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NCT01137682 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      65
    2. group Id
      BG001
      value
      65
    3. group Id
      BG002
      value
      68
    4. group Id
      BG003
      value
      198
    units
    Participants
groups
  1. description
    Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
    id
    BG000
    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)
    id
    BG001
    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
    BG002
    title
    Control Arm (Octreotide or Lanreotide)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          63
        4. group Id
          BG003
          value
          182
      title
      <65 Years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          16
      title
      ≥ 65 Years
    description
    CORE Period
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          111
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          87
        title
        Male
    description
    CORE Period
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          56
        4. group Id
          BG003
          value
          161
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          15
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          14
      title
      Other
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
      title
      Asian
    description
    CORE Period
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      65
    2. group Id
      BG001
      value
      65
    3. group Id
      BG002
      value
      68
    4. group Id
      BG003
      value
      198
    units
    Participants
groups
  1. description
    Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
    id
    BG000
    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)
    id
    BG001
    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
    BG002
    title
    Control Arm (Octreotide or Lanreotide)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          63
        4. group Id
          BG003
          value
          182
      title
      <65 Years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          16
      title
      ≥ 65 Years
    description
    CORE Period
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          111
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          87
        title
        Male
    description
    CORE Period
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          56
        4. group Id
          BG003
          value
          161
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          15
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          14
      title
      Other
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
      title
      Asian
    description
    CORE Period
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice