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NCT01673646 · BASELINE

Baseline characteristics

Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism · Source last updated 2019-09-16

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
      11
    2. group Id
      BG001
      value
      11
    3. group Id
      BG002
      value
      11
    4. group Id
      BG003
      value
      33
    units
    Participants
groups
  1. description
    Enrolled patients were randomized to 20mg pasireotide LAR.
    id
    BG000
    title
    Pasireotide LAR 20mg
  2. description
    Enrolled patients were randomized to 40mg pasireotide LAR.
    id
    BG001
    title
    Pasireotide LAR 40mg
  3. description
    Enrolled patients were randomized to 60mg pasireotide LAR.
    id
    BG002
    title
    Pasireotide LAR 60mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.48
          value
          57.2
        2. group Id
          BG001
          spread
          13.75
          value
          49.1
        3. group Id
          BG002
          spread
          14.60
          value
          46.6
        4. group Id
          BG003
          spread
          13.71
          value
          51.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Full analysis set comprises all patients to whom study treatment had been assigned by randomization.
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          20
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Full analysis set comprises all patients to whom study treatment had been assigned by randomization.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          33
      title
      Asian
    param Type
    NUMBER
    population Description
    Full analysis set comprises all patients to whom study treatment had been assigned by randomization.
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full analysis set comprises all patients to whom study treatment had been assigned by randomization.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      11
    2. group Id
      BG001
      value
      11
    3. group Id
      BG002
      value
      11
    4. group Id
      BG003
      value
      33
    units
    Participants
groups
  1. description
    Enrolled patients were randomized to 20mg pasireotide LAR.
    id
    BG000
    title
    Pasireotide LAR 20mg
  2. description
    Enrolled patients were randomized to 40mg pasireotide LAR.
    id
    BG001
    title
    Pasireotide LAR 40mg
  3. description
    Enrolled patients were randomized to 60mg pasireotide LAR.
    id
    BG002
    title
    Pasireotide LAR 60mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.48
          value
          57.2
        2. group Id
          BG001
          spread
          13.75
          value
          49.1
        3. group Id
          BG002
          spread
          14.60
          value
          46.6
        4. group Id
          BG003
          spread
          13.71
          value
          51.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Full analysis set comprises all patients to whom study treatment had been assigned by randomization.
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          20
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Full analysis set comprises all patients to whom study treatment had been assigned by randomization.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          33
      title
      Asian
    param Type
    NUMBER
    population Description
    Full analysis set comprises all patients to whom study treatment had been assigned by randomization.
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full analysis set comprises all patients to whom study treatment had been assigned by randomization.

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

Preserved source evidence · Not medical advice