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NCT01459653 · BASELINE

Baseline characteristics

Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor · Source last updated 2016-01-11

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
      1447
    units
    Participants
groups
  1. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Only patients who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data) belong to the evaluable sample and are analyzed.
    id
    BG000
    title
    EP2006, Evaluable Sample
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.8
          value
          61.3
    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
          886
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          561
        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
          1042
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      African
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          395
      title
      Missing
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          395
      title
      France
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          143
      title
      Hungary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          50
      title
      Czech Republic
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          116
      title
      Spain
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          286
      title
      Poland
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Belgium
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          64
      title
      Romania
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      Austria
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          145
      title
      Germany
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          32
      title
      United Kingdom
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Switzerland
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          175
      title
      Italy
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.5
          value
          165.6
    description
    Number of participants analyzed: 1358
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.0
          value
          72.1
    description
    Number of participants analyzed: 1357
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.0
          value
          26.3
    description
    Number of participants analyzed: 1354
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body-Mass Index (BMI)
    unit Of Measure
    kg/m^2
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          116
      title
      Bone pain
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          78
      title
      Joint pain
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          31
      title
      Muscle pain
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          28
      title
      Headache
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Epistaxis
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      GI bleeding
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Skin hemorrhage
    description
    Medical history for each patient was recorded. A patient can fall into more than one or none of the categories displayed.
    param Type
    NUMBER
    title
    Medical history
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          458
      title
      Hypertension
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          138
      title
      Anemia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          122
      title
      Diabetes Type II
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          93
      title
      Coronary disease
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          90
      title
      Allergies
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          86
      title
      COPD
    description
    Comorbidities for each patient were recorded. Only those comorbidities with a relative frequency of 5% or more are displayed in the table. A patient can fall into more than one or none of the categories displayed.
    param Type
    NUMBER
    title
    Comorbidities
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          35
      title
      History of any repeated infection
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Type of repeated infection (chronic)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      Type of repeated infection (recurrent, acute)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      1 infectious episode in past 3 months
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      2 infectious episodes in past 3 months
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      3 or more infectious episodes in past 3 months
    description
    History of repeated infections for each patient was recoded. A patient can fall into more than one or none of the categories displayed.
    param Type
    NUMBER
    title
    History of repeated infections
    unit Of Measure
    participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          466
      title
      Breast
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          345
      title
      Lung
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          245
      title
      Lymphoma (DLBCL)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          140
      title
      Ovarian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          102
      title
      Prostate
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          85
      title
      Multiple myeloma
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          64
      title
      Bladder
    param Type
    NUMBER
    title
    Cancer type
    unit Of Measure
    participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          267
      title
      Breast (stage III, n=466)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          194
      title
      Breast (stage IV, n=466)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          101
      title
      Lung (stage III, n=345)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          241
      title
      Lung (stage IV, n=345)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          103
      title
      Lymphoma (DLBCL) (stage III, n=245)
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          135
      title
      Lymphoma (DLBCL) (stage IV, n=245)
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          63
      title
      Ovarian (stage III, n=140)
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          77
      title
      Ovarian (stage IV, n=140)
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Prostate (stage III, n=102)
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          95
      title
      Prostate (stage IV, n=102)
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          53
      title
      Multiple myeloma (stage III, n=85)
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Multiple myeloma (stage IV, n=85)
    description
    Table presents cancer stage by cancer stage. In addition, table presents cancer stage for all patients.
    param Type
    NUMBER
    title
    Cancer stage & type
    unit Of Measure
    participants
population Description
Baseline characteristics are based on the evaluable sample, e.g. all patients who received at least one dose of the study medication, had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1447
    units
    Participants
groups
  1. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Only patients who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data) belong to the evaluable sample and are analyzed.
    id
    BG000
    title
    EP2006, Evaluable Sample
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.8
          value
          61.3
    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
          886
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          561
        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
          1042
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      African
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          395
      title
      Missing
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          395
      title
      France
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          143
      title
      Hungary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          50
      title
      Czech Republic
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          116
      title
      Spain
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          286
      title
      Poland
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Belgium
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          64
      title
      Romania
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      Austria
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          145
      title
      Germany
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          32
      title
      United Kingdom
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Switzerland
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          175
      title
      Italy
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.5
          value
          165.6
    description
    Number of participants analyzed: 1358
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.0
          value
          72.1
    description
    Number of participants analyzed: 1357
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.0
          value
          26.3
    description
    Number of participants analyzed: 1354
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body-Mass Index (BMI)
    unit Of Measure
    kg/m^2
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          116
      title
      Bone pain
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          78
      title
      Joint pain
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          31
      title
      Muscle pain
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          28
      title
      Headache
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Epistaxis
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      GI bleeding
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Skin hemorrhage
    description
    Medical history for each patient was recorded. A patient can fall into more than one or none of the categories displayed.
    param Type
    NUMBER
    title
    Medical history
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          458
      title
      Hypertension
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          138
      title
      Anemia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          122
      title
      Diabetes Type II
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          93
      title
      Coronary disease
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          90
      title
      Allergies
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          86
      title
      COPD
    description
    Comorbidities for each patient were recorded. Only those comorbidities with a relative frequency of 5% or more are displayed in the table. A patient can fall into more than one or none of the categories displayed.
    param Type
    NUMBER
    title
    Comorbidities
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          35
      title
      History of any repeated infection
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Type of repeated infection (chronic)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      Type of repeated infection (recurrent, acute)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      1 infectious episode in past 3 months
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      2 infectious episodes in past 3 months
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      3 or more infectious episodes in past 3 months
    description
    History of repeated infections for each patient was recoded. A patient can fall into more than one or none of the categories displayed.
    param Type
    NUMBER
    title
    History of repeated infections
    unit Of Measure
    participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          466
      title
      Breast
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          345
      title
      Lung
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          245
      title
      Lymphoma (DLBCL)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          140
      title
      Ovarian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          102
      title
      Prostate
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          85
      title
      Multiple myeloma
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          64
      title
      Bladder
    param Type
    NUMBER
    title
    Cancer type
    unit Of Measure
    participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          267
      title
      Breast (stage III, n=466)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          194
      title
      Breast (stage IV, n=466)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          101
      title
      Lung (stage III, n=345)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          241
      title
      Lung (stage IV, n=345)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          103
      title
      Lymphoma (DLBCL) (stage III, n=245)
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          135
      title
      Lymphoma (DLBCL) (stage IV, n=245)
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          63
      title
      Ovarian (stage III, n=140)
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          77
      title
      Ovarian (stage IV, n=140)
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Prostate (stage III, n=102)
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          95
      title
      Prostate (stage IV, n=102)
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          53
      title
      Multiple myeloma (stage III, n=85)
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Multiple myeloma (stage IV, n=85)
    description
    Table presents cancer stage by cancer stage. In addition, table presents cancer stage for all patients.
    param Type
    NUMBER
    title
    Cancer stage & type
    unit Of Measure
    participants
population Description
Baseline characteristics are based on the evaluable sample, e.g. all patients who received at least one dose of the study medication, had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data).

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