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NCT00974311 · BASELINE

Baseline characteristics

Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy · Source last updated 2018-12-11

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
      800
    2. group Id
      BG001
      value
      399
    3. group Id
      BG002
      value
      1199
    units
    Participants
groups
  1. description
    In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).
    id
    BG000
    title
    Enzalutamide
  2. description
    In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase).
    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
          232
        2. group Id
          BG001
          value
          130
        3. group Id
          BG002
          value
          362
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          568
        2. group Id
          BG001
          value
          269
        3. group Id
          BG002
          value
          837
        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
          7.96
          value
          68.8
        2. group Id
          BG001
          spread
          8.39
          value
          68.6
        3. group Id
          BG002
          spread
          8.11
          value
          68.7
    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
          800
        2. group Id
          BG001
          value
          399
        3. group Id
          BG002
          value
          1199
        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
          32
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          55
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          768
        2. group Id
          BG001
          value
          376
        3. group Id
          BG002
          value
          1144
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          13
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          47
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          745
        2. group Id
          BG001
          value
          366
        3. group Id
          BG002
          value
          1111
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          25
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          181
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          288
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          36
      title
      Spain
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          25
      title
      Austria
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
      title
      Chile
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          132
      title
      United Kingdom
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          30
      title
      Italy
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          193
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          273
      title
      France
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          107
      title
      Canada
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
      title
      Argentina
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          45
      title
      Belgium
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
      title
      Poland
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          93
      title
      Australia
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Intent-to-treat population (ITT) included all participants who were randomized into the study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      800
    2. group Id
      BG001
      value
      399
    3. group Id
      BG002
      value
      1199
    units
    Participants
groups
  1. description
    In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).
    id
    BG000
    title
    Enzalutamide
  2. description
    In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase).
    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
          232
        2. group Id
          BG001
          value
          130
        3. group Id
          BG002
          value
          362
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          568
        2. group Id
          BG001
          value
          269
        3. group Id
          BG002
          value
          837
        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
          7.96
          value
          68.8
        2. group Id
          BG001
          spread
          8.39
          value
          68.6
        3. group Id
          BG002
          spread
          8.11
          value
          68.7
    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
          800
        2. group Id
          BG001
          value
          399
        3. group Id
          BG002
          value
          1199
        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
          32
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          55
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          768
        2. group Id
          BG001
          value
          376
        3. group Id
          BG002
          value
          1144
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          13
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          47
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          745
        2. group Id
          BG001
          value
          366
        3. group Id
          BG002
          value
          1111
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          25
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          181
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          288
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          36
      title
      Spain
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          25
      title
      Austria
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
      title
      Chile
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          132
      title
      United Kingdom
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          30
      title
      Italy
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          193
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          273
      title
      France
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          107
      title
      Canada
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
      title
      Argentina
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          45
      title
      Belgium
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
      title
      Poland
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          93
      title
      Australia
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Intent-to-treat population (ITT) included all participants who were randomized into the study.

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Preserved source evidence · Not medical advice