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NCT02354508 · OUTCOME

Extension Phase: Percentage of Participants With Mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 & 72 (Up-titrated to Pasireotide LAR 60 mg)

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Weeks 48, 60 & 72

What was measured

Percentage of patients achieving IGF-1 \<ULN at weeks 48, 60 \& 72 for participants with up-titrated to Pasireotide LAR 60 mg mg

Analysis population: Extension Full Analysis Set (Extension FAS) included all the patients who received at least one dose of pasireotide LAR in the extension phase.

Groups in this outcome

Up-titrated to Pasireotide LAR 60 mg

This is the subset of participants in the FAS who started treatment with 40 mg pasireotide LAR in the core phase and were up-titrated to pasireotide LAR 60 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
Up-titrated to Pasireotide LAR 60 mg70

Reported measurements

Week 48
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Up-titrated to Pasireotide LAR 60 mg5.8Not reported1.6014.18Not reported
Week 60
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Up-titrated to Pasireotide LAR 60 mg7.1Not reported2.3615.89Not reported
Week 72
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Up-titrated to Pasireotide LAR 60 mg5.7Not reported1.5813.99Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.60
        upper Limit
        14.18
        value
        5.8
    title
    Week 48
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.36
        upper Limit
        15.89
        value
        7.1
    title
    Week 60
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.58
        upper Limit
        13.99
        value
        5.7
    title
    Week 72
denoms
  1. counts
    1. group Id
      OG000
      value
      70
    units
    Participants
description
Percentage of patients achieving IGF-1 \<ULN at weeks 48, 60 \& 72 for participants with up-titrated to Pasireotide LAR 60 mg mg
dispersion Type
95% Confidence Interval
groups
  1. description
    This is the subset of participants in the FAS who started treatment with 40 mg pasireotide LAR in the core phase and were up-titrated to pasireotide LAR 60 mg.
    id
    OG000
    title
    Up-titrated to Pasireotide LAR 60 mg
param Type
NUMBER
population Description
Extension Full Analysis Set (Extension FAS) included all the patients who received at least one dose of pasireotide LAR in the extension phase.
reporting Status
POSTED
time Frame
Weeks 48, 60 & 72
title
Extension Phase: Percentage of Participants With Mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 & 72 (Up-titrated to Pasireotide LAR 60 mg)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice