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NCT02489318 · BASELINE

Baseline characteristics

A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC · Source last updated 2026-08-31

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
      527
    2. group Id
      BG001
      value
      525
    3. group Id
      BG002
      value
      1052
    units
    Participants
groups
  1. description
    Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    id
    BG000
    title
    Placebo + Androgen Deprivation Therapy (ADT)
  2. description
    Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    id
    BG001
    title
    Apalutamide + ADT
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.42
          value
          67.9
        2. group Id
          BG001
          spread
          8.11
          value
          68.9
        3. group Id
          BG002
          spread
          8.28
          value
          68.4
    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
          527
        2. group Id
          BG001
          value
          525
        3. group Id
          BG002
          value
          1052
        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
          11
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          17
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          119
        3. group Id
          BG002
          value
          231
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          365
        2. group Id
          BG001
          value
          354
        3. group Id
          BG002
          value
          719
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          65
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          37
      title
      ARGENTINA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
      title
      AUSTRALIA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          92
      title
      BRAZIL
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          30
      title
      CANADA
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          94
      title
      CHINA
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          31
      title
      CZECH REPUBLIC
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
      title
      FRANCE
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          17
      title
      GERMANY
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          24
      title
      HUNGARY
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
      title
      ISRAEL
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          34
      title
      ITALY
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          51
      title
      JAPAN
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          17
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          119
        3. group Id
          BG002
          value
          231
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      More than one race
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          19
      title
      Not Reported
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          46
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          365
        2. group Id
          BG001
          value
          354
        3. group Id
          BG002
          value
          719
      title
      White
    param Type
    NUMBER
    title
    Race (NIH/OMB)
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      527
    2. group Id
      BG001
      value
      525
    3. group Id
      BG002
      value
      1052
    units
    Participants
groups
  1. description
    Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    id
    BG000
    title
    Placebo + Androgen Deprivation Therapy (ADT)
  2. description
    Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    id
    BG001
    title
    Apalutamide + ADT
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.42
          value
          67.9
        2. group Id
          BG001
          spread
          8.11
          value
          68.9
        3. group Id
          BG002
          spread
          8.28
          value
          68.4
    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
          527
        2. group Id
          BG001
          value
          525
        3. group Id
          BG002
          value
          1052
        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
          11
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          17
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          119
        3. group Id
          BG002
          value
          231
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          365
        2. group Id
          BG001
          value
          354
        3. group Id
          BG002
          value
          719
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          65
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          37
      title
      ARGENTINA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
      title
      AUSTRALIA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          92
      title
      BRAZIL
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          30
      title
      CANADA
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          94
      title
      CHINA
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          31
      title
      CZECH REPUBLIC
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
      title
      FRANCE
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          17
      title
      GERMANY
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          24
      title
      HUNGARY
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
      title
      ISRAEL
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          34
      title
      ITALY
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          51
      title
      JAPAN
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          17
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          119
        3. group Id
          BG002
          value
          231
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      More than one race
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          19
      title
      Not Reported
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          46
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          365
        2. group Id
          BG001
          value
          354
        3. group Id
          BG002
          value
          719
      title
      White
    param Type
    NUMBER
    title
    Race (NIH/OMB)
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice