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NCT00416624 · BASELINE

Baseline characteristics

Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy · Source last updated 2017-02-10

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
      61
    2. group Id
      BG001
      value
      60
    3. group Id
      BG002
      value
      58
    4. group Id
      BG003
      value
      57
    5. group Id
      BG004
      value
      236
    units
    Participants
groups
  1. description
    Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
    id
    BG000
    title
    Epoetin Alfa - 40k Weekly
  2. description
    Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
    id
    BG001
    title
    Epoetin Alfa - 80k Every 3 Weeks
  3. description
    Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
    id
    BG002
    title
    Epoetin Alfa - 120k Every 3 Weeks
  4. description
    Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
    id
    BG003
    title
    Darbepoetin Alfa - 500 mcg Every 3 Weeks
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          44.0
          upper Limit
          94.0
          value
          65.0
        2. group Id
          BG001
          lower Limit
          37.0
          upper Limit
          91.0
          value
          68.0
        3. group Id
          BG002
          lower Limit
          19.0
          upper Limit
          81.0
          value
          65.0
        4. group Id
          BG003
          lower Limit
          40.0
          upper Limit
          89.0
          value
          67.0
        5. group Id
          BG004
          lower Limit
          19.0
          upper Limit
          94.0
          value
          66.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          42
        5. group Id
          BG004
          value
          136
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          100
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    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
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          14
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          52
        5. group Id
          BG004
          value
          219
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          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
          value
          61
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          58
        4. group Id
          BG003
          value
          57
        5. group Id
          BG004
          value
          236
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          42
        5. group Id
          BG004
          value
          173
      title
      Mild: Hemoglobin of 9.5-11
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          63
      title
      Severe: Hemoglobin < 9.5
    param Type
    NUMBER
    title
    Anemia
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          25
        5. group Id
          BG004
          value
          106
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          130
      title
      No
    param Type
    NUMBER
    title
    Platinum Containing Regimen
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          20
      title
      Hematologic
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          53
        4. group Id
          BG003
          value
          53
        5. group Id
          BG004
          value
          216
      title
      Solid Tumor
    param Type
    NUMBER
    title
    Primary Tumor Type
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          149.7
          upper Limit
          193.0
          value
          167.6
        2. group Id
          BG001
          lower Limit
          154.0
          upper Limit
          201.0
          value
          168.0
        3. group Id
          BG002
          lower Limit
          150.0
          upper Limit
          190.0
          value
          165.2
        4. group Id
          BG003
          lower Limit
          152.4
          upper Limit
          187.0
          value
          166.5
        5. group Id
          BG004
          lower Limit
          149.7
          upper Limit
          201.0
          value
          167.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Height
    unit Of Measure
    cm
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          7.8
          upper Limit
          10.6
          value
          10.1
        2. group Id
          BG001
          lower Limit
          8.4
          upper Limit
          10.5
          value
          9.9
        3. group Id
          BG002
          lower Limit
          7.7
          upper Limit
          10.5
          value
          9.9
        4. group Id
          BG003
          lower Limit
          7.4
          upper Limit
          10.5
          value
          9.9
        5. group Id
          BG004
          lower Limit
          7.4
          upper Limit
          10.6
          value
          9.9
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Baseline Hemoglobin
    unit Of Measure
    g/dL
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          44.5
          upper Limit
          125.4
          value
          69.1
        2. group Id
          BG001
          lower Limit
          51.3
          upper Limit
          133.0
          value
          72.6
        3. group Id
          BG002
          lower Limit
          44.1
          upper Limit
          120.0
          value
          70.6
        4. group Id
          BG003
          lower Limit
          42.5
          upper Limit
          141.0
          value
          71.0
        5. group Id
          BG004
          lower Limit
          42.5
          upper Limit
          141.0
          value
          71.3
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Weight
    unit Of Measure
    kg
population Description
All patients that were evaluable per protocol.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      61
    2. group Id
      BG001
      value
      60
    3. group Id
      BG002
      value
      58
    4. group Id
      BG003
      value
      57
    5. group Id
      BG004
      value
      236
    units
    Participants
groups
  1. description
    Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
    id
    BG000
    title
    Epoetin Alfa - 40k Weekly
  2. description
    Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
    id
    BG001
    title
    Epoetin Alfa - 80k Every 3 Weeks
  3. description
    Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
    id
    BG002
    title
    Epoetin Alfa - 120k Every 3 Weeks
  4. description
    Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
    id
    BG003
    title
    Darbepoetin Alfa - 500 mcg Every 3 Weeks
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          44.0
          upper Limit
          94.0
          value
          65.0
        2. group Id
          BG001
          lower Limit
          37.0
          upper Limit
          91.0
          value
          68.0
        3. group Id
          BG002
          lower Limit
          19.0
          upper Limit
          81.0
          value
          65.0
        4. group Id
          BG003
          lower Limit
          40.0
          upper Limit
          89.0
          value
          67.0
        5. group Id
          BG004
          lower Limit
          19.0
          upper Limit
          94.0
          value
          66.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          42
        5. group Id
          BG004
          value
          136
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          100
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    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
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          14
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          52
        5. group Id
          BG004
          value
          219
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          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
          value
          61
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          58
        4. group Id
          BG003
          value
          57
        5. group Id
          BG004
          value
          236
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          42
        5. group Id
          BG004
          value
          173
      title
      Mild: Hemoglobin of 9.5-11
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          63
      title
      Severe: Hemoglobin < 9.5
    param Type
    NUMBER
    title
    Anemia
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          25
        5. group Id
          BG004
          value
          106
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          130
      title
      No
    param Type
    NUMBER
    title
    Platinum Containing Regimen
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          20
      title
      Hematologic
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          53
        4. group Id
          BG003
          value
          53
        5. group Id
          BG004
          value
          216
      title
      Solid Tumor
    param Type
    NUMBER
    title
    Primary Tumor Type
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          149.7
          upper Limit
          193.0
          value
          167.6
        2. group Id
          BG001
          lower Limit
          154.0
          upper Limit
          201.0
          value
          168.0
        3. group Id
          BG002
          lower Limit
          150.0
          upper Limit
          190.0
          value
          165.2
        4. group Id
          BG003
          lower Limit
          152.4
          upper Limit
          187.0
          value
          166.5
        5. group Id
          BG004
          lower Limit
          149.7
          upper Limit
          201.0
          value
          167.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Height
    unit Of Measure
    cm
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          7.8
          upper Limit
          10.6
          value
          10.1
        2. group Id
          BG001
          lower Limit
          8.4
          upper Limit
          10.5
          value
          9.9
        3. group Id
          BG002
          lower Limit
          7.7
          upper Limit
          10.5
          value
          9.9
        4. group Id
          BG003
          lower Limit
          7.4
          upper Limit
          10.5
          value
          9.9
        5. group Id
          BG004
          lower Limit
          7.4
          upper Limit
          10.6
          value
          9.9
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Baseline Hemoglobin
    unit Of Measure
    g/dL
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          44.5
          upper Limit
          125.4
          value
          69.1
        2. group Id
          BG001
          lower Limit
          51.3
          upper Limit
          133.0
          value
          72.6
        3. group Id
          BG002
          lower Limit
          44.1
          upper Limit
          120.0
          value
          70.6
        4. group Id
          BG003
          lower Limit
          42.5
          upper Limit
          141.0
          value
          71.0
        5. group Id
          BG004
          lower Limit
          42.5
          upper Limit
          141.0
          value
          71.3
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Weight
    unit Of Measure
    kg
population Description
All patients that were evaluable per protocol.

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