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NCT00434161 · BASELINE

Baseline characteristics

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma · Source last updated 2015-03-30

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
      109
    2. group Id
      BG001
      value
      57
    3. group Id
      BG002
      value
      115
    4. group Id
      BG003
      value
      281
    units
    Participants
groups
  1. description
    Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
    id
    BG000
    title
    Palifermin Before Only
  2. description
    Subjects to receive matched placebo before- and after-high dose chemotherapy
    id
    BG001
    title
    Placebo
  3. description
    Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
    id
    BG002
    title
    Palifermin Before and After
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. 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
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          90
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          100
        4. group Id
          BG003
          value
          239
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          42
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.4
          value
          55.3
        2. group Id
          BG001
          spread
          7.0
          value
          57.1
        3. group Id
          BG002
          spread
          7.5
          value
          56.1
        4. group Id
          BG003
          spread
          7.7
          value
          56
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          126
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          63
        4. group Id
          BG003
          value
          155
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          48
      title
      Germany
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          47
      title
      Hungary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          41
      title
      France
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          30
      title
      Austria
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          20
      title
      Belgium
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          18
      title
      Czech Republic
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          17
      title
      Italy
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          15
      title
      Switzerland
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          11
      title
      United Kingdom
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
      title
      Finland
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          10
      title
      Netherlands
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
      title
      Ireland
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      109
    2. group Id
      BG001
      value
      57
    3. group Id
      BG002
      value
      115
    4. group Id
      BG003
      value
      281
    units
    Participants
groups
  1. description
    Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
    id
    BG000
    title
    Palifermin Before Only
  2. description
    Subjects to receive matched placebo before- and after-high dose chemotherapy
    id
    BG001
    title
    Placebo
  3. description
    Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
    id
    BG002
    title
    Palifermin Before and After
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. 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
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          90
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          100
        4. group Id
          BG003
          value
          239
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          42
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.4
          value
          55.3
        2. group Id
          BG001
          spread
          7.0
          value
          57.1
        3. group Id
          BG002
          spread
          7.5
          value
          56.1
        4. group Id
          BG003
          spread
          7.7
          value
          56
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          126
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          63
        4. group Id
          BG003
          value
          155
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          48
      title
      Germany
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          47
      title
      Hungary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          41
      title
      France
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          30
      title
      Austria
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          20
      title
      Belgium
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          18
      title
      Czech Republic
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          17
      title
      Italy
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          15
      title
      Switzerland
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          11
      title
      United Kingdom
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
      title
      Finland
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          10
      title
      Netherlands
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
      title
      Ireland
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice