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NCT01212991 · BASELINE

Baseline characteristics

A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer · Source last updated 2020-03-17

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
      872
    2. group Id
      BG001
      value
      845
    3. group Id
      BG002
      value
      1717
    units
    Participants
groups
  1. description
    Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
    id
    BG000
    title
    Enzalutamide
  2. description
    Participants received placebo, administered as four capsules, once per day by mouth.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          179
        3. group Id
          BG002
          value
          358
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          693
        2. group Id
          BG001
          value
          666
        3. group Id
          BG002
          value
          1359
        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
          8.51
          value
          71.3
        2. group Id
          BG001
          spread
          8.42
          value
          71.2
        3. group Id
          BG002
          spread
          8.47
          value
          71.3
    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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          872
        2. group Id
          BG001
          value
          845
        3. group Id
          BG002
          value
          1717
        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
          127
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          247
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
      title
      Slovakia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          33
      title
      Finland
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          81
      title
      Spain
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
      title
      Lithuania
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          18
      title
      Austria
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          22
      title
      Russian Federation
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          25
      title
      Israel
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          153
      title
      United Kingdom
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          30
      title
      Italy
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          175
      title
      France
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          88
        3. group Id
          BG002
          value
          179
      title
      Canada
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    count of participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      872
    2. group Id
      BG001
      value
      845
    3. group Id
      BG002
      value
      1717
    units
    Participants
groups
  1. description
    Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
    id
    BG000
    title
    Enzalutamide
  2. description
    Participants received placebo, administered as four capsules, once per day by mouth.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          179
        3. group Id
          BG002
          value
          358
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          693
        2. group Id
          BG001
          value
          666
        3. group Id
          BG002
          value
          1359
        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
          8.51
          value
          71.3
        2. group Id
          BG001
          spread
          8.42
          value
          71.2
        3. group Id
          BG002
          spread
          8.47
          value
          71.3
    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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          872
        2. group Id
          BG001
          value
          845
        3. group Id
          BG002
          value
          1717
        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
          127
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          247
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
      title
      Slovakia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          33
      title
      Finland
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          81
      title
      Spain
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
      title
      Lithuania
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          18
      title
      Austria
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          22
      title
      Russian Federation
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          25
      title
      Israel
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          153
      title
      United Kingdom
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          30
      title
      Italy
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          175
      title
      France
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          88
        3. group Id
          BG002
          value
          179
      title
      Canada
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    count of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice