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NCT00256698 · FLOW

Participant flow

Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy · Source last updated 2012-08-01

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

groups
  1. description
    Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
    id
    FG000
    title
    Fulvestrant + Anastrozole
  2. description
    Anastrozole 1 mg
    id
    FG001
    title
    Anastrozole
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        6
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        97
      2. group Id
        FG001
        num Subjects
        105
      type
      disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        46
      type
      still ongoing at data cut-off
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      withdrawn due to osteoporosis
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Prematurely Discontinued
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        258
      2. group Id
        FG001
        num Subjects
        256
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        91
      2. group Id
        FG001
        num Subjects
        84
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        167
      2. group Id
        FG001
        num Subjects
        172
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
258 patients were randomised to Fulvestrant + Anastrozole and 256 patients were randomised to Anastrozole. In each treatment group, there were 2 patients who did not receive any trial therapy and so have been excluded from the safety summaries.
Complete source fields
groups
  1. description
    Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
    id
    FG000
    title
    Fulvestrant + Anastrozole
  2. description
    Anastrozole 1 mg
    id
    FG001
    title
    Anastrozole
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        6
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        97
      2. group Id
        FG001
        num Subjects
        105
      type
      disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        46
      type
      still ongoing at data cut-off
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      withdrawn due to osteoporosis
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Prematurely Discontinued
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        258
      2. group Id
        FG001
        num Subjects
        256
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        91
      2. group Id
        FG001
        num Subjects
        84
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        167
      2. group Id
        FG001
        num Subjects
        172
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
258 patients were randomised to Fulvestrant + Anastrozole and 256 patients were randomised to Anastrozole. In each treatment group, there were 2 patients who did not receive any trial therapy and so have been excluded from the safety summaries.

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Preserved source evidence · Not medical advice