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NCT02354508 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      41
    2. group Id
      BG001
      value
      29
    3. group Id
      BG002
      value
      53
    4. group Id
      BG003
      value
      123
    units
    Participants
groups
  1. description
    Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
    id
    BG000
    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
    BG001
    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
    BG002
    title
    Octreotide 40 mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.02
          value
          41.8
        2. group Id
          BG001
          spread
          12.89
          value
          41.6
        3. group Id
          BG002
          spread
          11.63
          value
          46.6
        4. group Id
          BG003
          spread
          11.60
          value
          43.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          62
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          61
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          78
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          11
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          30
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS): comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      41
    2. group Id
      BG001
      value
      29
    3. group Id
      BG002
      value
      53
    4. group Id
      BG003
      value
      123
    units
    Participants
groups
  1. description
    Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
    id
    BG000
    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
    BG001
    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
    BG002
    title
    Octreotide 40 mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.02
          value
          41.8
        2. group Id
          BG001
          spread
          12.89
          value
          41.6
        3. group Id
          BG002
          spread
          11.63
          value
          46.6
        4. group Id
          BG003
          spread
          11.60
          value
          43.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          62
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          61
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          78
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          11
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          30
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS): comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.

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Preserved source evidence · Not medical advice