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NCT02354508 · OUTCOME

Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36

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.

Measure
MEAN
Unit
percentage change
Interval / dispersion
Standard Deviation
Time frame
Baseline, week 36

What was measured

Core phase - Changes in mean GH from study baseline to week 36.

Analysis population: 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.

Groups in this outcome

Lanreotide 120 mg

Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).

Octreotide 30 mg

Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .

Octreotide 40 mg

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).

Pasireotide LAR Overall

This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

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

Analysis denominator · Participants

GroupSource count
Lanreotide 120 mg41
Octreotide 30 mg29
Octreotide 40 mg53
Pasireotide LAR Overall123

Reported measurements

Source class 1
Values in percentage change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lanreotide 120 mg-7.719.51Not reportedNot reportedNot reported
Octreotide 30 mg-8.524.41Not reportedNot reportedNot reported
Octreotide 40 mg-2.94.21Not reportedNot reportedNot reported
Pasireotide LAR Overall-6.017.10Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.51
        value
        -7.7
      2. group Id
        OG001
        spread
        24.41
        value
        -8.5
      3. group Id
        OG002
        spread
        4.21
        value
        -2.9
      4. group Id
        OG003
        spread
        17.10
        value
        -6.0
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      29
    3. group Id
      OG002
      value
      53
    4. group Id
      OG003
      value
      123
    units
    Participants
description
Core phase - Changes in mean GH from study baseline to week 36.
dispersion Type
Standard Deviation
groups
  1. description
    Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
    id
    OG000
    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
    OG001
    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
    OG002
    title
    Octreotide 40 mg
  4. description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
    id
    OG003
    title
    Pasireotide LAR Overall
param Type
MEAN
population Description
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.
reporting Status
POSTED
time Frame
Baseline, week 36
title
Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36
type
SECONDARY
unit Of Measure
percentage change

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

Preserved source evidence · Not medical advice