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NCT01137682 · OUTCOME

Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set)

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.

Measure
MEAN
Unit
mcg/L
Interval / dispersion
Standard Deviation
Time frame
CORE baseline up to approximately 24 weeks

What was measured

Standardized IGF-1 = IGF-1 value / ULN, where ULN is the upper limit of the normal range

Analysis population: Available data for analysis varies from visit to visit

Groups in this outcome

Pasireotide LAR 40 mg

Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days

Pasireotide LAR 60 mg

Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days

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

Analysis denominator · Participants

GroupSource count
Pasireotide LAR 40 mg57
Pasireotide LAR 60 mg54

Reported measurements

CORE Week 12

Analysis denominator · Participants

GroupSource count
Pasireotide LAR 40 mg57
Pasireotide LAR 60 mg53
Values in mcg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg0.70.97Not reportedNot reportedNot reported
Pasireotide LAR 60 mg-1.11.03Not reportedNot reportedNot reported
CORE Week 24

Analysis denominator · Participants

GroupSource count
Pasireotide LAR 40 mg56
Pasireotide LAR 60 mg49
Values in mcg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg-0.70.97Not reportedNot reportedNot reported
Pasireotide LAR 60 mg-1.11.12Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.97
        value
        0.7
      2. group Id
        OG001
        spread
        1.03
        value
        -1.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        53
      units
      Participants
    title
    CORE Week 12
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.97
        value
        -0.7
      2. group Id
        OG001
        spread
        1.12
        value
        -1.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        49
      units
      Participants
    title
    CORE Week 24
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    2. group Id
      OG001
      value
      54
    units
    Participants
description
Standardized IGF-1 = IGF-1 value / ULN, where ULN is the upper limit of the normal range
dispersion Type
Standard Deviation
groups
  1. description
    Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days
    id
    OG000
    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) for intramuscular administration every 28 days
    id
    OG001
    title
    Pasireotide LAR 60 mg
param Type
MEAN
population Description
Available data for analysis varies from visit to visit
reporting Status
POSTED
time Frame
CORE baseline up to approximately 24 weeks
title
Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set)
type
SECONDARY
unit Of Measure
mcg/L

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

Preserved source evidence · Not medical advice