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NCT00295750 · BASELINE

Baseline characteristics

The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer · Source last updated 2012-12-19

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
      202
    2. group Id
      BG001
      value
      207
    3. group Id
      BG002
      value
      201
    4. group Id
      BG003
      value
      610
    units
    Participants
groups
  1. description
    Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
    id
    BG000
    title
    Degarelix 240/160 mg
  2. description
    Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
    id
    BG001
    title
    Degarelix 240/80 mg
  3. description
    Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
    id
    BG002
    title
    Leuprolide 7.5 mg
  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
          37
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          118
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          164
        3. group Id
          BG002
          value
          163
        4. group Id
          BG003
          value
          492
        title
        >=65 years
    description
    Intent-to-treat (ITT) population.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          50
          spread
          8.47
          upper Limit
          88
          value
          72
        2. group Id
          BG001
          lower Limit
          51
          spread
          8.12
          upper Limit
          89
          value
          72
        3. group Id
          BG002
          lower Limit
          52
          spread
          8.77
          upper Limit
          98
          value
          74
        4. group Id
          BG003
          lower Limit
          50
          spread
          8.45
          upper Limit
          98
          value
          73
    description
    ITT population.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age Continuous
    unit Of Measure
    years
  3. 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
        Female
      2. measurements
        1. group Id
          BG000
          value
          202
        2. group Id
          BG001
          value
          207
        3. group Id
          BG002
          value
          201
        4. group Id
          BG003
          value
          610
        title
        Male
    description
    ITT population.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          59
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          38
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          168
        2. group Id
          BG001
          value
          171
        3. group Id
          BG002
          value
          172
        4. group Id
          BG003
          value
          511
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    description
    ITT population
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          86
        4. group Id
          BG003
          value
          257
      title
      North America
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          115
        4. group Id
          BG003
          value
          353
      title
      Europe
    description
    ITT population
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          78
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          178
        2. group Id
          BG001
          value
          177
        3. group Id
          BG002
          value
          177
        4. group Id
          BG003
          value
          532
      title
      No
    description
    ITT population. Curative intent refers to radical prostatectomy or radiotherapy.
    param Type
    NUMBER
    title
    Curative Intent
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          65
      title
      2-4
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          63
        4. group Id
          BG003
          value
          198
      title
      5-6
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          181
      title
      7
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          51
        4. group Id
          BG003
          value
          163
      title
      8-10
    description
    ITT population. The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive. Gleason scores were unavailable for 3 patients.
    param Type
    NUMBER
    title
    Gleason Score
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          63
        4. group Id
          BG003
          value
          191
      title
      Localized
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          178
      title
      Locally advanced
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          125
      title
      Metastatic
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          116
      title
      Not classifiable
    description
    ITT population. Stage of prostate cancer was classified according to the Tumour, Nodule and Metastatic classification that is a cancer staging system that describes the extent of cancer. T describes the size of the tumor and whether it has invaded nearby tissue, N describes regional lymph nodes that are involved, and M describes distant metastasis
    param Type
    NUMBER
    title
    Stage of Prostate Cancer
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.70
          value
          26.6
        2. group Id
          BG001
          spread
          4.21
          value
          26.7
        3. group Id
          BG002
          spread
          3.86
          value
          26.9
        4. group Id
          BG003
          spread
          3.93
          value
          26.8
    description
    ITT population
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index
    unit Of Measure
    kilogram per square meter
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          8.2
          upper Limit
          68
          value
          19.9
        2. group Id
          BG001
          lower Limit
          9.4
          upper Limit
          46
          value
          19.8
        3. group Id
          BG002
          lower Limit
          8.7
          upper Limit
          57
          value
          19.0
        4. group Id
          BG003
          lower Limit
          8.7
          upper Limit
          57
          value
          19.0
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Serum Prostate-specific Antigen Levels
    unit Of Measure
    nanogram per milliliter
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2.86
          upper Limit
          5.05
          value
          3.78
        2. group Id
          BG001
          lower Limit
          3.05
          upper Limit
          5.32
          value
          4.11
        3. group Id
          BG002
          lower Limit
          2.91
          upper Limit
          5.01
          value
          3.84
        4. group Id
          BG003
          lower Limit
          2.89
          upper Limit
          5.10
          value
          3.93
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Serum Testosterone Levels
    unit Of Measure
    nanogram per milliliter
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1109
          value
          485
        2. group Id
          BG001
          spread
          994
          value
          491
        3. group Id
          BG002
          spread
          1088
          value
          497
        4. group Id
          BG003
          spread
          1063
          value
          491
    description
    ITT population.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time Since Prostate Cancer Diagnosis
    unit Of Measure
    days
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      202
    2. group Id
      BG001
      value
      207
    3. group Id
      BG002
      value
      201
    4. group Id
      BG003
      value
      610
    units
    Participants
groups
  1. description
    Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
    id
    BG000
    title
    Degarelix 240/160 mg
  2. description
    Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
    id
    BG001
    title
    Degarelix 240/80 mg
  3. description
    Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
    id
    BG002
    title
    Leuprolide 7.5 mg
  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
          37
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          118
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          164
        3. group Id
          BG002
          value
          163
        4. group Id
          BG003
          value
          492
        title
        >=65 years
    description
    Intent-to-treat (ITT) population.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          50
          spread
          8.47
          upper Limit
          88
          value
          72
        2. group Id
          BG001
          lower Limit
          51
          spread
          8.12
          upper Limit
          89
          value
          72
        3. group Id
          BG002
          lower Limit
          52
          spread
          8.77
          upper Limit
          98
          value
          74
        4. group Id
          BG003
          lower Limit
          50
          spread
          8.45
          upper Limit
          98
          value
          73
    description
    ITT population.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age Continuous
    unit Of Measure
    years
  3. 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
        Female
      2. measurements
        1. group Id
          BG000
          value
          202
        2. group Id
          BG001
          value
          207
        3. group Id
          BG002
          value
          201
        4. group Id
          BG003
          value
          610
        title
        Male
    description
    ITT population.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          59
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          38
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          168
        2. group Id
          BG001
          value
          171
        3. group Id
          BG002
          value
          172
        4. group Id
          BG003
          value
          511
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    description
    ITT population
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          86
        4. group Id
          BG003
          value
          257
      title
      North America
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          115
        4. group Id
          BG003
          value
          353
      title
      Europe
    description
    ITT population
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          78
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          178
        2. group Id
          BG001
          value
          177
        3. group Id
          BG002
          value
          177
        4. group Id
          BG003
          value
          532
      title
      No
    description
    ITT population. Curative intent refers to radical prostatectomy or radiotherapy.
    param Type
    NUMBER
    title
    Curative Intent
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          65
      title
      2-4
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          63
        4. group Id
          BG003
          value
          198
      title
      5-6
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          181
      title
      7
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          51
        4. group Id
          BG003
          value
          163
      title
      8-10
    description
    ITT population. The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive. Gleason scores were unavailable for 3 patients.
    param Type
    NUMBER
    title
    Gleason Score
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          63
        4. group Id
          BG003
          value
          191
      title
      Localized
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          178
      title
      Locally advanced
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          125
      title
      Metastatic
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          116
      title
      Not classifiable
    description
    ITT population. Stage of prostate cancer was classified according to the Tumour, Nodule and Metastatic classification that is a cancer staging system that describes the extent of cancer. T describes the size of the tumor and whether it has invaded nearby tissue, N describes regional lymph nodes that are involved, and M describes distant metastasis
    param Type
    NUMBER
    title
    Stage of Prostate Cancer
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.70
          value
          26.6
        2. group Id
          BG001
          spread
          4.21
          value
          26.7
        3. group Id
          BG002
          spread
          3.86
          value
          26.9
        4. group Id
          BG003
          spread
          3.93
          value
          26.8
    description
    ITT population
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index
    unit Of Measure
    kilogram per square meter
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          8.2
          upper Limit
          68
          value
          19.9
        2. group Id
          BG001
          lower Limit
          9.4
          upper Limit
          46
          value
          19.8
        3. group Id
          BG002
          lower Limit
          8.7
          upper Limit
          57
          value
          19.0
        4. group Id
          BG003
          lower Limit
          8.7
          upper Limit
          57
          value
          19.0
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Serum Prostate-specific Antigen Levels
    unit Of Measure
    nanogram per milliliter
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2.86
          upper Limit
          5.05
          value
          3.78
        2. group Id
          BG001
          lower Limit
          3.05
          upper Limit
          5.32
          value
          4.11
        3. group Id
          BG002
          lower Limit
          2.91
          upper Limit
          5.01
          value
          3.84
        4. group Id
          BG003
          lower Limit
          2.89
          upper Limit
          5.10
          value
          3.93
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Serum Testosterone Levels
    unit Of Measure
    nanogram per milliliter
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1109
          value
          485
        2. group Id
          BG001
          spread
          994
          value
          491
        3. group Id
          BG002
          spread
          1088
          value
          497
        4. group Id
          BG003
          spread
          1063
          value
          491
    description
    ITT population.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time Since Prostate Cancer Diagnosis
    unit Of Measure
    days

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Preserved source evidence · Not medical advice