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NCT02354508 · FLOW

Participant flow

Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues · Source last updated 2019-12-10

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

groups
  1. description
    Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
    id
    FG000
    title
    Lanreotide 120 mg
  2. description
    Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
    id
    FG001
    title
    Octreotide 30 mg
  3. description
    Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).
    id
    FG002
    title
    Octreotide 40 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Unsatisfactory therapeutic effect
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        29
      3. group Id
        FG002
        num Subjects
        53
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        47
      comment
      Completed 36 week (wk) Core phase
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Period 1: Core Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      type
      Unsatisfactory therapeutic effect
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. comment
        not all patients who completed the Core phase went into the Extension phase
        group Id
        FG000
        num Subjects
        26
      2. comment
        not all patients who completed the Core phase went into the Extension phase
        group Id
        FG001
        num Subjects
        23
      3. comment
        not all patients who completed the Core phase went into the Extension phase
        group Id
        FG002
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        36
      comment
      Completed 72 week extension phase
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Period 2: Extension Phase
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Unsatisfactory therapeutic effect
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        39
      comment
      Entered post-treatment follow up
      type
      STARTED
    2. achievements
      1. comment
        Entered post-treatment follow-up, discontinued
        group Id
        FG000
        num Subjects
        4
      2. comment
        Entered post-treatment follow-up, discontinued
        group Id
        FG001
        num Subjects
        3
      3. comment
        Entered post-treatment follow-up, discontinued
        group Id
        FG002
        num Subjects
        3
      type
      Entered Post-treatment f/up Discontinued
    3. achievements
      1. comment
        Entered post-treatment follow-up, completed
        group Id
        FG000
        num Subjects
        22
      2. comment
        Entered post-treatment follow-up, completed
        group Id
        FG001
        num Subjects
        20
      3. comment
        Entered post-treatment follow-up, completed
        group Id
        FG002
        num Subjects
        36
      comment
      Entered post-treatment follow-up, completed
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Period 3: Post-treatment Follow up Phase
pre Assignment Details
Participants were allocated to Group 1 or Group 2 based on previously received first generation Somatostatin analog (SSA).
recruitment Details
Planned 112 participants and analyzed 123 participants. For Participant Flow/Baseline Characteristics Tables, Total = Participants in the Pasireotide LAR arm.
Complete source fields
groups
  1. description
    Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
    id
    FG000
    title
    Lanreotide 120 mg
  2. description
    Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
    id
    FG001
    title
    Octreotide 30 mg
  3. description
    Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).
    id
    FG002
    title
    Octreotide 40 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Unsatisfactory therapeutic effect
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        29
      3. group Id
        FG002
        num Subjects
        53
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        47
      comment
      Completed 36 week (wk) Core phase
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Period 1: Core Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      type
      Unsatisfactory therapeutic effect
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. comment
        not all patients who completed the Core phase went into the Extension phase
        group Id
        FG000
        num Subjects
        26
      2. comment
        not all patients who completed the Core phase went into the Extension phase
        group Id
        FG001
        num Subjects
        23
      3. comment
        not all patients who completed the Core phase went into the Extension phase
        group Id
        FG002
        num Subjects
        39
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        36
      comment
      Completed 72 week extension phase
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Period 2: Extension Phase
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Unsatisfactory therapeutic effect
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        39
      comment
      Entered post-treatment follow up
      type
      STARTED
    2. achievements
      1. comment
        Entered post-treatment follow-up, discontinued
        group Id
        FG000
        num Subjects
        4
      2. comment
        Entered post-treatment follow-up, discontinued
        group Id
        FG001
        num Subjects
        3
      3. comment
        Entered post-treatment follow-up, discontinued
        group Id
        FG002
        num Subjects
        3
      type
      Entered Post-treatment f/up Discontinued
    3. achievements
      1. comment
        Entered post-treatment follow-up, completed
        group Id
        FG000
        num Subjects
        22
      2. comment
        Entered post-treatment follow-up, completed
        group Id
        FG001
        num Subjects
        20
      3. comment
        Entered post-treatment follow-up, completed
        group Id
        FG002
        num Subjects
        36
      comment
      Entered post-treatment follow-up, completed
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Period 3: Post-treatment Follow up Phase
pre Assignment Details
Participants were allocated to Group 1 or Group 2 based on previously received first generation Somatostatin analog (SSA).
recruitment Details
Planned 112 participants and analyzed 123 participants. For Participant Flow/Baseline Characteristics Tables, Total = Participants in the Pasireotide LAR arm.

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Preserved source evidence · Not medical advice