Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
RLS Rating Scale
Item
Patient has a total score > 15 on the RLS Rating Scale at baseline
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
secondary RLS
Item
Signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anemia), or pregnancy at baseline.
boolean
C1536279 (UMLS CUI [1])
Augmentation
Item
Patient suffers from augmentation and/or end of dose rebound at baseline.
boolean
C0473305 (UMLS CUI [1,1])
C0454417 (UMLS CUI [1,2])
abnormal
Item
Patient has clinically significant abnormal laboratory, ECG or physical examination findings not resolved by the time of the baseline examinations.
boolean
C0205161 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,4])
medication
Item
Patient is 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, whichever is the longer period).
boolean
C0013227 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
blood pressure
Item
Patient has a diastolic blood pressure > 110mmHg or < 50mmHg OR systolic blood pressure > 180mmHg or < 90mmHg at baseline.
boolean
C0005823 (UMLS CUI [1])
trial
Item
Patient has participated in any clinical drug or device trial in the 3 months prior to the baseline visit.
boolean
C2347449 (UMLS CUI [1])
hormone replacement therapy
Item
Patient has withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrolment through to the follow-up visit at end of study.
boolean
C0207509 (UMLS CUI [1,1])
C0282402 (UMLS CUI [1,2])
RLS Rating Scale
Item
Mark the patient’s total score for all 10 items
integer
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
RLS Rating Scale
Item
If this score is not more than 15 exclude the patient
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Patient related scales
Item
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
boolean
C0030705 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Sitting Blood Pressure systolic
Item
Sitting Blood Pressure systolic
integer
C0580946 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Sitting Blood Pressure diastolic
Item
Sitting Blood Pressure diastolic
integer
C0580946 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
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.
boolean
C2347852 (UMLS CUI [1])
Medical Procedures
Item
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
boolean
C0199171 (UMLS CUI [1])
no baseline event
Item
Please mark this box if no baseline events occurred prior to randomisation into study.
boolean
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Baseline Event
Item
Baseline Event
text
C0559546 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Onset Date and Time
Item
Onset Date and Time
date
C2981441 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
End Date and Time
Item
End Date and Time
date
C2981425 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item
Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
Event Course
Item
Event Course - Number of episodes
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
C0332189 (UMLS CUI [1,4])
Item
Intensity
integer
C0518690 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item
Relationship to study procedures performed prior to randomisation
integer
C0877248 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
Code List
Relationship to study procedures performed prior to randomisation
CL Item
Possibly related (2)
CL Item
Probably related (3)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Patient withdrawn due to event
Item
Was patient withdrawn due to this specific event?
boolean
C0422727 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Full time employment
Item
Full time employment
boolean
C0682295 (UMLS CUI [1])
Part-time employment
Item
Part-time employment
boolean
C0682294 (UMLS CUI [1])
Part-time employment
Item
Part-time employment: list approximate hours per week:
boolean
C0682294 (UMLS CUI [1,1])
C2584953 (UMLS CUI [1,2])
Volunteer/Unpaid work
Item
Volunteer/Unpaid work
boolean
C2367294 (UMLS CUI [1,1])
C0557361 (UMLS CUI [1,2])
Volunteer/Unpaid work
Item
Volunteer/Unpaid work
boolean
C2367294 (UMLS CUI [1,1])
C0557361 (UMLS CUI [1,2])
C2584953 (UMLS CUI [1,3])
Unemployed due to RLS
Item
Unemployed due to RLS
boolean
C0041674 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Unemployed due to other (NON-RLS) disability
Item
Unemployed due to other (NON-RLS) disability
boolean
C0041674 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,3])
Unemployed for other reason
Item
Unemployed for other reason
boolean
C0041674 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
Retired
Item
Retired
boolean
C0035345 (UMLS CUI [1])
Retired
Item
Date of retirement
date
C0035345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Homemaker
Item
Homemaker
boolean
C0555052 (UMLS CUI [1])
Item
If patient is employed (full-time, part-time or an unpaid volunteer) or seeking work answer question 2 2. Please mark the one box below which best describes the category of the patient's occupation: (International Standard Classification of Occupations, ISCO-88 COM)
integer
C0014003 (UMLS CUI [1])
Code List
If patient is employed (full-time, part-time or an unpaid volunteer) or seeking work answer question 2 2. Please mark the one box below which best describes the category of the patient's occupation: (International Standard Classification of Occupations, ISCO-88 COM)
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/midwives, ship & aircraft controllers, police inspectors, finance & sales) (3)
CL Item
Clerk (e.g. 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 trades worker (e.g. miners, builders, blacksmiths, potters, glass-makers, textile workers) (7)
CL Item
Plant and machine operator or assembler (e.g. metal processing plant operators, food and related products machine operators) (8)
CLINICAL GLOBAL IMPRESSION
Item
CLINICAL GLOBAL IMPRESSION
boolean
C3639708 (UMLS CUI [1])
Randomisation number
Item
Randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Container number
Item
Container number
text
C0180098 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])