REQUIP RLS Post Marketing Surveillance

Study Overview
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Brief Summary
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post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS

Detailed Description
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This study is a post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS(restless leg syndrome) and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to identify prognostic factors that have an effect on the AEs and to assess effectiveness of ropinirole in real clinical practices after marketing. The subjects are patients prescribed for ropinirole by the investigators at the sites based on prescription information in normal clinical practices.

Official Title
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An Open-label, Multi-centre, Observational, Post-marketing Surveillance to Monitor the Safety of REQUIP(Ropinirole) Administered in Korean Restless Leg Syndrome Patients According to the Prescribing Information

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Drug: Ropinirole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects diagnosed with RLS by the investigator Subjects who the investigator believes that they can and will comply with the requirements of the protocol To be contactable over the phone To follow the administration regimen. A male or female aged 18 years and more at the time of the first prescription. Subjects with no experience of RLS treatment using ropinirole Exclusion Criteria: Considering the nature of this non-interventional PMS study, there is no strict exclusion criteria set up. GSK Korea encourage the doctors participating this study to enrol the subjects prescribed with Ropinirole following the locally approved Prescribing Information (Appendix ) The following criteria should be checked at the time of study entry. Subjects with hypersensitivity to ropinirole and any excipients Female who is during the period of the pregnancy or who are lactating
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects eligible for REQUIP prescription<br>Male and female subjects who were considered appropriate to be prescribed REQUIP according to the prescribing information will be included in this study. | Drug: Ropinirole<br>* Basically there is no treatment allocation. Subjects who would be administered of ropinirole at their physician's direction will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Any Adverse Event | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Any Serious Adverse Event | A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening , requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record. | one month | 
| Number of Participants With the Indicated Unexpected Adverse Events | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings. | one month |