ID

27188

Beschreibung

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) 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: Parkinson Disease Module: Screening

Stichworte

Versionen (1)
  1. 03.11.17 03.11.17 -
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GlaxoSmithKline

Hochgeladen am

3. November 2017

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GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188

Englisch

Screening

1 Formulare  
  1. StudyEvent: ODM
    1. Screening
Screening
Beschreibung

Screening

Alias
UMLS CUI-1
C1710477
UMLS CUI-2
C1516637
UMLS CUI-3
C0013893
Centre Number
Beschreibung

Centre Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Number
Beschreibung

Patient Number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
How old was the patient at the onset of RLS?
Beschreibung

age of onset restless legs syndrome

Datentyp

integer

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0206132
Did the patient start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
Beschreibung

medication caused RLS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0085978
If ’Yes’ please specify medication(s)
Beschreibung

medication caused RLS

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0035258
If female, did RLS symptoms develop during pregnancy?
Beschreibung

RLS symptoms develop during pregnancy

Datentyp

integer

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C1457887
Has the patient ever had PLMS (Periodic Limb Movements during Sleep)?
Beschreibung

PLMS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0596840
UMLS CUI [1,2]
C0037313
UMLS CUI [2]
C0035258
If 'Yes': How old was the patient at the onset of PLMS?
Beschreibung

age of onset of PLMS

Datentyp

integer

Alias
UMLS CUI [1,1]
C0206132
UMLS CUI [1,2]
C0596840
UMLS CUI [1,3]
C0037313
UMLS CUI [2]
C0035258
Does the patient drink alcohol?
Beschreibung

alcohol consumption

Datentyp

boolean

Alias
UMLS CUI [1]
C0001948
If 'Yes": Units/week
Beschreibung

One unit is equivalent to: US - 1.5oz hard liquor, 1 beer, 4oz wine UK - 1 measure spirits, 1/2 pt beer, 1 small glass of wine

Datentyp

integer

Maßeinheiten
  • Units/week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
Units/week
Does the patient drink caffeine (coffee, tea, caffeinated drinks)?
Beschreibung

consumption of caffeine

Datentyp

boolean

Alias
UMLS CUI [1]
C0948365
If 'Yes': Cups/day
Beschreibung

consumption of caffeine

Datentyp

integer

Maßeinheiten
  • Cups/day
Alias
UMLS CUI [1]
C0948365
Cups/day
Does the patient have any sleep disorder as defined by DSM IV?
Beschreibung

sleep disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0851578
UMLS CUI [1,2]
C0220952
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
Beschreibung

first degree relative diagnosed with RLS

Datentyp

integer

Alias
UMLS CUI [1,1]
C1517194
UMLS CUI [1,2]
C0035258
Are the patient’s current symptoms mainly present ...
Beschreibung

time symptoms present

Datentyp

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C0040223
RLS Diagnostic Criteria
Beschreibung

RLS Diagnostic Criteria

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C0679228
1)...a desire to move the limbs usually associated with parethesias or dysesthesias
Beschreibung

The International RLS Study Group Criteria* defines RLS patients as having: Answer to all four diagnostic criteria must be ’Yes’ for the patient to be diagnosed with RLS

Datentyp

boolean

Alias
UMLS CUI [1]
C0596840
UMLS CUI [2]
C0030554
UMLS CUI [3]
C0392699
UMLS CUI [4]
C0035258
2)...motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort)
Beschreibung

The International RLS Study Group Criteria* defines RLS patients as having:

Datentyp

boolean

Alias
UMLS CUI [1]
C0700075
3) ...symptoms worse or exclusively present at rest with at least partial or temporal relief by activity
Beschreibung

The International RLS Study Group Criteria* defines RLS patients as having:

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0026606
UMLS CUI [1,3]
C0564405
4) ...symptoms worse in the evening or night
Beschreibung

The International RLS Study Group Criteria* defines RLS patients as having:

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3176727
UMLS CUI [1,2]
C0035258
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
Race, if other please specify
Beschreibung

Race

Datentyp

text

Alias
UMLS CUI [1]
C0034510
Vital signs
Beschreibung

Vital signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0031809
Height
Beschreibung

(without shoes)

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

(without shoes)

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Sitting blood pressure systolic
Beschreibung

Sitting blood pressure systolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting blood pressure diastolic
Beschreibung

Sitting blood pressure diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Sitting heart rate
Beschreibung

Sitting heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0277814
beats/min
Electrocardiogram
Beschreibung

Electrocardiogram

Alias
UMLS CUI-1
C0013798
UMLS CUI-2
C0430456
Date of ECG
Beschreibung

Date of ECG

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Were any clinically significant abnormalities detected?
Beschreibung

ECG abnormalities

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0430456
Laboratory Evaluation
Beschreibung

Laboratory Evaluation

Alias
UMLS CUI-1
C0022885
Date of blood sample
Beschreibung

Date of blood sample

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Were any clinically significant abnormalities detected?
Beschreibung

laboratory abnormalities

Datentyp

boolean

Alias
UMLS CUI [1]
C1853129
Urine Dipstick
Beschreibung

Urine Dipstick

Alias
UMLS CUI-1
C0430370
What was the result of the urine dipstick performed at this visit?
Beschreibung

result of the urine dipstick

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Pregnancy dipstick
Beschreibung

Pregnancy dipstick

Alias
UMLS CUI-1
C0430056
UMLS CUI-2
C0430370
Is the patient a female of child-bearing potential?
Beschreibung

child-bearing potential

Datentyp

boolean

Alias
UMLS CUI [1]
C1960468
Pregnancy dipstick test result
Beschreibung

If ’Yes’, please perform a pregnancy dipstick test and record result below.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0427777
UMLS CUI [1,2]
C0430370
Significant medical/surgical history and physical examination
Beschreibung

Significant medical/surgical history and physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
UMLS CUI-3
C0012634
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition?
Beschreibung

medical or surgical condition

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0009488
Diagnosis
Beschreibung

If the patient is suffering from or has ever suffered from any significant medical or surgical condition please list below one diagnosis per line. (Please print clearly)

Datentyp

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0009488
Year of first diagnosis
Beschreibung

Year of first diagnosis

Datentyp

partialDate

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0439234
Medical condition ongoing
Beschreibung

Medical condition ongoing

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
Prior and concomitant medication
Beschreibung

Prior and concomitant medication

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0013227
UMLS CUI-3
C2826257
Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS) in the 3 months prior to study entry?
Beschreibung

If ‘Yes’, please record details below (Please print clearly)

Datentyp

boolean

Alias
UMLS CUI [1]
C0013227
Drug Name (Trade Name Preferred)
Beschreibung

Drug Name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
mg
Medical Illness/Diagnosis
Beschreibung

Medical Illness/Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C3146298
Start Date of medication (be as precise as possible)
Beschreibung

Start Date of medication

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date of medication
Beschreibung

(or if Continuing mark box in upcoming question)

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication continuing?
Beschreibung

Medication continuing?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
RLS pharmacotherapy history
Beschreibung

RLS pharmacotherapy history

Alias
UMLS CUI-1
C0013216
UMLS CUI-2
C0035258
Has the patient taken any pharmacotherapy medication for treatment of RLS?
Beschreibung

If ‘Yes’, please record details below (Please print clearly)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0035258
Drug Name (Trade Name Preferred)
Beschreibung

Drug Name

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0013216
Start Date pharmacotherapy (be as precise as possible)
Beschreibung

Start Date pharmacotherapy

Datentyp

date

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0808070
End Date pharmacotherapy
Beschreibung

(or if Continuing mark box in upcoming question)

Datentyp

date

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0806020
Medication continuing?
Beschreibung

Medication continuing?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0549178
Did the patient respond to the treatment?
Beschreibung

Did the patient respond to the treatment?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C0035258
Did the patient tolerate the treatment?
Beschreibung

Did the patient tolerate the treatment?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013220
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C0035258
Screening Inclusion/Exclusion Criteria
Beschreibung

Screening Inclusion/Exclusion Criteria

Alias
UMLS CUI-1
C1710477
UMLS CUI-2
C0013893
Patient is diagnosed with RLS using IRLSSG diagnostic criteria with a history of a minimum of 15 nights of RLS symptoms during the previous month. In the case of a patient currently receiving medication for the treatment of RLS, the Investigator should use their clinical judgement to assess whether that patient would have suffered from a minimum of 15 nights with RLS symptoms if they had not been taking any medication.
Beschreibung

Please complete the following inclusion criteria. If any of the above questions have been answered ’No’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

Datentyp

boolean

Alias
UMLS CUI [1]
C0035258
UMLS CUI [2]
C1512693
Patient is ≥ 18 years old and < 80 years of age.
Beschreibung

Please complete the following inclusion criteria. If any of the above questions have been answered ’No’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1512693
Patient has given written informed consent prior to any specific study procedures.
Beschreibung

Please complete the following inclusion criteria. If any of the above questions have been answered ’No’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1512693
Patient is suffering from RLS symptoms which require treatment during the daytime (daytime defined as 10.00 until 18.00).
Beschreibung

Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0332169
UMLS CUI [2]
C0680251
Patient suffers from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
Beschreibung

Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

Datentyp

boolean

Alias
UMLS CUI [1]
C0236991
UMLS CUI [2]
C0680251
Patient is suffering from a movement disorder (e.g. Parkinson’s Disease, dyskinesias or dystonias).
Beschreibung

Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

Datentyp

boolean

Alias
UMLS CUI [1]
C0026650
UMLS CUI [2]
C0680251
Patient has medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, etc.).
Beschreibung

Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1280519
UMLS CUI [2]
C0680251
Patient has exhibited intolerance to ropinirole or any other dopamine agonist.
Beschreibung

Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0178601
UMLS CUI [2]
C0680251
Patient meets DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 6 months prior to Screening
Beschreibung

Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0680251
Patient is a woman, of childbearing potential who is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant). Please refer to document: CD-5.5, Informed Consent (Phase I-IV), section entitled ’Recommendations For Use of Women Of Childbearing Potential in Clinical Research Studies for SmithKline Beecham’
Beschreibung

Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

Datentyp

boolean

Alias
UMLS CUI [1]
C0420837
UMLS CUI [2]
C0680251
Patient is a woman who has a positive pregnancy test or is lactating.
Beschreibung

Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
UMLS CUI [2]
C0680251
Patient has clinically significant or unstable medical conditions which in the opinion of the investigator would render the patient unsuitable for the study (e.g. symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, etc.).
Beschreibung

Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0009488
UMLS CUI [2]
C0680251
Patient who, in the opinion of the Investigator, would be non-compliant with the visit schedule or other study procedures.
Beschreibung

Please complete the following exclusion criteria. If any of the above questions have been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page at the back of this book.

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0680251
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Ähnliche Modelle

Screening

1 Formulare
  1. StudyEvent: ODM
    1. Screening
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Screening
C1710477 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
C0013893 (UMLS CUI-3)
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])
age of onset restless legs syndrome
Item
How old was the patient at the onset of RLS?
integer
C0035258 (UMLS CUI [1,1])
C0206132 (UMLS CUI [1,2])
medication caused RLS
Item
Did the patient start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
boolean
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
medication caused RLS
Item
If ’Yes’ please specify medication(s)
text
C0013227 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item
If female, did RLS symptoms develop during pregnancy?
integer
C0035258 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
RLS symptoms develop during pregnancy
Code List
If female, did RLS symptoms develop during pregnancy?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not applicable (3)
PLMS
Item
Has the patient ever had PLMS (Periodic Limb Movements during Sleep)?
boolean
C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0035258 (UMLS CUI [2])
age of onset of PLMS
Item
If 'Yes': How old was the patient at the onset of PLMS?
integer
C0206132 (UMLS CUI [1,1])
C0596840 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2])
alcohol consumption
Item
Does the patient drink alcohol?
boolean
C0001948 (UMLS CUI [1])
alcohol consumptions
Item
If 'Yes": Units/week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
consumption of caffeine
Item
Does the patient drink caffeine (coffee, tea, caffeinated drinks)?
boolean
C0948365 (UMLS CUI [1])
consumption of caffeine
Item
If 'Yes': Cups/day
integer
C0948365 (UMLS CUI [1])
sleep disorder
Item
Does the patient have any sleep disorder as defined by DSM IV?
boolean
C0851578 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
Item
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
integer
C1517194 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
first degree relative diagnosed with RLS
Code List
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Are the patient’s current symptoms mainly present ...
integer
C1457887 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
time symptoms present
Code List
Are the patient’s current symptoms mainly present ...
CL Item
At nightime only (1)
CL Item
In evening and nightime (2)
CL Item
Daytime, evening and nightime (3)
Item Group
RLS Diagnostic Criteria
C0035258 (UMLS CUI-1)
C0679228 (UMLS CUI-2)
desire to move the limbs usually associated with parethesias or dysesthesias
Item
1)...a desire to move the limbs usually associated with parethesias or dysesthesias
boolean
C0596840 (UMLS CUI [1])
C0030554 (UMLS CUI [2])
C0392699 (UMLS CUI [3])
C0035258 (UMLS CUI [4])
motor restlessness
Item
2)...motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort)
boolean
C0700075 (UMLS CUI [1])
symptoms worse at rest with at least partial or temporal relief by activity
Item
3) ...symptoms worse or exclusively present at rest with at least partial or temporal relief by activity
boolean
C0035258 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
C0564405 (UMLS CUI [1,3])
symptoms worse in the evening or night
Item
4) ...symptoms worse in the evening or night
boolean
C3176727 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (1)
CL Item
Black (2)
CL Item
Oriental (3)
CL Item
Other (4)
Race
Item
Race, if other please specify
text
C0034510 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Sitting blood pressure systolic
Item
Sitting blood pressure systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting blood pressure diastolic
Item
Sitting blood pressure diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting heart rate
Item
Sitting heart rate
integer
C0018810 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Electrocardiogram
C0013798 (UMLS CUI-1)
C0430456 (UMLS CUI-2)
Date of ECG
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
ECG abnormalities
Item
Were any clinically significant abnormalities detected?
boolean
C0522055 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item Group
Laboratory Evaluation
C0022885 (UMLS CUI-1)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
laboratory abnormalities
Item
Were any clinically significant abnormalities detected?
boolean
C1853129 (UMLS CUI [1])
Item Group
Urine Dipstick
C0430370 (UMLS CUI-1)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
result of the urine dipstick
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Pregnancy dipstick
C0430056 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
child-bearing potential
Item
Is the patient a female of child-bearing potential?
boolean
C1960468 (UMLS CUI [1])
Item
Pregnancy dipstick test result
integer
C0427777 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
result of the urine dipstick
Code List
Pregnancy dipstick test result
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Significant medical/surgical history and physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
medical or surgical condition
Item
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition?
boolean
C0012634 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Year of first diagnosis
Item
Year of first diagnosis
partialDate
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Item
Medical condition ongoing
integer
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Medical condition
Code List
Medical condition ongoing
CL Item
Past (1)
CL Item
Ongoing (2)
CL Item
Past + Ongoing (3)
Item Group
Prior and concomitant medication
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C2826257 (UMLS CUI-3)
medication
Item
Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS) in the 3 months prior to study entry?
boolean
C0013227 (UMLS CUI [1])
Drug Name
Item
Drug Name (Trade Name Preferred)
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical Illness/Diagnosis
Item
Medical Illness/Diagnosis
text
C0011900 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Start Date of medication
Item
Start Date of medication (be as precise as possible)
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of medication
Item
End Date of medication
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication continuing?
Item
Medication continuing?
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
RLS pharmacotherapy history
C0013216 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
pharmacotherapy medication for treatment of RLS
Item
Has the patient taken any pharmacotherapy medication for treatment of RLS?
boolean
C0013216 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Drug Name
Item
Drug Name (Trade Name Preferred)
text
C2360065 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
Start Date pharmacotherapy
Item
Start Date pharmacotherapy (be as precise as possible)
date
C0013216 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date pharmacotherapy
Item
End Date pharmacotherapy
date
C0013216 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication continuing?
Item
Medication continuing?
boolean
C0013216 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
Did the patient respond to the treatment?
integer
C0521982 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
first degree relative diagnosed with RLS
Code List
Did the patient respond to the treatment?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Did the patient tolerate the treatment?
integer
C0013220 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
first degree relative diagnosed with RLS
Code List
Did the patient tolerate the treatment?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item Group
Screening Inclusion/Exclusion Criteria
C1710477 (UMLS CUI-1)
C0013893 (UMLS CUI-2)
diagnosed with RLS
Item
Patient is diagnosed with RLS using IRLSSG diagnostic criteria with a history of a minimum of 15 nights of RLS symptoms during the previous month. In the case of a patient currently receiving medication for the treatment of RLS, the Investigator should use their clinical judgement to assess whether that patient would have suffered from a minimum of 15 nights with RLS symptoms if they had not been taking any medication.
boolean
C0035258 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
age
Item
Patient is ≥ 18 years old and < 80 years of age.
boolean
C0001779 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
informed consent
Item
Patient has given written informed consent prior to any specific study procedures.
boolean
C0021430 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
RLS symptoms daytime
Item
Patient is suffering from RLS symptoms which require treatment during the daytime (daytime defined as 10.00 until 18.00).
boolean
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332169 (UMLS CUI [1,3])
C0680251 (UMLS CUI [2])
primary sleep disorder
Item
Patient suffers from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
boolean
C0236991 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
movement disorder
Item
Patient is suffering from a movement disorder (e.g. Parkinson’s Disease, dyskinesias or dystonias).
boolean
C0026650 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
medical conditions with symptoms which could affect assessments of efficacy
Item
Patient has medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, etc.).
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1280519 (UMLS CUI [1,3])
C0680251 (UMLS CUI [2])
intolerance to dopamine agonist
Item
Patient has exhibited intolerance to ropinirole or any other dopamine agonist.
boolean
C0020517 (UMLS CUI [1,1])
C0178601 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
substance abuse
Item
Patient meets DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 6 months prior to Screening
boolean
C0038586 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
contraception
Item
Patient is a woman, of childbearing potential who is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant). Please refer to document: CD-5.5, Informed Consent (Phase I-IV), section entitled ’Recommendations For Use of Women Of Childbearing Potential in Clinical Research Studies for SmithKline Beecham’
boolean
C0420837 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
positive pregnancy test or is lactating
Item
Patient is a woman who has a positive pregnancy test or is lactating.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
medical conditions
Item
Patient has clinically significant or unstable medical conditions which in the opinion of the investigator would render the patient unsuitable for the study (e.g. symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, etc.).
boolean
C0012634 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
non-compliant
Item
Patient who, in the opinion of the Investigator, would be non-compliant with the visit schedule or other study procedures.
boolean
C1321605 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
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