title
      Greece
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          49
      title
      Spain
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
      title
      Turkey
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Austria
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          34
      title
      Italy
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          55
      title
      India
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
      title
      Hungary
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
      title
      Czech Republic
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          36
      title
      Poland
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          34
      title
      Brazil
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized.

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Preserved source evidence · Not medical advice