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NCT00958841 · FLOW

Participant flow

Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin · Source last updated 2016-07-26

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

groups
  1. description
    All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) \& Nelson's syndrome.
    id
    FG000
    title
    Pasireotide LAR 60mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Abnormal laboratory value(s)
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Abnormal test procedure result(s)
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Administrative problems
    4. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      New cancer therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        22
      type
      Unsatisfactory therapeutic effect
    8. reasons
      1. group Id
        FG000
        num Subjects
        27
      type
      Completed M6/did not enter extension
    9. reasons
      1. group Id
        FG000
        num Subjects
        28
      type
      Discontinued prior to M*
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        118
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        90
      type
      Completed Month 6 (M6)
    3. achievements
      1. group Id
        FG000
        num Subjects
        63
      type
      Entered in Extension
    4. achievements
      1. comment
        Completed = Completed extension
        group Id
        FG000
        num Subjects
        22
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        96
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.
Complete source fields
groups
  1. description
    All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) \& Nelson's syndrome.
    id
    FG000
    title
    Pasireotide LAR 60mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Abnormal laboratory value(s)
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Abnormal test procedure result(s)
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Administrative problems
    4. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      New cancer therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        22
      type
      Unsatisfactory therapeutic effect
    8. reasons
      1. group Id
        FG000
        num Subjects
        27
      type
      Completed M6/did not enter extension
    9. reasons
      1. group Id
        FG000
        num Subjects
        28
      type
      Discontinued prior to M*
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        118
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        90
      type
      Completed Month 6 (M6)
    3. achievements
      1. group Id
        FG000
        num Subjects
        63
      type
      Entered in Extension
    4. achievements
      1. comment
        Completed = Completed extension
        group Id
        FG000
        num Subjects
        22
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        96
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.

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Preserved source evidence · Not medical advice