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NCT01288911 · BASELINE

Baseline characteristics

A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer · Source last updated 2024-12-06

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
      184
    2. group Id
      BG001
      value
      191
    3. group Id
      BG002
      value
      375
    units
    Participants
groups
  1. description
    Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
    id
    BG000
    title
    Enzalutamide
  2. description
    Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
    id
    BG001
    title
    Bicalutamide
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.22
          value
          70.3
        2. group Id
          BG001
          spread
          8.89
          value
          71.1
        3. group Id
          BG002
          spread
          9.05
          value
          70.7
    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
          45
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          92
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          165
      title
      65-75 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          118
      title
      > 75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  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
          184
        2. group Id
          BG001
          value
          191
        3. group Id
          BG002
          value
          375
        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
          172
        2. group Id
          BG001
          value
          176
        3. group Id
          BG002
          value
          348
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          18
      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
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Native Hawaiian or Other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          184
        2. group Id
          BG001
          value
          187
        3. group Id
          BG002
          value
          371
        title
        Not Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        title
        Hispanic or Latino
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          163
        title
        Before diagnosis of metastasis
      2. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          212
        title
        After diagnosis of metastasis
    param Type
    COUNT_OF_PARTICIPANTS
    title
    LHRH agonist/antagonist initiation or bilateral orchiectomy relative to diagnosis of metastasis
    unit Of Measure
    Participants
population Description
The baseline analysis population consisted of all participants that were randomized to receive study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      184
    2. group Id
      BG001
      value
      191
    3. group Id
      BG002
      value
      375
    units
    Participants
groups
  1. description
    Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
    id
    BG000
    title
    Enzalutamide
  2. description
    Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
    id
    BG001
    title
    Bicalutamide
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.22
          value
          70.3
        2. group Id
          BG001
          spread
          8.89
          value
          71.1
        3. group Id
          BG002
          spread
          9.05
          value
          70.7
    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
          45
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          92
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          165
      title
      65-75 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          118
      title
      > 75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  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
          184
        2. group Id
          BG001
          value
          191
        3. group Id
          BG002
          value
          375
        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
          172
        2. group Id
          BG001
          value
          176
        3. group Id
          BG002
          value
          348
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          18
      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
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Native Hawaiian or Other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          184
        2. group Id
          BG001
          value
          187
        3. group Id
          BG002
          value
          371
        title
        Not Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        title
        Hispanic or Latino
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          163
        title
        Before diagnosis of metastasis
      2. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          212
        title
        After diagnosis of metastasis
    param Type
    COUNT_OF_PARTICIPANTS
    title
    LHRH agonist/antagonist initiation or bilateral orchiectomy relative to diagnosis of metastasis
    unit Of Measure
    Participants
population Description
The baseline analysis population consisted of all participants that were randomized to receive study drug.

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

Preserved source evidence · Not medical advice