Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02200614 · FLOW

Participant flow

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.

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
    FG000
    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
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        86
      2. group Id
        FG001
        num Subjects
        48
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        120
      2. group Id
        FG001
        num Subjects
        140
      type
      Confirmed metastasis
    3. reasons
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        99
      type
      Judgment of the investigator
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Metastasis by local reading
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        2
      type
      Other reason
    6. reasons
      1. group Id
        FG000
        num Subjects
        77
      2. group Id
        FG001
        num Subjects
        85
      type
      Personal reason
    7. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        7
      type
      Protocol deviation
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Not treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        955
      2. group Id
        FG001
        num Subjects
        554
      comment
      Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        591
      2. group Id
        FG001
        num Subjects
        170
      comment
      Ongoing with treatment
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        364
      2. group Id
        FG001
        num Subjects
        384
      type
      NOT COMPLETED
    title
    Double Blind Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        11
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Confirmed metastasis
    3. reasons
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        2
      type
      Judgment of the investigator
    4. reasons
      1. group Id
        FG000
        num Subjects
        138
      2. group Id
        FG001
        num Subjects
        27
      type
      Metastasis by local reading
    5. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        4
      type
      Other reason
    6. reasons
      1. group Id
        FG000
        num Subjects
        60
      2. group Id
        FG001
        num Subjects
        8
      type
      Personal reason
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Protocol deviation
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Missing
    milestones
    1. achievements
      1. comment
        Not all participants from treatment period entered follow-up
        group Id
        FG000
        num Subjects
        591
      2. comment
        Not all participants from treatment period entered follow-up
        group Id
        FG001
        num Subjects
        170
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        295
      2. group Id
        FG001
        num Subjects
        114
      comment
      Moving to roll-over study
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        296
      2. group Id
        FG001
        num Subjects
        56
      type
      NOT COMPLETED
    title
    Open Label
pre Assignment Details
From 2696 participants who signed informed consent, 1187 participants were discontinued from screening. A total of 1509 participants were randomly assigned to either darolutamide arm or placebo arm. The study was unblinded on 30 OCT 2018 and participants in the placebo arm could cross over to open-label darolutamide treatment.
recruitment Details
Study was conducted at multiple centers in 36 countries between 12 September 2014 (first participant first visit) and 14 June 2021 (last participant last visit).
Complete source fields
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
    FG000
    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
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        86
      2. group Id
        FG001
        num Subjects
        48
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        120
      2. group Id
        FG001
        num Subjects
        140
      type
      Confirmed metastasis
    3. reasons
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        99
      type
      Judgment of the investigator
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Metastasis by local reading
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        2
      type
      Other reason
    6. reasons
      1. group Id
        FG000
        num Subjects
        77
      2. group Id
        FG001
        num Subjects
        85
      type
      Personal reason
    7. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        7
      type
      Protocol deviation
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Not treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        955
      2. group Id
        FG001
        num Subjects
        554
      comment
      Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        591
      2. group Id
        FG001
        num Subjects
        170
      comment
      Ongoing with treatment
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        364
      2. group Id
        FG001
        num Subjects
        384
      type
      NOT COMPLETED
    title
    Double Blind Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        11
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Confirmed metastasis
    3. reasons
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        2
      type
      Judgment of the investigator
    4. reasons
      1. group Id
        FG000
        num Subjects
        138
      2. group Id
        FG001
        num Subjects
        27
      type
      Metastasis by local reading
    5. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        4
      type
      Other reason
    6. reasons
      1. group Id
        FG000
        num Subjects
        60
      2. group Id
        FG001
        num Subjects
        8
      type
      Personal reason
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Protocol deviation
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Missing
    milestones
    1. achievements
      1. comment
        Not all participants from treatment period entered follow-up
        group Id
        FG000
        num Subjects
        591
      2. comment
        Not all participants from treatment period entered follow-up
        group Id
        FG001
        num Subjects
        170
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        295
      2. group Id
        FG001
        num Subjects
        114
      comment
      Moving to roll-over study
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        296
      2. group Id
        FG001
        num Subjects
        56
      type
      NOT COMPLETED
    title
    Open Label
pre Assignment Details
From 2696 participants who signed informed consent, 1187 participants were discontinued from screening. A total of 1509 participants were randomly assigned to either darolutamide arm or placebo arm. The study was unblinded on 30 OCT 2018 and participants in the placebo arm could cross over to open-label darolutamide treatment.
recruitment Details
Study was conducted at multiple centers in 36 countries between 12 September 2014 (first participant first visit) and 14 June 2021 (last participant last visit).

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

Preserved source evidence · Not medical advice