Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02354508 · OUTCOME

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Wek 36

What was measured

Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36.

Analysis population: Per-Protocol Set (PPS): consisted of a subset of the patients in the FAS who were compliant with requirements of the clinical study protocol. The protocol deviations criteria were defined prior to database lock. Per-protocol analysis was performed during the core phase, but not during the extension phase.

Groups in this outcome

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
Pasireotide LAR Overall102

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall15.7Not reported9.2424.22Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.24
        upper Limit
        24.22
        value
        15.7
denoms
  1. counts
    1. group Id
      OG000
      value
      102
    units
    Participants
description
Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36.
dispersion Type
95% Confidence Interval
groups
  1. description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
    id
    OG000
    title
    Pasireotide LAR Overall
param Type
NUMBER
population Description
Per-Protocol Set (PPS): consisted of a subset of the patients in the FAS who were compliant with requirements of the clinical study protocol. The protocol deviations criteria were defined prior to database lock. Per-protocol analysis was performed during the core phase, but not during the extension phase.
reporting Status
POSTED
time Frame
Wek 36
title
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice