GSK study: Ropinirole in RLS patients 101468/243 - Week 1

Beschrijving

Please complete the study medication record in the Study Medication and Compliance Section at the back of this module.

Datatype

text

Alias

UMLS CUI [1,1]

C2734539

UMLS CUI [1,2]

C0008972

Beschrijving

Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book

Datatype

text

Alias

UMLS CUI [1,1]

C0681889

UMLS CUI [1,2]

C0035258

Beschrijving

after 5min sitting

Datatype

integer

Maateenheden

• betas/min

Alias

UMLS CUI [1]

C0232117

Beschrijving

after 5 minutes sitting

Datatype

integer

Maateenheden

• mmHg

Alias

UMLS CUI [1,1]

C0871470

UMLS CUI [1,2]

C0277814

Beschrijving

Sitting diastolic blood pressure

Datatype

integer

Maateenheden

• mmHg

Alias

UMLS CUI [1,1]

C0428883

UMLS CUI [1,2]

C0277814

Beschrijving

Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this module

Datatype

text

Alias

UMLS CUI [1]

C0199171

Beschrijving

Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this module

Datatype

text

Alias

UMLS CUI [1]

C2347852

Beschrijving

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 section at the back of this module

Datatype

text

Alias

UMLS CUI [1]

C0559546

Beschrijving

Guided by the CGI Efficacy Index (below) determine dose level to be dispensed and dispense Week 2 study medication. Complete the Study Medication and Compliance Section at the back of this module. 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 in 7 days (plus or minus 3 days) for the Week 2 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.

Datatype

text

Alias

UMLS CUI [1,1]

C0302828

UMLS CUI [1,2]

C0035173

Beschrijving

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

Datatype

text

Alias

UMLS CUI [1]

C3639708

Beschrijving

If the patient requires a dose reduction between this and the next visit please complete Dose Reductions Due To Adverse Experiences pages at the back of this module. Dosage reduction may occur between scheduled clinic visits, if necessary. The subject will be instructed to contact the site to arrange a visit should a dose decrease become necessary outside of the regularly specified protocol visit.

Datatype

text

Alias

UMLS CUI [1]

C1707814