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NCT02003924 · BASELINE

Baseline characteristics

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer · Source last updated 2026-01-27

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
      933
    2. group Id
      BG001
      value
      468
    3. group Id
      BG002
      value
      1401
    units
    Participants
groups
  1. description
    Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
    id
    BG000
    title
    Enzalutamide 160 mg
  2. description
    Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    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
          spread
          7.83
          value
          73.8
        2. group Id
          BG001
          spread
          7.63
          value
          72.9
        3. group Id
          BG002
          spread
          7.77
          value
          73.5
    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
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          933
        2. group Id
          BG001
          value
          468
        3. group Id
          BG002
          value
          1401
        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
          142
        2. group Id
          BG001
          value
          88
        3. group Id
          BG002
          value
          230
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          31
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Native Hawaiian or Other Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          671
        2. group Id
          BG001
          value
          320
        3. group Id
          BG002
          value
          991
      title
      White
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
      title
      Multiple
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          20
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          116
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The intent-to-treat (ITT) population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      933
    2. group Id
      BG001
      value
      468
    3. group Id
      BG002
      value
      1401
    units
    Participants
groups
  1. description
    Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
    id
    BG000
    title
    Enzalutamide 160 mg
  2. description
    Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    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
          spread
          7.83
          value
          73.8
        2. group Id
          BG001
          spread
          7.63
          value
          72.9
        3. group Id
          BG002
          spread
          7.77
          value
          73.5
    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
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          933
        2. group Id
          BG001
          value
          468
        3. group Id
          BG002
          value
          1401
        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
          142
        2. group Id
          BG001
          value
          88
        3. group Id
          BG002
          value
          230
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          31
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Native Hawaiian or Other Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          671
        2. group Id
          BG001
          value
          320
        3. group Id
          BG002
          value
          991
      title
      White
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
      title
      Multiple
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          20
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          116
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The intent-to-treat (ITT) population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.

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

Preserved source evidence · Not medical advice