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NCT03252431 · BASELINE

Baseline characteristics

Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy · Source last updated 2023-07-03

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
      197
    2. group Id
      BG001
      value
      196
    3. group Id
      BG002
      value
      393
    units
    Participants
groups
  1. description
    F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles. F-627: single dose pre-filled syringe
    id
    BG000
    title
    F-627
  2. description
    6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles Neulasta: single dose pre-filled syringe
    id
    BG001
    title
    Neulasta
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.82
          value
          51.4
        2. group Id
          BG001
          spread
          11.11
          value
          53.4
        3. group Id
          BG002
          spread
          11.50
          value
          52.4
    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
          197
        2. group Id
          BG001
          value
          196
        3. group Id
          BG002
          value
          393
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          197
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          392
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          197
        2. group Id
          BG001
          value
          196
        3. group Id
          BG002
          value
          393
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          36
      title
      Bulgaria
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          45
      title
      Hungary
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          145
      title
      Russia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          166
      title
      Ukraine
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.884
          value
          75.84
        2. group Id
          BG001
          spread
          16.873
          value
          74.93
        3. group Id
          BG002
          spread
          16.863
          value
          75.39
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.27
          value
          162.6
        2. group Id
          BG001
          spread
          6.67
          value
          162.2
        3. group Id
          BG002
          spread
          6.47
          value
          162.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.358
          value
          28.72
        2. group Id
          BG001
          spread
          6.197
          value
          28.51
        3. group Id
          BG002
          spread
          6.271
          value
          28.62
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Basal Metabolic Index
    unit Of Measure
    kg/m2
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      197
    2. group Id
      BG001
      value
      196
    3. group Id
      BG002
      value
      393
    units
    Participants
groups
  1. description
    F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles. F-627: single dose pre-filled syringe
    id
    BG000
    title
    F-627
  2. description
    6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles Neulasta: single dose pre-filled syringe
    id
    BG001
    title
    Neulasta
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.82
          value
          51.4
        2. group Id
          BG001
          spread
          11.11
          value
          53.4
        3. group Id
          BG002
          spread
          11.50
          value
          52.4
    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
          197
        2. group Id
          BG001
          value
          196
        3. group Id
          BG002
          value
          393
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          197
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          392
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          197
        2. group Id
          BG001
          value
          196
        3. group Id
          BG002
          value
          393
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          36
      title
      Bulgaria
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          45
      title
      Hungary
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          145
      title
      Russia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          166
      title
      Ukraine
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.884
          value
          75.84
        2. group Id
          BG001
          spread
          16.873
          value
          74.93
        3. group Id
          BG002
          spread
          16.863
          value
          75.39
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.27
          value
          162.6
        2. group Id
          BG001
          spread
          6.67
          value
          162.2
        3. group Id
          BG002
          spread
          6.47
          value
          162.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.358
          value
          28.72
        2. group Id
          BG001
          spread
          6.197
          value
          28.51
        3. group Id
          BG002
          spread
          6.271
          value
          28.62
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Basal Metabolic Index
    unit Of Measure
    kg/m2

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Preserved source evidence · Not medical advice