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NCT02200614 · BASELINE

Baseline characteristics

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer · Source last updated 2022-06-28

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
      955
    2. group Id
      BG001
      value
      554
    3. group Id
      BG002
      value
      1509
    units
    Participants
groups
  1. description
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
    id
    BG000
    title
    Darolutamide (BAY1841788)
  2. description
    Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
    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
          spread
          7.8
          value
          73.9
        2. group Id
          BG001
          spread
          8.2
          value
          73.2
        3. group Id
          BG002
          spread
          8.0
          value
          73.6
    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
          955
        2. group Id
          BG001
          value
          554
        3. group Id
          BG002
          value
          1509
        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
          122
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          193
        title
        Asia
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          52
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          760
        2. group Id
          BG001
          value
          434
        3. group Id
          BG002
          value
          1194
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          55
        title
        Missing
      5. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      955
    2. group Id
      BG001
      value
      554
    3. group Id
      BG002
      value
      1509
    units
    Participants
groups
  1. description
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
    id
    BG000
    title
    Darolutamide (BAY1841788)
  2. description
    Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
    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
          spread
          7.8
          value
          73.9
        2. group Id
          BG001
          spread
          8.2
          value
          73.2
        3. group Id
          BG002
          spread
          8.0
          value
          73.6
    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
          955
        2. group Id
          BG001
          value
          554
        3. group Id
          BG002
          value
          1509
        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
          122
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          193
        title
        Asia
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          52
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          760
        2. group Id
          BG001
          value
          434
        3. group Id
          BG002
          value
          1194
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          55
        title
        Missing
      5. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice