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NCT02799602 · BASELINE

Baseline characteristics

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer · Source last updated 2025-12-04

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
      651
    2. group Id
      BG001
      value
      654
    3. group Id
      BG002
      value
      1305
    units
    Participants
groups
  1. description
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    id
    BG000
    title
    Darolutamide (BAY1841788) + Docetaxel
  2. description
    Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    id
    BG001
    title
    Placebo + Docetaxel
  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
          243
        2. group Id
          BG001
          value
          234
        3. group Id
          BG002
          value
          477
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          408
        2. group Id
          BG001
          value
          420
        3. group Id
          BG002
          value
          828
        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
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          651
        2. group Id
          BG001
          value
          654
        3. group Id
          BG002
          value
          1305
        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
          40
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          89
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          561
        2. group Id
          BG001
          value
          557
        3. group Id
          BG002
          value
          1118
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          98
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          231
        2. group Id
          BG001
          value
          245
        3. group Id
          BG002
          value
          476
        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
          26
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          54
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          345
        2. group Id
          BG001
          value
          333
        3. group Id
          BG002
          value
          678
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          89
        title
        Unknown or Not Reported
    description
    More than one race includes: "American Indian or Alaska Native", "Native Hawaiian or other Pacific Islander", and "Multiple"
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      651
    2. group Id
      BG001
      value
      654
    3. group Id
      BG002
      value
      1305
    units
    Participants
groups
  1. description
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    id
    BG000
    title
    Darolutamide (BAY1841788) + Docetaxel
  2. description
    Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    id
    BG001
    title
    Placebo + Docetaxel
  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
          243
        2. group Id
          BG001
          value
          234
        3. group Id
          BG002
          value
          477
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          408
        2. group Id
          BG001
          value
          420
        3. group Id
          BG002
          value
          828
        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
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          651
        2. group Id
          BG001
          value
          654
        3. group Id
          BG002
          value
          1305
        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
          40
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          89
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          561
        2. group Id
          BG001
          value
          557
        3. group Id
          BG002
          value
          1118
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          98
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          231
        2. group Id
          BG001
          value
          245
        3. group Id
          BG002
          value
          476
        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
          26
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          54
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          345
        2. group Id
          BG001
          value
          333
        3. group Id
          BG002
          value
          678
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          89
        title
        Unknown or Not Reported
    description
    More than one race includes: "American Indian or Alaska Native", "Native Hawaiian or other Pacific Islander", and "Multiple"
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice