NCT02354508 · OUTCOME

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status

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, overall by baseline diabetic status.

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.

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

Group	Source count
Pasireotide LAR Overall	88

Reported measurements

Diabetic

Analysis denominator · Participants

Group	Source count
Pasireotide LAR Overall	43

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR Overall	14.0	Not reported	5.30	27.93	Not reported

Pre-diabetic

Analysis denominator · Participants

Group	Source count
Pasireotide LAR Overall	36

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR Overall	19.4	Not reported	8.19	36.02	Not reported

Non-diabetic

Analysis denominator · Participants

Group	Source count
Pasireotide LAR Overall	9

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR Overall	0.0	Not reported	0.00	33.63	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
5.30
upper Limit
27.93
value
14.0
denoms
counts
group Id
OG000
value
43
units
Participants
title
Diabetic
categories
measurements
group Id
OG000
lower Limit
8.19
upper Limit
36.02
value
19.4
denoms
counts
group Id
OG000
value
36
units
Participants
title
Pre-diabetic
categories
measurements
group Id
OG000
lower Limit
0.00
upper Limit
33.63
value
0.0
denoms
counts
group Id
OG000
value
9
units
Participants
title
Non-diabetic

denoms

counts
group Id
OG000
value
88
units
Participants

description

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

dispersion Type

95% Confidence Interval

groups

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

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.

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 Overall by Baseline Diabetic Status

type

PRIMARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice