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25292
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Study ID: 101468/191 Clinical Study ID: SKF-101468/191 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Ropinirole in Subjects with Restless Legs Syndrome (RLS) Suffering from Periodic Leg Movements of Sleep (PLMS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome
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- 31-08-17 31-08-17 -
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31 augustus 2017
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GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Baseline (Form 2)
GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Baseline (Form 2)
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GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Baseline (Form 2)
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Center Number
Item
Center Number
integer
Patient Number
Item
Patient Number
integer
Patient Initials
Item
Patient Initials
text
Visit Date
Item
Visit Date
date
Pre-Dose (Reading 1) systolic blood pressure after 10 minutes semi-supine
Item
Pre-Dose (Reading 1) systolic blood pressure after 10 minutes semi-supine
integer
Pre-Dose (Reading 1) diastolic blood pressure after 10 minutes semi-supine
Item
Pre-Dose (Reading 1) diastolic blood pressure after 10 minutes semi-supine
integer
Pre-Dose (Reading 1) Pulse after 10 minutes semi-supine
Item
Pre-Dose (Reading 1) Pulse after 10 minutes semi-supine
integer
Pre-Dose (Reading 1) systolic blood pressure after erect for 1 minute
Item
Pre-Dose (Reading 1) systolic blood pressure after erect for 1 minute
integer
Pre-Dose (Reading 1) diastolic blood pressure after erect for 1 minute
Item
Pre-Dose (Reading 1) diastolic blood pressure after erect for 1 minute
integer
Pre-Dose (Reading 1) pulse after erect for 1 minute
Item
Pre-Dose (Reading 1) pulse after erect for 1 minute
integer
Pre-Dose (Reading 2) systolic blood pressure after 10 minutes semi-supine
Item
Pre-Dose (Reading 2) systolic blood pressure after 10 minutes semi-supine
integer
Pre-Dose (Reading 2) diastolic blood pressure after 10 minutes semi-supine
Item
Pre-Dose (Reading 2) diastolic blood pressure after 10 minutes semi-supine
integer
Pre-Dose (Reading 2) pulse after 10 minutes semi-supine
Item
Pre-Dose (Reading 2) pulse after 10 minutes semi-supine
integer
Pre-Dose (Reading 2) systolic blood pressure after erect for 1 minute
Item
Pre-Dose (Reading 2) systolic blood pressure after erect for 1 minute
integer
Pre-Dose (Reading 2) diastolic blood pressure after erect for 1 minute
Item
Pre-Dose (Reading 2) diastolic blood pressure after erect for 1 minute
integer
Pre-Dose (Reading 2) pulse after erect for 1 minute
Item
Pre-Dose (Reading 2) pulse after erect for 1 minute
integer
2 hours Post-Dose (Reading 1) systolic blood pressure after 10 minutes semi-supine
Item
2 hours Post-Dose (Reading 1) systolic blood pressure after 10 minutes semi-supine
integer
2 hours Post-Dose (Reading 1) diastolic blood pressure after 10 minutes semi-supine
Item
2 hours Post-Dose (Reading 1) diastolic blood pressure after 10 minutes semi-supine
integer
2 hours Post-Dose (Reading 1) pulse after 10 minutes semi-supine
Item
2 hours Post-Dose (Reading 1) pulse after 10 minutes semi-supine
integer
2 hours Post-Dose (Reading 1) systolic blood pressure after erect for 1 minute
Item
2 hours Post-Dose (Reading 1) systolic blood pressure after erect for 1 minute
integer
2 hours Post-Dose (Reading 1) diastolic blood pressure after erect for 1 minute
Item
2 hours Post-Dose (Reading 1) diastolic blood pressure after erect for 1 minute
integer
2 hour Post-Dose (Reading 1) pulse after erect for 1 minute
Item
2 hour Post-Dose (Reading 1) pulse after erect for 1 minute
integer
2 hours Post-Dose (Reading 2) systolic blood pressure after 10 minutes semi-supine
Item
2 hours Post-Dose (Reading 2) systolic blood pressure after 10 minutes semi-supine
integer
2 hours Post-Dose (Reading 2) diastolic blood pressure after 10 minutes semi-supine
Item
2 hours Post-Dose (Reading 2) diastolic blood pressure after 10 minutes semi-supine
integer
2 hours Post-Dose (Reading 2) pulse after 10 minutes semi-supine
Item
2 hours Post-Dose (Reading 2) pulse after 10 minutes semi-supine
integer
2 hours Post-Dose (Reading 2) systolic blood pressure after erect for 1 minute
Item
2 hours Post-Dose (Reading 2) systolic blood pressure after erect for 1 minute
integer
2 hours Post-Dose (Reading 2) diastolic blood pressure after erect for 1 minute
Item
2 hours Post-Dose (Reading 2) diastolic blood pressure after erect for 1 minute
integer
2 hour Post-Dose (Reading 2) pulse after erect for 1 minute
Item
2 hour Post-Dose (Reading 2) pulse after erect for 1 minute
integer
PLM
Item
Please record the patient´s PLM per hour of sleep
integer
Polysomnography
Item
Please collect the polysomnography readings from the 2 consecutive nights and send both to the central reader for scoring.
text
1. Subjects with a total score >15 on the RLS Scale at Baseline.
Item
1. Subjects with a total score >15 on the RLS Scale at Baseline.
boolean
2. Subjects must have a PLMI of ³5 PLM per hour of sleep during the second polysomnography recording prior to baseline.
Item
2. Subjects must have a PLMI of ³5 PLM per hour of sleep during the second polysomnography recording prior to baseline.
boolean
secondary RLS
Item
1. Signs of secondary RLS (e.g renal failure (end-stage renal disease), iron deficient anemia (as judged by the investigator) or pregnancy at baseline).
boolean
Augmentation
Item
2. Subjects suffering from augmentation and/or end of dose rebound from former medications at baseline.
boolean
Subjects having clinically significant abnormal laboratory
Item
3. Subjects having clinically significant abnormal laboratory, ECG or physical examination finding not resolved by the time of the baseline examinations.
boolean
Medication affecting RLS or sleep
Item
4. Subjects taking any medication known to induce drowsiness, affect RLS or sleep (the minimum discontinuation period is generally 5 half-lives or 7 consecutive nights medication free, prior to baseline, whicherver is the longer period.
text
Criteria blood pressure
Item
5. Subjects with a diastolic blood pressure >110mmHg or <50mmHg OR systolic blood pressure >180mmHg or <90mmHg at baseline.
boolean
Baseline RLS Rating Scale
Item
Please complete the Baseline RLS rating scale from the RLS Rating Scale Book. Mark the patient´s total score for all 10 items.
integer
Pulse
Item
Pulse (after 5 minutes sitting)
integer
Sitting Blood Pressure (systolic)
Item
Sitting Blood Pressure systolic (after 5 minutes sitting)
integer
Sitting Blood Pressure diastolic
Item
Sitting Blood Pressure diastolic (after 5 minutes sitting)
integer
Concomitant Medication
Item
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
text
Medical Procedures
Item
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
text
Baseline event
Item
Baseline event
text
Onset Date and Time
Item
Onset Date and Time
datetime
End Date and Time
Item
End Date and Time
datetime
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (If patient died, STOP: go to SAE section and follow instructions given there.) (3)
CL Item
Intermittent (-> No. of episodes) (1)
CL Item
Constant (2)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to study procedures performed prior to randomization
text
Code List
Relationship to study procedures performed prior to randomization
CL Item
Related (1)
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
CL Item
Unrelated (4)
Corrective Therapy
Item
Corrective Therapy
boolean
Patient withdrawn due to event
Item
Was patient withdrawn due to this specific event?
boolean
Item
1. Which of the following categories best describes the patient at this time?
text
Code List
1. Which of the following categories best describes the patient at this time?
CL Item
Full time employment (1)
CL Item
Part-time employment -> list approximate hours per week below. (2)
CL Item
Volunteer/Unpaid work -> list approximate hour per week below. (3)
CL Item
Unemployed due to RLS (4)
CL Item
Unemployed due to other (non-RLS) disability (5)
CL Item
Unempoyed for other reason (6)
CL Item
Retired -> Please mention date of retirement below. (7)
CL Item
Homemaker (8)
Part-time employment
Item
If part-time employed, please list approximate hours per week
float
Volunteer/Unpaid work
Item
If volunteer/unpaid work, please list approximate hours per week
integer
Item
If patient is employed (full-time, part-time or an unpaid volunteer) or seeking work, please mark the one option below which best describes the category of the patient´s occupation:
text
Code List
If patient is employed (full-time, part-time or an unpaid volunteer) or seeking work, please mark the one option below which best describes the category of the patient´s occupation:
CL Item
Legislator, senior official or manager (e.g specialist managers, directors and chief executives) (1)
CL Item
Professional (e.g. teaching, legal, science and health professionals) (2)
CL Item
Technician or associate professional (computer associates, nurses/midwifes, ship & aircraft controllers, police inspectors, finance & sales) (3)
CL Item
Clerk (secretaries, cashiers and other office clerks) (4)
CL Item
Service worker or shop and market sales worker (e.g housekeeping and restaurant services, shop salesperson & demonstrators, and models) (5)
CL Item
Skilled agricultural or fishery worker (e.g animal/crop producers, market gardeners, fishery workers, hunters and trappers) (6)
CL Item
Craft and related trade workers (e.g miners, builders, blacksmiths, potters, glass-makers, textile workers) (7)
CL Item
Plant and machine operator or assembler (e.g. metal processing plant operator, food and related products machine operators) (8)
CL Item
Military (9)
Randomization number
Item
Randomization number
integer
Container numbers I
Item
Record the container numbers supplied by RAMOS (1)
text
Container numbers II
Item
Record the container numbers supplied by RAMOS (2)
text
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