GSK study: Ropinirole in RLS patients 101468/243 - Evening Visits for Orthostatic Vital Signs, Unscheduled Week 5

Descripción

Please complete the study medication record in the Study Medication and Compliance Section.

Tipo de datos

text

Alias

UMLS CUI [1,1]

C2734539

UMLS CUI [1,2]

C0008972

Descripción

Please record any medical procedures performed since the last visit in the Medical Procedures section.

Tipo de datos

text

Alias

UMLS CUI [1]

C0199171

Descripción

lease record any changes in concomitant medication since the last visit in the Concomitant Medication section.

Tipo de datos

text

Alias

UMLS CUI [1]

C2347852

Descripción

Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section.

Tipo de datos

text

Alias

UMLS CUI [1]

C0559546

Descripción

Guided by the CGI Efficacy Index (below) determine dose level of study medication to be dispensed. Complete the Study Medication and Compliance Section. If the patient’s dose has been increased at this clinic visit: a) Instruct the patient to return to the clinic this evening or remain to perform orthostatic vital signs*: - 2 sets of pre-dose orthostatic blood pressure and pulse - Patient takes evening dose in the clinic - One set of 2 hour post-dose orthostatic blood pressure and pulse Instruct the patient to take the appropriate number of tablet(s), at the same time, no earlier than 3 hours prior to and no later than one hour prior to bedtime (except on the first night of each new dose increase). Patient must return the bottle(s) with any unused medication at the next visit. Arrange for the patient to return for next scheduled clinic visit. * Where possible this visit should be performed in the evening with dosing approximately 8:00 P.M. However, for scheduling convenience, this visit (including dosing) may occur during the afternoon hours (as late in the day as possible) to accomodate the collection of orthostatic blood pressure/pulse assessments during the normal clinic hours.

Tipo de datos

text

Alias

UMLS CUI [1,1]

C0302828

UMLS CUI [1,2]

C0035173

Descripción

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Tipo de datos

text

Alias

UMLS CUI [1]

C3639708

Descripción

If the patient requires a dose change between this and the next visit please complete Dose Changes pages.

Tipo de datos

text

Alias

UMLS CUI [1]

C1707811

Descripción

ONLY TAKE ORTHOSTATIC VITAL SIGNS IF A DOSE INCREASE OCCURS Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 minutes and erect measurements will be taken after the patient has been standing for a period of 1 minute. • The blood pressure cuff must be placed on the same arm throughout the study. • Ideally, the same study nurse/medical professional should conduct all the blood pressure/pulse measurements for each clinic visit and each patient throughout the study. • Pre-dose orthostatic measurements will commence approximately 30 minutes prior to dosing and each set will be separated by 10 minutes rest in the semi-supine position. • Two sets of stable, consecutive pre-dose semi-supine and erect blood pressure measurements as well as two sets of pulse rate measurements will be taken. Stable is defined as three measurements within +15mmHg of the lowest measurement. • One set of orthostatic blood pressure and pulse measurements will be taken 2 hours post dose.

Tipo de datos

text

Alias

UMLS CUI [1,1]

C0518766

UMLS CUI [1,2]

C1442085

Descripción

Pre-dose reading

Tipo de datos

integer

Alias

UMLS CUI [1,1]

C1522609

UMLS CUI [1,2]

C0439565

Descripción

Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo de datos

time

Alias

UMLS CUI [1,1]

C0518766

UMLS CUI [1,2]

C0040223

Descripción

Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo de datos

integer

Unidades de medida

• mmHg

Alias

UMLS CUI [1]

C0871470

Descripción

Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo de datos

integer

Unidades de medida

• mmHg

Alias

UMLS CUI [1]

C0428883

Descripción

Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo de datos

integer

Unidades de medida

• beats/min

Alias

UMLS CUI [1]

C0232117

Descripción

Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

Tipo de datos

time

Alias

UMLS CUI [1,1]

C0518766

UMLS CUI [1,2]

C0040223

Descripción

Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

Tipo de datos

integer

Unidades de medida

• mmHg

Alias

UMLS CUI [1]

C0871470

Descripción

Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

Tipo de datos

integer

Unidades de medida

• mmHg

Alias

UMLS CUI [1]

C0428883

Descripción

Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

Tipo de datos

integer

Unidades de medida

• beats/min

Alias

UMLS CUI [1]

C0232117

Descripción

Time of dose

Tipo de datos

time

Unidades de medida

• Hr : Min

Alias

UMLS CUI [1,1]

C0013227

UMLS CUI [1,2]

C0040223

Descripción

Dose level

Tipo de datos

text

Alias

UMLS CUI [1]

C0178602

Descripción

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Tipo de datos

time

Alias

UMLS CUI [1,1]

C0518766

UMLS CUI [1,2]

C0040223

Descripción

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Tipo de datos

integer

Unidades de medida

• mmHg

Alias

UMLS CUI [1]

C0871470

Descripción

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Tipo de datos

integer

Unidades de medida

• mmHg

Alias

UMLS CUI [1]

C0871470

Descripción

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Tipo de datos

integer

Unidades de medida

• beats/min

Alias

UMLS CUI [1]

C0232117

Descripción

Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

Tipo de datos

time

Descripción

Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose. in mmHg; systolic/diastolic

Tipo de datos

integer

Unidades de medida

• mmHg

Alias

UMLS CUI [1]

C0871470

Descripción

Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

Tipo de datos

integer

Unidades de medida

• mmHg

Alias

UMLS CUI [1]

C0428883

Descripción

Pre-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

Tipo de datos

integer

Unidades de medida

• beats/min

Alias

UMLS CUI [1]

C0232117