NCT01915303 · OUTCOME

Sitting Diastolic Blood Pressure at Week 35

Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's Disease · Source last updated 2020-09-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: mmHg
Interval / dispersion: Standard Deviation
Time frame: Baseline and week 35

What was measured

The mean arterial blood pressure determinations were obtained in the sitting position. Three measurements were taken with 5 minute intervals and the mean was used for study specific procedures

Analysis population: Full analysis set

Groups in this outcome

All Patients

Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension

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
All Patients	68

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
All Patients	68

Values in mmHg · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	81.8	9.12	Not reported	Not reported	Not reported

Week 35 n=41

Analysis denominator · Participants

Group	Source count
All Patients	41

Values in mmHg · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	77.2	12.42	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
9.12
value
81.8
denoms
counts
group Id
OG000
value
68
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
12.42
value
77.2
denoms
counts
group Id
OG000
value
41
units
Participants
title
Week 35 n=41

denoms

counts
group Id
OG000
value
68
units
Participants

description

The mean arterial blood pressure determinations were obtained in the sitting position. Three measurements were taken with 5 minute intervals and the mean was used for study specific procedures

dispersion Type

Standard Deviation

groups

description
Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension
id
OG000
title
All Patients

param Type

MEAN

population Description

Full analysis set

reporting Status

POSTED

time Frame

Baseline and week 35

title

Sitting Diastolic Blood Pressure at Week 35

type

SECONDARY

unit Of Measure

mmHg

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

Preserved source evidence · Not medical advice