NCT02354508 · OUTCOME

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants 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: Week 36

What was measured

Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, for participants who had been up-titrated with pasireotide LAR 60 mg.

Analysis population: Full Analysis Set (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. For these patients the Pasireotide LAR dose was uptitrated to 60 mg before Week 36.

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

Group	Source count
Up-titrated to Pasireotide LAR 60 mg	90

Reported measurements

Source class 1

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Up-titrated to Pasireotide LAR 60 mg	6.7	Not reported	2.49	13.95	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
2.49
upper Limit
13.95
value
6.7

denoms

counts
group Id
OG000
value
90
units
Participants

description

Percentage of participants who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, for participants who had been up-titrated with pasireotide LAR 60 mg.

dispersion Type

95% Confidence Interval

groups

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

Full Analysis Set (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. For these patients the Pasireotide LAR dose was uptitrated to 60 mg before Week 36.

reporting Status

POSTED

time Frame

Week 36

title

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg

type

PRIMARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice