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NCT01915303 · OUTCOME

Number of Patients With Shift From Standing Easily to Not Being Able to Stand

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline up to week 267

What was measured

To test proximal muscle strength patients should be placed in a low seated position (for instance on an examination room stool). They should be asked to extend the arms in front of them. From this seated position patients will be asked to stand up. Patients will be evaluated using the following scale: 3. - completely unable to stand 2. - able to stand only by using arms as assistance 1\. - able to stand after several efforts without using arms as assistance 0. - able to stand easily with arms extended

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

GroupSource count
All Patients68

Reported measurements

Core Week 26

Analysis denominator · Participants

GroupSource count
All Patients41
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients1Not reportedNot reportedNot reportedNot reported
Core Week 35

Analysis denominator · Participants

GroupSource count
All Patients32
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      units
      Participants
    title
    Core Week 26
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      units
      Participants
    title
    Core Week 35
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    units
    Participants
description
To test proximal muscle strength patients should be placed in a low seated position (for instance on an examination room stool). They should be asked to extend the arms in front of them. From this seated position patients will be asked to stand up. Patients will be evaluated using the following scale: 3. - completely unable to stand 2. - able to stand only by using arms as assistance 1\. - able to stand after several efforts without using arms as assistance 0. - able to stand easily with arms extended
groups
  1. 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
NUMBER
population Description
Full analysis set
reporting Status
POSTED
time Frame
Baseline up to week 267
title
Number of Patients With Shift From Standing Easily to Not Being Able to Stand
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice