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NCT01673646 · OUTCOME

Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase)

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.

Measure
MEDIAN
Unit
ug/L
Interval / dispersion
Full Range
Time frame
Baselnine, Months 2.75, 3, 6, 9, 12, 18, 24

What was measured

This shows a change of mean GH levels and somatostatin analogues (SSAs) from baseline in extension phase

Analysis population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.

Groups in this outcome

SSA Uncontrolled

Somatostatin analogue (SSA) uncontrolled population composes of patients who were pre-treated with SSA for \>= 12 weeks.

Others

Patients who were pre-treated with SSA for \< 12 weeks or were not pre-treated with SSA are considered as others.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
SSA Uncontrolled20
Others13

Reported measurements

Month 2.75
Values in ug/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
SSA Uncontrolled-8.84Not reported-25.639.3Not reported
Others-6.62Not reported-157.2-1.4Not reported
Month 3
Values in ug/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
SSA Uncontrolled-6.71Not reported-22.239.3Not reported
Others-5.04Not reported-99.2-1.4Not reported
Month 6
Values in ug/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
SSA Uncontrolled-8.15Not reported-25.439.3Not reported
Others-6.35Not reported-149.8-1.4Not reported
Month 9
Values in ug/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
SSA Uncontrolled-9.02Not reported-24.639.3Not reported
Others-8.72Not reported-163.81.8Not reported
Month 12
Values in ug/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
SSA Uncontrolled-10.10Not reported-29.13.0Not reported
Others-7.29Not reported-159.2-1.4Not reported
Month 18
Values in ug/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
SSA Uncontrolled-8.88Not reported-23.939.3Not reported
Others-7.70Not reported-155.7-0.3Not reported
Month 24
Values in ug/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
SSA Uncontrolled-9.76Not reported-25.539.3Not reported
Others-6.80Not reported-32.8-1.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -25.6
        upper Limit
        39.3
        value
        -8.84
      2. group Id
        OG001
        lower Limit
        -157.2
        upper Limit
        -1.4
        value
        -6.62
    title
    Month 2.75
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -22.2
        upper Limit
        39.3
        value
        -6.71
      2. group Id
        OG001
        lower Limit
        -99.2
        upper Limit
        -1.4
        value
        -5.04
    title
    Month 3
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -25.4
        upper Limit
        39.3
        value
        -8.15
      2. group Id
        OG001
        lower Limit
        -149.8
        upper Limit
        -1.4
        value
        -6.35
    title
    Month 6
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -24.6
        upper Limit
        39.3
        value
        -9.02
      2. group Id
        OG001
        lower Limit
        -163.8
        upper Limit
        1.8
        value
        -8.72
    title
    Month 9
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -29.1
        upper Limit
        3.0
        value
        -10.10
      2. group Id
        OG001
        lower Limit
        -159.2
        upper Limit
        -1.4
        value
        -7.29
    title
    Month 12
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -23.9
        upper Limit
        39.3
        value
        -8.88
      2. group Id
        OG001
        lower Limit
        -155.7
        upper Limit
        -0.3
        value
        -7.70
    title
    Month 18
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -25.5
        upper Limit
        39.3
        value
        -9.76
      2. group Id
        OG001
        lower Limit
        -32.8
        upper Limit
        -1.4
        value
        -6.80
    title
    Month 24
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      13
    units
    Participants
description
This shows a change of mean GH levels and somatostatin analogues (SSAs) from baseline in extension phase
dispersion Type
Full Range
groups
  1. description
    Somatostatin analogue (SSA) uncontrolled population composes of patients who were pre-treated with SSA for \>= 12 weeks.
    id
    OG000
    title
    SSA Uncontrolled
  2. description
    Patients who were pre-treated with SSA for \< 12 weeks or were not pre-treated with SSA are considered as others.
    id
    OG001
    title
    Others
param Type
MEDIAN
population Description
FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.
reporting Status
POSTED
time Frame
Baselnine, Months 2.75, 3, 6, 9, 12, 18, 24
title
Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase)
type
SECONDARY
unit Of Measure
ug/L

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Preserved source evidence · Not medical advice