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NCT01715285 · BASELINE

Baseline characteristics

A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC) · Source last updated 2025-02-04

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
      597
    2. group Id
      BG001
      value
      602
    3. group Id
      BG002
      value
      1199
    units
    Participants
groups
  1. description
    Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
    id
    BG000
    title
    Abiraterone Acetate+Prednisone+ADT
  2. description
    Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
    id
    BG001
    title
    Placebo + ADT
  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
          221
        2. group Id
          BG001
          value
          233
        3. group Id
          BG002
          value
          454
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          376
        2. group Id
          BG001
          value
          369
        3. group Id
          BG002
          value
          745
        title
        >=65 years
      title
      <=18 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.48
          value
          67.3
        2. group Id
          BG001
          spread
          8.72
          value
          66.8
        3. group Id
          BG002
          spread
          8.6
          value
          67.1
    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
          597
        2. group Id
          BG001
          value
          602
        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
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
      title
      Argentina
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
      title
      Australia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
      title
      Belgium
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          56
      title
      Brazil
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Bulgaria
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          33
      title
      Canada
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      Chile
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          137
      title
      China
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          17
      title
      Colombia
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          16
      title
      Czech Republic
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          28
      title
      Denmark
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
      title
      Finland
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) analysis set included all participants randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received. .
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      597
    2. group Id
      BG001
      value
      602
    3. group Id
      BG002
      value
      1199
    units
    Participants
groups
  1. description
    Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
    id
    BG000
    title
    Abiraterone Acetate+Prednisone+ADT
  2. description
    Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
    id
    BG001
    title
    Placebo + ADT
  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
          221
        2. group Id
          BG001
          value
          233
        3. group Id
          BG002
          value
          454
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          376
        2. group Id
          BG001
          value
          369
        3. group Id
          BG002
          value
          745
        title
        >=65 years
      title
      <=18 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.48
          value
          67.3
        2. group Id
          BG001
          spread
          8.72
          value
          66.8
        3. group Id
          BG002
          spread
          8.6
          value
          67.1
    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
          597
        2. group Id
          BG001
          value
          602
        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
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
      title
      Argentina
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
      title
      Australia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
      title
      Belgium
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          56
      title
      Brazil
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Bulgaria
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          33
      title
      Canada
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      Chile
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          137
      title
      China
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          17
      title
      Colombia
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          16
      title
      Czech Republic
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          28
      title
      Denmark
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
      title
      Finland
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) analysis set included all participants randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received. .

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Preserved source evidence · Not medical advice