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NCT00790400 · FLOW

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Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) · Source last updated 2017-02-17

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

groups
  1. description
    Study drug was given by continuous oral daily dosing of two 5 mg tablets.
    id
    FG000
    title
    Everolimus
  2. description
    Placebo was given by continuous oral daily dosing of two 5 mg tablets.
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Violation
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        9
      type
      Progressive disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Abnormal lab value (s)
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Administrative problems
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. comment
        Completed = Completed the Core phase \& moved to Extension phase
        group Id
        FG000
        num Subjects
        72
      2. comment
        Completed = 1st received Placebo in the Core phase, switched to Everolimus in Extension phase
        group Id
        FG001
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        13
      type
      NOT COMPLETED
    title
    Double-blind Period (Core Phase)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Abnormal lab value (s)
    3. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Administrative problems
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease progression
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Violation
    9. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      New treatment
    milestones
    1. achievements
      1. comment
        112 pts had Everolimus during core and/or extension (6 from placebo did not switch to Eve. in ext.)
        group Id
        FG000
        num Subjects
        112
      2. comment
        Placebo randomized patients who switched to Everolimus are reported in "Everolimus" arm.
        group Id
        FG001
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. comment
        Treatment duration completed as per protocol
        group Id
        FG000
        num Subjects
        83
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Everolimus Period (Core or Extension)
pre Assignment Details
The trial had a 2:1 randomization in favor of the everolimus arm. 118 patients were randomized to the core phase of the study. 112 patients received everolimus during core and/or extension phase.
recruitment Details
A multicenter trial conducted at 24 sites in 11 countries. As the primary analysis of the core phase of the study favored everolimus over placebo, an open-label extension phase started: patients randomized in placebo were offered to switch on everolimus and those still receiving everolimus at the end of the core phase could continue the treatment.
Complete source fields
groups
  1. description
    Study drug was given by continuous oral daily dosing of two 5 mg tablets.
    id
    FG000
    title
    Everolimus
  2. description
    Placebo was given by continuous oral daily dosing of two 5 mg tablets.
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Violation
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        9
      type
      Progressive disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Abnormal lab value (s)
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Administrative problems
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. comment
        Completed = Completed the Core phase \& moved to Extension phase
        group Id
        FG000
        num Subjects
        72
      2. comment
        Completed = 1st received Placebo in the Core phase, switched to Everolimus in Extension phase
        group Id
        FG001
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        13
      type
      NOT COMPLETED
    title
    Double-blind Period (Core Phase)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Abnormal lab value (s)
    3. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Administrative problems
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease progression
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Violation
    9. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      New treatment
    milestones
    1. achievements
      1. comment
        112 pts had Everolimus during core and/or extension (6 from placebo did not switch to Eve. in ext.)
        group Id
        FG000
        num Subjects
        112
      2. comment
        Placebo randomized patients who switched to Everolimus are reported in "Everolimus" arm.
        group Id
        FG001
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. comment
        Treatment duration completed as per protocol
        group Id
        FG000
        num Subjects
        83
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Everolimus Period (Core or Extension)
pre Assignment Details
The trial had a 2:1 randomization in favor of the everolimus arm. 118 patients were randomized to the core phase of the study. 112 patients received everolimus during core and/or extension phase.
recruitment Details
A multicenter trial conducted at 24 sites in 11 countries. As the primary analysis of the core phase of the study favored everolimus over placebo, an open-label extension phase started: patients randomized in placebo were offered to switch on everolimus and those still receiving everolimus at the end of the core phase could continue the treatment.

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

Preserved source evidence · Not medical advice