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NCT01137682 · FLOW

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Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly · Source last updated 2018-04-05

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

groups
  1. description
    Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
    id
    FG000
    title
    Pasireotide LAR 40 mg
  2. description
    Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
    id
    FG001
    title
    Pasireotide LAR 60 mg
  3. description
    Open label octreotide LAR 30 mg or lanreotide ATG 120 mg supplied either locally or from designated depot. Administered intramuscular every 28 days
    id
    FG002
    title
    Control Arm (Octreotide or Lanreotide)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event-CORE
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Withdrawal by Subject-CORE
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Administrative problems-CORE
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Protocol Violation-CORE
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        7
      type
      Adverse Event-Extension
    6. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        13
      type
      Lack of Efficacy-Extension
    7. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        8
      type
      Withdrawal by Subject-Extension
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow Up-Extension
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Administrative problems-Extension
    10. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death-Extension
    11. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation-Extension
    12. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      type
      Did not enter extension
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        65
      3. group Id
        FG002
        num Subjects
        68
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Not Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        63
      2. group Id
        FG001
        num Subjects
        63
      3. group Id
        FG002
        num Subjects
        67
      type
      Treated
    4. achievements
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        57
      3. group Id
        FG002
        num Subjects
        65
      type
      Completed 24-Week Core Phase
    5. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      type
      Not Continuing Into Extension
    6. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        54
      3. group Id
        FG002
        num Subjects
        63
      type
      Continuing Into Extension
    7. achievements
      1. comment
        2 patients never received drug.
        group Id
        FG000
        num Subjects
        63
      2. comment
        2 patients never received drug. 1 patient had no post baseline safety assement.
        group Id
        FG001
        num Subjects
        62
      3. comment
        2 patients never received drug.
        group Id
        FG002
        num Subjects
        66
      type
      Safety Set - CORE
    8. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        54
      3. comment
        1 patient did not receive study treatment
        group Id
        FG002
        num Subjects
        62
      type
      Safety Set - Extension
    9. achievements
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        34
      type
      COMPLETED
    10. achievements
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        34
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
One hundred ninety-eight patients were randomized and 5 patients in CORE and 1 patient in extension did not receive any study treatment
Complete source fields
groups
  1. description
    Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
    id
    FG000
    title
    Pasireotide LAR 40 mg
  2. description
    Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
    id
    FG001
    title
    Pasireotide LAR 60 mg
  3. description
    Open label octreotide LAR 30 mg or lanreotide ATG 120 mg supplied either locally or from designated depot. Administered intramuscular every 28 days
    id
    FG002
    title
    Control Arm (Octreotide or Lanreotide)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event-CORE
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Withdrawal by Subject-CORE
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Administrative problems-CORE
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Protocol Violation-CORE
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        7
      type
      Adverse Event-Extension
    6. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        13
      type
      Lack of Efficacy-Extension
    7. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        8
      type
      Withdrawal by Subject-Extension
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow Up-Extension
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Administrative problems-Extension
    10. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death-Extension
    11. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation-Extension
    12. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      type
      Did not enter extension
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        65
      3. group Id
        FG002
        num Subjects
        68
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Not Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        63
      2. group Id
        FG001
        num Subjects
        63
      3. group Id
        FG002
        num Subjects
        67
      type
      Treated
    4. achievements
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        57
      3. group Id
        FG002
        num Subjects
        65
      type
      Completed 24-Week Core Phase
    5. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      type
      Not Continuing Into Extension
    6. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        54
      3. group Id
        FG002
        num Subjects
        63
      type
      Continuing Into Extension
    7. achievements
      1. comment
        2 patients never received drug.
        group Id
        FG000
        num Subjects
        63
      2. comment
        2 patients never received drug. 1 patient had no post baseline safety assement.
        group Id
        FG001
        num Subjects
        62
      3. comment
        2 patients never received drug.
        group Id
        FG002
        num Subjects
        66
      type
      Safety Set - CORE
    8. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        54
      3. comment
        1 patient did not receive study treatment
        group Id
        FG002
        num Subjects
        62
      type
      Safety Set - Extension
    9. achievements
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        34
      type
      COMPLETED
    10. achievements
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        34
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
One hundred ninety-eight patients were randomized and 5 patients in CORE and 1 patient in extension did not receive any study treatment

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Preserved source evidence · Not medical advice