Restless Legs Syndrome
Conditions
Brief summary
post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS
Detailed description
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.
Interventions
DRUGRopinirole
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.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Event | one month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Serious Adverse Event | one month | 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. |
| Number of Participants With the Indicated Unexpected Adverse Events | one month | 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. |
Participant flow
Recruitment details
The objective of this post-marketing surveillance (PMS) study was to monitor the safety and efficacy of Requip under the real clinical setting after launch.
Participants by arm
| Arm | Count |
|---|---|
| Requip 0.25 mg, 1 mg, 2 mg Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily | 747 |
| Total | 747 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 8 |
Baseline characteristics
| Characteristic | Requip 0.25 mg, 1 mg, 2 mg |
|---|---|
| Age, Continuous | 60.9 Years STANDARD_DEVIATION 13.4 |
| Race/Ethnicity, Customized Korean | 747 participants |
| Race/Ethnicity, Customized Not Korean | 0 participants |
| Sex: Female, Male Female | 440 Participants |
| Sex: Female, Male Male | 307 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 44 / 747 |
| serious Total, serious adverse events | 3 / 747 |
Outcome results
Primary
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.
Time frame: one month
Population: Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Requip 0.25 mg, 1 mg, 2 mg | Number of Participants With Any Adverse Event | 44 participants |
95% CI: [4.3, 7.8]
Secondary
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.
Time frame: one month
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Requip 0.25 mg, 1 mg, 2 mg | Number of Participants With Any Serious Adverse Event | 3 participants |
Secondary
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.
Time frame: one month
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Requip 0.25 mg, 1 mg, 2 mg | Number of Participants With the Indicated Unexpected Adverse Events | Eye Pain | 1 participants |
| Requip 0.25 mg, 1 mg, 2 mg | Number of Participants With the Indicated Unexpected Adverse Events | Saliva Increased | 1 participants |
| Requip 0.25 mg, 1 mg, 2 mg | Number of Participants With the Indicated Unexpected Adverse Events | Weight Decrease | 2 participants |
| Requip 0.25 mg, 1 mg, 2 mg | Number of Participants With the Indicated Unexpected Adverse Events | Thirsty | 1 participants |
| Requip 0.25 mg, 1 mg, 2 mg | Number of Participants With the Indicated Unexpected Adverse Events | Melena | 1 participants |
| Requip 0.25 mg, 1 mg, 2 mg | Number of Participants With the Indicated Unexpected Adverse Events | Amnesia | 1 participants |
| Requip 0.25 mg, 1 mg, 2 mg | Number of Participants With the Indicated Unexpected Adverse Events | Appendicitis | 1 participants |