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NCT04497844 · BASELINE

Baseline characteristics

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) · Source last updated 2026-08-20

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
      348
    2. group Id
      BG001
      value
      348
    3. group Id
      BG002
      value
      696
    units
    Participants
groups
  1. description
    Participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration- sensitive prostate cancer (mCSPC) were randomized to receive placebo matching to niraparib and abiraterone acetate (AA) fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
    id
    BG000
    title
    Placebo With Abiraterone Acetate Plus Prednisone
  2. description
    Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
    id
    BG001
    title
    Niraparib With Abiraterone Acetate Plus Prednisone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.84
          value
          66.7
        2. group Id
          BG001
          spread
          8.75
          value
          67.8
        3. group Id
          BG002
          spread
          8.81
          value
          67.3
    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
          348
        2. group Id
          BG001
          value
          348
        3. group Id
          BG002
          value
          696
        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
          43
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          83
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          292
        2. group Id
          BG001
          value
          287
        3. group Id
          BG002
          value
          579
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          34
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          144
        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
          10
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          28
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          257
        2. group Id
          BG001
          value
          246
        3. group Id
          BG002
          value
          503
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          135
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          251
      title
      Adults (18-64 years)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          212
        2. group Id
          BG001
          value
          227
        3. group Id
          BG002
          value
          439
      title
      From 65 to 84 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
      title
      85 years and over
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          30
      title
      ARGENTINA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          23
      title
      AUSTRALIA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
      title
      BELARUS
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
      title
      BELGIUM
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          58
      title
      BRAZIL
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      BULGARIA
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          29
      title
      CANADA
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          53
      title
      CHINA
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      title
      CZECH REPUBLIC
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
      title
      DENMARK
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          32
      title
      FRANCE
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
      title
      GERMANY
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      348
    2. group Id
      BG001
      value
      348
    3. group Id
      BG002
      value
      696
    units
    Participants
groups
  1. description
    Participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration- sensitive prostate cancer (mCSPC) were randomized to receive placebo matching to niraparib and abiraterone acetate (AA) fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
    id
    BG000
    title
    Placebo With Abiraterone Acetate Plus Prednisone
  2. description
    Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.
    id
    BG001
    title
    Niraparib With Abiraterone Acetate Plus Prednisone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.84
          value
          66.7
        2. group Id
          BG001
          spread
          8.75
          value
          67.8
        3. group Id
          BG002
          spread
          8.81
          value
          67.3
    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
          348
        2. group Id
          BG001
          value
          348
        3. group Id
          BG002
          value
          696
        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
          43
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          83
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          292
        2. group Id
          BG001
          value
          287
        3. group Id
          BG002
          value
          579
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          34
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          144
        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
          10
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          28
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          257
        2. group Id
          BG001
          value
          246
        3. group Id
          BG002
          value
          503
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          135
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          251
      title
      Adults (18-64 years)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          212
        2. group Id
          BG001
          value
          227
        3. group Id
          BG002
          value
          439
      title
      From 65 to 84 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
      title
      85 years and over
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          30
      title
      ARGENTINA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          23
      title
      AUSTRALIA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
      title
      BELARUS
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
      title
      BELGIUM
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          58
      title
      BRAZIL
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      BULGARIA
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          29
      title
      CANADA
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          53
      title
      CHINA
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      title
      CZECH REPUBLIC
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
      title
      DENMARK
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          32
      title
      FRANCE
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
      title
      GERMANY
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice