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NCT00661999 · BASELINE

Baseline characteristics

Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer · Source last updated 2011-05-17

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
      164
    2. group Id
      BG001
      value
      163
    3. group Id
      BG002
      value
      163
    4. group Id
      BG003
      value
      490
    units
    Participants
groups
  1. description
    Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
    id
    BG000
    title
    DA + IV Iron
  2. description
    Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
    id
    BG001
    title
    DA + Oral Iron
  3. description
    Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
    id
    BG002
    title
    DA + Placebo
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11
          value
          64
        2. group Id
          BG001
          spread
          13
          value
          63
        3. group Id
          BG002
          spread
          11
          value
          63
        4. group Id
          BG003
          spread
          12
          value
          63
    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
          109
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          105
        4. group Id
          BG003
          value
          320
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          58
        4. group Id
          BG003
          value
          170
        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
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          17
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          155
        2. group Id
          BG001
          value
          147
        3. group Id
          BG002
          value
          156
        4. group Id
          BG003
          value
          458
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          7
        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
          123
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          123
        4. group Id
          BG003
          value
          369
      title
      Mild: Hemoglobin>=9.5
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          121
      title
      Severe: Hemoglobin <9.5
    param Type
    NUMBER
    title
    Degree of Anemia
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          236
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          85
        4. group Id
          BG003
          value
          254
      title
      No
    param Type
    NUMBER
    title
    Platinum-Containing Regimen
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          25
      title
      Hematologic Neoplasm
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          157
        2. group Id
          BG001
          value
          154
        3. group Id
          BG002
          value
          151
        4. group Id
          BG003
          value
          462
      title
      Solid Tumor
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Both
    param Type
    NUMBER
    title
    Tumor Type
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          18.74
          value
          77.4
        2. group Id
          BG001
          spread
          19.75
          value
          79.4
        3. group Id
          BG002
          spread
          17.68
          value
          76.4
        4. group Id
          BG003
          spread
          18.75
          value
          77.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.44
          value
          166.9
        2. group Id
          BG001
          spread
          8.93
          value
          167.7
        3. group Id
          BG002
          spread
          9.36
          value
          166.8
        4. group Id
          BG003
          spread
          9.24
          value
          167.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          526.99
          value
          460.5
        2. group Id
          BG001
          spread
          484.15
          value
          479.5
        3. group Id
          BG002
          spread
          479.27
          value
          456.0
        4. group Id
          BG003
          spread
          496.41
          value
          465.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Ferritin
    unit Of Measure
    µg/L
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.81
          value
          22.5
        2. group Id
          BG001
          spread
          11.7
          value
          19.6
        3. group Id
          BG002
          spread
          13.36
          value
          22.2
        4. group Id
          BG003
          spread
          12.69
          value
          21.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Transferrin Saturation
    unit Of Measure
    Percentage Saturation
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      164
    2. group Id
      BG001
      value
      163
    3. group Id
      BG002
      value
      163
    4. group Id
      BG003
      value
      490
    units
    Participants
groups
  1. description
    Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
    id
    BG000
    title
    DA + IV Iron
  2. description
    Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
    id
    BG001
    title
    DA + Oral Iron
  3. description
    Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
    id
    BG002
    title
    DA + Placebo
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11
          value
          64
        2. group Id
          BG001
          spread
          13
          value
          63
        3. group Id
          BG002
          spread
          11
          value
          63
        4. group Id
          BG003
          spread
          12
          value
          63
    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
          109
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          105
        4. group Id
          BG003
          value
          320
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          58
        4. group Id
          BG003
          value
          170
        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
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          17
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          155
        2. group Id
          BG001
          value
          147
        3. group Id
          BG002
          value
          156
        4. group Id
          BG003
          value
          458
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          7
        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
          123
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          123
        4. group Id
          BG003
          value
          369
      title
      Mild: Hemoglobin>=9.5
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          121
      title
      Severe: Hemoglobin <9.5
    param Type
    NUMBER
    title
    Degree of Anemia
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          236
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          85
        4. group Id
          BG003
          value
          254
      title
      No
    param Type
    NUMBER
    title
    Platinum-Containing Regimen
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          25
      title
      Hematologic Neoplasm
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          157
        2. group Id
          BG001
          value
          154
        3. group Id
          BG002
          value
          151
        4. group Id
          BG003
          value
          462
      title
      Solid Tumor
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Both
    param Type
    NUMBER
    title
    Tumor Type
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          18.74
          value
          77.4
        2. group Id
          BG001
          spread
          19.75
          value
          79.4
        3. group Id
          BG002
          spread
          17.68
          value
          76.4
        4. group Id
          BG003
          spread
          18.75
          value
          77.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.44
          value
          166.9
        2. group Id
          BG001
          spread
          8.93
          value
          167.7
        3. group Id
          BG002
          spread
          9.36
          value
          166.8
        4. group Id
          BG003
          spread
          9.24
          value
          167.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          526.99
          value
          460.5
        2. group Id
          BG001
          spread
          484.15
          value
          479.5
        3. group Id
          BG002
          spread
          479.27
          value
          456.0
        4. group Id
          BG003
          spread
          496.41
          value
          465.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Ferritin
    unit Of Measure
    µg/L
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.81
          value
          22.5
        2. group Id
          BG001
          spread
          11.7
          value
          19.6
        3. group Id
          BG002
          spread
          13.36
          value
          22.2
        4. group Id
          BG003
          spread
          12.69
          value
          21.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Transferrin Saturation
    unit Of Measure
    Percentage Saturation

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