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NCT00887198 · FLOW

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Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer · Source last updated 2025-02-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4\*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
    id
    FG000
    title
    Abiraterone Acetate + Prednisone (AAP)
  2. description
    Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
    id
    FG001
    title
    Placebo
  3. description
    Participants who were originally assigned to placebo were later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4\*250 mg tablets) along with prednisone 5 mg tablet.
    id
    FG002
    title
    Placebo to AA
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Ongoing
    2. reasons
      1. group Id
        FG000
        num Subjects
        50
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        51
      3. group Id
        FG002
        num Subjects
        0
      type
      Cross-over to AA (under amendment 3)
    5. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        56
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        366
      2. group Id
        FG001
        num Subjects
        370
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    8. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Randomized, Not treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        546
      2. group Id
        FG001
        num Subjects
        542
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        542
      2. group Id
        FG001
        num Subjects
        540
      3. group Id
        FG002
        num Subjects
        0
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        546
      2. group Id
        FG001
        num Subjects
        542
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Randomized Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        8
      type
      Started other prostate cancer treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        35
      type
      Ongoing
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        20
      type
      Progressive disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        19
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. comment
        93= 51 participants(crossed over under amendment 3)+42 participants (crossed over under amendment 4)
        group Id
        FG002
        num Subjects
        93
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        93
      type
      NOT COMPLETED
    title
    Cross Over (Placebo to AA)
Complete source fields
groups
  1. description
    Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4\*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
    id
    FG000
    title
    Abiraterone Acetate + Prednisone (AAP)
  2. description
    Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
    id
    FG001
    title
    Placebo
  3. description
    Participants who were originally assigned to placebo were later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4\*250 mg tablets) along with prednisone 5 mg tablet.
    id
    FG002
    title
    Placebo to AA
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Ongoing
    2. reasons
      1. group Id
        FG000
        num Subjects
        50
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        51
      3. group Id
        FG002
        num Subjects
        0
      type
      Cross-over to AA (under amendment 3)
    5. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        56
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        366
      2. group Id
        FG001
        num Subjects
        370
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    8. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Randomized, Not treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        546
      2. group Id
        FG001
        num Subjects
        542
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        542
      2. group Id
        FG001
        num Subjects
        540
      3. group Id
        FG002
        num Subjects
        0
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        546
      2. group Id
        FG001
        num Subjects
        542
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Randomized Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        8
      type
      Started other prostate cancer treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        35
      type
      Ongoing
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        9
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        20
      type
      Progressive disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        19
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. comment
        93= 51 participants(crossed over under amendment 3)+42 participants (crossed over under amendment 4)
        group Id
        FG002
        num Subjects
        93
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        93
      type
      NOT COMPLETED
    title
    Cross Over (Placebo to AA)

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Preserved source evidence · Not medical advice