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NCT00451958 · BASELINE

Baseline characteristics

A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy · Source last updated 2013-03-21

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
      125
    2. group Id
      BG001
      value
      126
    3. group Id
      BG002
      value
      69
    4. group Id
      BG003
      value
      65
    5. group Id
      BG004
      value
      385
    units
    Participants
groups
  1. description
    The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
    id
    BG000
    title
    Degarelix 80 mg / Degarelix 80 mg
  2. description
    The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    id
    BG001
    title
    Degarelix 160 mg / Degarelix 160 mg
  3. description
    During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    id
    BG002
    title
    Leuprolide 7.5 mg / Degarelix 80 mg
  4. description
    During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    id
    BG003
    title
    Leuprolide 7.5 mg / Degarelix 160 mg
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.62
          value
          70.1
        2. group Id
          BG001
          spread
          8.25
          value
          71.1
        3. group Id
          BG002
          spread
          9.46
          value
          72.4
        4. group Id
          BG003
          spread
          8.24
          value
          71.4
        5. group Id
          BG004
          spread
          8.29
          value
          71.1
    description
    CS21A intention-to-treat (ITT) population.
    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
          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
        Female
      2. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          69
        4. group Id
          BG003
          value
          65
        5. group Id
          BG004
          value
          385
        title
        Male
    description
    CS21A ITT population.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          48
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          26
      title
      Hungary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          37
      title
      Czech Republic
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          49
      title
      Mexico
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          18
      title
      Canada
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          31
      title
      Ukraine
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          106
      title
      Romania
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          64
      title
      Russian Federation
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
      title
      Netherlands
    10. 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
      Germany
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
      title
      United Kingdom
    description
    CS21A ITT population.
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.6
          value
          78.4
        2. group Id
          BG001
          spread
          13.4
          value
          79.2
        3. group Id
          BG002
          spread
          11.3
          value
          78.7
        4. group Id
          BG003
          spread
          12.1
          value
          80.0
        5. group Id
          BG004
          spread
          12.5
          value
          79.0
    description
    CS21A ITT population.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Weight
    unit Of Measure
    kilogram
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.92
          value
          26.4
        2. group Id
          BG001
          spread
          3.79
          value
          26.9
        3. group Id
          BG002
          spread
          3.94
          value
          26.9
        4. group Id
          BG003
          spread
          3.67
          value
          27.1
        5. group Id
          BG004
          spread
          3.84
          value
          26.8
    description
    CS21A ITT population.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index
    unit Of Measure
    kilogram per square meter
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          51
      title
      Gleason Score 2-4
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          124
      title
      Gleason Score 5-6
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          208
      title
      Gleason Score 7-10
    description
    CS21A 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. Two of the participants did not have a Gleason Score at Baseline.
    param Type
    NUMBER
    title
    Gleason Score
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          114
      title
      Localised
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          132
      title
      Locally advanced
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          75
      title
      Metastatic
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          64
      title
      Not classifiable
    description
    CS21A ITT population. Prostate cancer stage was classified according to the Tumor, Nodes, and Metastatic (TNM) scale to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.
    param Type
    NUMBER
    title
    Stage of Prostate Cancer
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.28
          upper Limit
          10.6
          value
          4.63
        2. group Id
          BG001
          lower Limit
          0.55
          upper Limit
          10.6
          value
          4.02
        3. group Id
          BG002
          lower Limit
          1.34
          upper Limit
          12.5
          value
          4.32
        4. group Id
          BG003
          lower Limit
          0.37
          upper Limit
          8.00
          value
          3.51
        5. group Id
          BG004
          lower Limit
          0.37
          upper Limit
          12.5
          value
          4.23
    description
    CS21A ITT population.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Serum Testosterone Levels
    unit Of Measure
    nanograms per milliliter
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.70
          upper Limit
          3187
          value
          22.2
        2. group Id
          BG001
          lower Limit
          1.50
          upper Limit
          4902
          value
          22.5
        3. group Id
          BG002
          lower Limit
          1.60
          upper Limit
          2112
          value
          25.5
        4. group Id
          BG003
          lower Limit
          1.60
          upper Limit
          10952
          value
          14.0
        5. group Id
          BG004
          lower Limit
          1.50
          upper Limit
          10952
          value
          21.0
    description
    CS21A ITT population.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Serum Prostate-Specific Antigen (PSA) Levels
    unit Of Measure
    nanograms per milliliter
population Description
CS21A intention-to-treat (ITT) population.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      125
    2. group Id
      BG001
      value
      126
    3. group Id
      BG002
      value
      69
    4. group Id
      BG003
      value
      65
    5. group Id
      BG004
      value
      385
    units
    Participants
groups
  1. description
    The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
    id
    BG000
    title
    Degarelix 80 mg / Degarelix 80 mg
  2. description
    The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    id
    BG001
    title
    Degarelix 160 mg / Degarelix 160 mg
  3. description
    During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    id
    BG002
    title
    Leuprolide 7.5 mg / Degarelix 80 mg
  4. description
    During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    id
    BG003
    title
    Leuprolide 7.5 mg / Degarelix 160 mg
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.62
          value
          70.1
        2. group Id
          BG001
          spread
          8.25
          value
          71.1
        3. group Id
          BG002
          spread
          9.46
          value
          72.4
        4. group Id
          BG003
          spread
          8.24
          value
          71.4
        5. group Id
          BG004
          spread
          8.29
          value
          71.1
    description
    CS21A intention-to-treat (ITT) population.
    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
          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
        Female
      2. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          69
        4. group Id
          BG003
          value
          65
        5. group Id
          BG004
          value
          385
        title
        Male
    description
    CS21A ITT population.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          48
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          26
      title
      Hungary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          37
      title
      Czech Republic
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          49
      title
      Mexico
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          18
      title
      Canada
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          31
      title
      Ukraine
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          106
      title
      Romania
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          64
      title
      Russian Federation
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
      title
      Netherlands
    10. 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
      Germany
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
      title
      United Kingdom
    description
    CS21A ITT population.
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.6
          value
          78.4
        2. group Id
          BG001
          spread
          13.4
          value
          79.2
        3. group Id
          BG002
          spread
          11.3
          value
          78.7
        4. group Id
          BG003
          spread
          12.1
          value
          80.0
        5. group Id
          BG004
          spread
          12.5
          value
          79.0
    description
    CS21A ITT population.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Weight
    unit Of Measure
    kilogram
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.92
          value
          26.4
        2. group Id
          BG001
          spread
          3.79
          value
          26.9
        3. group Id
          BG002
          spread
          3.94
          value
          26.9
        4. group Id
          BG003
          spread
          3.67
          value
          27.1
        5. group Id
          BG004
          spread
          3.84
          value
          26.8
    description
    CS21A ITT population.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index
    unit Of Measure
    kilogram per square meter
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          51
      title
      Gleason Score 2-4
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          124
      title
      Gleason Score 5-6
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          208
      title
      Gleason Score 7-10
    description
    CS21A 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. Two of the participants did not have a Gleason Score at Baseline.
    param Type
    NUMBER
    title
    Gleason Score
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          114
      title
      Localised
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          132
      title
      Locally advanced
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          75
      title
      Metastatic
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          64
      title
      Not classifiable
    description
    CS21A ITT population. Prostate cancer stage was classified according to the Tumor, Nodes, and Metastatic (TNM) scale to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.
    param Type
    NUMBER
    title
    Stage of Prostate Cancer
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.28
          upper Limit
          10.6
          value
          4.63
        2. group Id
          BG001
          lower Limit
          0.55
          upper Limit
          10.6
          value
          4.02
        3. group Id
          BG002
          lower Limit
          1.34
          upper Limit
          12.5
          value
          4.32
        4. group Id
          BG003
          lower Limit
          0.37
          upper Limit
          8.00
          value
          3.51
        5. group Id
          BG004
          lower Limit
          0.37
          upper Limit
          12.5
          value
          4.23
    description
    CS21A ITT population.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Serum Testosterone Levels
    unit Of Measure
    nanograms per milliliter
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.70
          upper Limit
          3187
          value
          22.2
        2. group Id
          BG001
          lower Limit
          1.50
          upper Limit
          4902
          value
          22.5
        3. group Id
          BG002
          lower Limit
          1.60
          upper Limit
          2112
          value
          25.5
        4. group Id
          BG003
          lower Limit
          1.60
          upper Limit
          10952
          value
          14.0
        5. group Id
          BG004
          lower Limit
          1.50
          upper Limit
          10952
          value
          21.0
    description
    CS21A ITT population.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Serum Prostate-Specific Antigen (PSA) Levels
    unit Of Measure
    nanograms per milliliter
population Description
CS21A intention-to-treat (ITT) population.

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Preserved source evidence · Not medical advice