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NCT02098109 · BASELINE

Baseline characteristics

Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma · Source last updated 2017-07-18

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
      46
    2. group Id
      BG001
      value
      51
    3. group Id
      BG002
      value
      97
    units
    Participants
groups
  1. description
    XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
    id
    BG000
    title
    XM02 Filgrastim (Granix) and Plerixafor
  2. description
    Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
    id
    BG001
    title
    Filgrastim (Neupogen) and Plerixafor
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.3
          value
          62.9
        2. group Id
          BG001
          spread
          9.0
          value
          58.5
        3. group Id
          BG002
          spread
          8.9
          value
          60.6
    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
          16
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          37
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          60
        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
          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
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          85
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        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
          value
          46
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          97
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.8
          value
          1.5
        2. group Id
          BG001
          spread
          0.8
          value
          1.4
        3. group Id
          BG002
          spread
          0.8
          value
          1.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Prior Therapies
    unit Of Measure
    number of prior therapies
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          86
        title
        Multiple myeloma
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        title
        Non-Hodgkin's Lymphoma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diagnosis
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          23
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Radiation
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      46
    2. group Id
      BG001
      value
      51
    3. group Id
      BG002
      value
      97
    units
    Participants
groups
  1. description
    XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
    id
    BG000
    title
    XM02 Filgrastim (Granix) and Plerixafor
  2. description
    Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
    id
    BG001
    title
    Filgrastim (Neupogen) and Plerixafor
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.3
          value
          62.9
        2. group Id
          BG001
          spread
          9.0
          value
          58.5
        3. group Id
          BG002
          spread
          8.9
          value
          60.6
    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
          16
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          37
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          60
        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
          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
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          85
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        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
          value
          46
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          97
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.8
          value
          1.5
        2. group Id
          BG001
          spread
          0.8
          value
          1.4
        3. group Id
          BG002
          spread
          0.8
          value
          1.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Prior Therapies
    unit Of Measure
    number of prior therapies
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          86
        title
        Multiple myeloma
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        title
        Non-Hodgkin's Lymphoma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diagnosis
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          23
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Radiation
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice