Ropinirole Case Report Form GSK RRL100013

Beskrivning

A CTIGRAPHY INSTRUCTIONS 1. Refer to the Study Reference Manual for instructions on collecting and downloading the data from the actigraphy device(s). DIARY INSTRUCTIONS 1. Retrieve and review the Dosing and Actigraphy Diary for the Week 10 to Week 12 Visit PGx INSTRUCTIONS 1. If the subject consented to participate in the PGx-Pharmacogenetic research and has taken at least one dose of study medication, collect the blood sample during this visit. CONCOMITANT MEDICATION 1. Remind the subject he/she is not allowed to take any medication for RLS or that affects sleep until after completion of the Follow-up Visit. SCHEDULING NEXT VISIT 1. Arrange for the subject to return in 7 days(+/- 3 days) for the Follow-Up visit.

Datatyp

text

Alias

UMLS CUI [1]

C1442085

Beskrivning

DIARY INSTRUCTIONS 1. Retrieve and review the diary dispensed to the subject at the last study visit PGx INSTRUCTIONS 1. If the subject consented to participate in the PGx-Pharmacogenetic research and has taken at least one dose of study medication, collect the blood sample during this visit. CONCOMITANT MEDICATIONS 1. Remind the subject he/she is not allowed to take any medication for RLS or that affects sleep until after completion of the Follow-up Visit. SCHEDULING NEXT VISIT 1. Arrange for the subject to return in 7 days(+/- 3 days) for the Follow-up Visit.

Datatyp

text

Alias

UMLS CUI [1]

C2349954

Beskrivning

CONCOMITANT MEDICATIONS

Datatyp

text

Alias

UMLS CUI [1]

C2347852

Beskrivning

Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Event section.

Datatyp

text

Alias

UMLS CUI [1]

C0877248

Beskrivning

Semi-supine measurements must be taken first, followed straight away by the standing measurements. Blood pressure and pulse rate measurements must be recorded in both the semi-supine and standing position. Semi-supine will be defined as the subject lying flat with two pillows under his/her head. Semi-supine pulse and blood measurements will be made after the subject has been resting semi-supine for a period of at least 10 minutes. • A standing blood pressure and pulse measurement will be taken after the subject has been standing for a period of one minute. • Any clinically significant worsening will be recorded on the Adverse Event or SAE page of the CRF. Blood pressure measurements should not be conducted within 15 minutes of a blood sample. If the blood pressure measurement is conducted after the blood sample, you should ensure that the subject has recovered from the venepuncture before the blood pressure measurement. The blood pressure cuff must be placed on the same arm throughout the study. The same study nurse/medical professional should conduct all the blood pressure/pulse measurements for each clinic visit Ideally, the same study nurse/medical professional should conduct all the blood pressure/pulse measurements for each patient throughout the study.

Datatyp

text

Alias

UMLS CUI [1,1]

C0518766

UMLS CUI [1,2]

C1442085

Beskrivning

If subject is female and of childbearing potential a urine pregnancy test must be performed.

Datatyp

text

Alias

UMLS CUI [1]

C0430056