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26102
Beschreibung
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from 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: Restless Legs Syndrome This is the Screening form.
Stichworte
Versionen (2)
- 09.10.17 09.10.17 -
- 18.10.17 18.10.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
9. Oktober 2017
DOI
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Creative Commons BY-NC 3.0
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GSK Ropinirole in Patients Suffering from Restless Legs Syndrome Screening 101468/190
GSK Ropinirole in Patients Suffering from Restless Legs Syndrome Screening 101468/190
Ähnliche Modelle
GSK Ropinirole in Patients Suffering from Restless Legs Syndrome Screening 101468/190
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
C1955348 (UMLS CUI-2)
C0035258 (UMLS CUI-3)
C1955348 (UMLS CUI-2)
C0035258 (UMLS CUI-3)
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
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
Item
How old was the patient at the onset of RLS? <<> Years (in whole years)
integer
C0001779 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
new medication
Item
Did the patient start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
boolean
C0013227 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205314 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
new medication
Item
If ’Yes’ please specify medication(s)
text
C0013227 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205314 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Item
If female, did RLS symptoms develop during pregnancy?
integer
C0032961 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
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
C1970020 (UMLS CUI [1])
PLMS age
Item
How old was the patient at the onset of PLMS?
integer
C1970020 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,2])
alcohol
Item
Does the patient drink alcohol?
boolean
C0001948 (UMLS CUI [1])
Units/week
Item
Units/week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
C0560579 (UMLS CUI [1,2])
caffeine
Item
Does the patient drink caffeine (coffee, tea, caffeinated drinks)?
boolean
C0006644 (UMLS CUI [1])
Cups/day
Item
Cups/day
integer
C0006644 (UMLS CUI [1])
DSM IV sleep disorder
Item
Does the patient have any sleep disorder as defined by DSM IV?
boolean
C0220952 (UMLS CUI [1,1])
C0851578 (UMLS CUI [1,2])
C0851578 (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])
C0035258 (UMLS CUI [1,2])
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
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever ... been diagnosed with or had symptoms of PLMS?
integer
C1517194 (UMLS CUI [1,1])
C1970020 (UMLS CUI [1,2])
C1970020 (UMLS CUI [1,2])
Code List
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever ... been diagnosed with or had symptoms of PLMS?
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])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
CL Item
At nightime only (1)
CL Item
In evening and nightime (2)
CL Item
Daytime, evening and nightime (3)
limb movement
Item
The International RLS Study Group Criteria* defines RLS patients as having: a desire to move the limbs usually associated with paresthesias or dysesthesias
boolean
C0035258 (UMLS CUI [1,1])
C0596840 (UMLS CUI [1,2])
C0030554 (UMLS CUI [1,3])
C0392699 (UMLS CUI [1,4])
C0596840 (UMLS CUI [1,2])
C0030554 (UMLS CUI [1,3])
C0392699 (UMLS CUI [1,4])
motor restlessness
Item
The International RLS Study Group Criteria* defines RLS patients as having: motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort)
boolean
C0700075 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
relief by activity
Item
The International RLS Study Group Criteria* defines RLS patients as having: symptoms worse or exclusively present at rest with at least partial and temporal relief by activity
boolean
C0035258 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
C0564405 (UMLS CUI [1,3])
C0026606 (UMLS CUI [1,2])
C0564405 (UMLS CUI [1,3])
symptoms worse in the evening or night
Item
The International RLS Study Group Criteria* defines RLS patients as having: symptoms worse in the evening or night
boolean
C3176727 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
CL Item
White (1)
CL Item
Black (2)
CL Item
Oriental (3)
CL Item
Other (4)
Race
Item
Race Other, specify:
text
C0034510 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Sitting Blood Pressure
Item
Sitting Blood Pressure (after 5 minutes sitting) systolic / diastolic
text
C0580946 (UMLS CUI [1])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Were any clinically significant abnormalities detected?
integer
C1704258 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Yes -> If `Yes`, please record details in the Adverse Experiences and/or SAE section at the back of this book. (2)
physical examination
Item
Please perform a full physical examination and record any clinically significant abnormality on the Significant Medical/Surgical History and Physical Examination Page.
boolean
C0031809 (UMLS CUI [1])
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Were any clinically significant abnormalities detected?
integer
Code List
Were any clinically significant abnormalities detected?
CL Item
No (1)
CL Item
Yes -> If `yes`, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and repeat prior to baseline. (2)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1])
CL Item
Negative (1)
CL Item
Positive - If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and send a sample to Quest Diagnostics for further evaluation. (2)
child-bearing potential
Item
Is the patient a female of child-bearing potential?
boolean
C1960468 (UMLS CUI [1])
CL Item
Negative (1)
CL Item
Positive - If ’Positive’, please record details on the Significant Medical/ Surgical History and Physical Examination and exclude the patient. (2)
Item Group
SIGNIFICANT MEDICAL/SURGICAL HISTORY AND PHYSICAL EXAMINATION
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Item
Is the patient suffering from or has he/she ever suffered from any significant medical or surgical condition?
integer
C0543467 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
Code List
Is the patient suffering from or has he/she ever suffered from any significant medical or surgical condition?
CL Item
No (1)
CL Item
Yes - If 'Yes' , please list below one diagnosis per line. (Please print clearly) (2)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis (if known)
Item
Year of first diagnosis (if known)
integer
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Past
Item
Past
boolean
C0455458 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C2826680 (UMLS CUI [1])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis (if known)
Item
Year of first diagnosis (if known)
integer
C0011900 (UMLS CUI [1,1])
Past
Item
Past
boolean
C0455458 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C2826680 (UMLS CUI [1])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis (if known)
Item
Year of first diagnosis (if known)
integer
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Past
Item
Past
boolean
C0455458 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C2826680 (UMLS CUI [1])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis (if known)
Item
Year of first diagnosis (if known)
integer
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Past
Item
Past
boolean
C0455458 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C2826680 (UMLS CUI [1])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis (if known)
Item
Year of first diagnosis (if known)
integer
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Past
Item
Past
boolean
C0455458 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C2826680 (UMLS CUI [1])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis (if known)
Item
Year of first diagnosis (if known)
integer
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Past
Item
Past
boolean
C0455458 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C2826680 (UMLS CUI [1])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis (if known)
Item
Year of first diagnosis (if known)
integer
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Past
Item
Past
boolean
C0455458 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C2826680 (UMLS CUI [1])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis (if known)
Item
Year of first diagnosis (if known)
integer
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Past
Item
Past
boolean
C0455458 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C2826680 (UMLS CUI [1])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis (if known)
Item
Year of first diagnosis (if known)
integer
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Past
Item
Past
boolean
C0455458 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C2826680 (UMLS CUI [1])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis (if known)
Item
Year of first diagnosis (if known)
integer
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Past
Item
Past
boolean
C0455458 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C2826680 (UMLS CUI [1])
Item Group
PRIOR AND CONCOMITANT MEDICATION
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Item
Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS) in the 3 months prior to study entry?
integer
C0013227 (UMLS CUI [1])
Code List
Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS) in the 3 months prior to study entry?
CL Item
No (1)
CL Item
Yes If ‘Yes’, please record details below (Please print clearly) Medical indications recorded here must correlate with either: diagnoses (or symptoms) listed in the Significant Medical/Surgical History and Physical Examination section OR a documented baseline adverse experience prior to receiving double-blind or active medication and must be expressed using the same terminology. (2)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2826638 (UMLS CUI [1])
Medical Illness/ Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C2826666 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2826638 (UMLS CUI [1])
Medical Illness/ Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C2826666 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2826638 (UMLS CUI [1])
Medical Illness/ Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C2826666 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2826638 (UMLS CUI [1])
Medical Illness/ Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C2826666 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2826638 (UMLS CUI [1])
Medical Illness/ Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2826638 (UMLS CUI [1])
Medical Illness/ Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2826638 (UMLS CUI [1])
Medical Illness/ Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2826638 (UMLS CUI [1])
Medical Illness/ Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2826638 (UMLS CUI [1])
Medical Illness/ Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2826638 (UMLS CUI [1])
Medical Illness/ Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
Item Group
RLS PHARMACOTHERAPY HISTORY
C0013216 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
C0035258 (UMLS CUI-2)
Item
Has the patient taken any pharmacotherapy medication for treatment of RLS?
integer
C0013216 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Yes - If ‘Yes’, please record details below (Please print clearly) (2)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Continuing
Item
Continuing
boolean
C1553904 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Item
Did the patient respond to the treatment?
integer
C0521982 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Did the patient tolerate the treatment?
integer
C0039798 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Continuing
Item
Continuing
boolean
C1553904 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Item
Did the patient respond to the treatment?
integer
C0521982 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Did the patient tolerate the treatment?
integer
C0039798 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Continuing
Item
Continuing
boolean
C1553904 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Item
Did the patient respond to the treatment?
integer
C0521982 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Did the patient tolerate the treatment?
integer
C0039798 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Continuing
Item
Continuing
boolean
C1553904 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Item
Did the patient respond to the treatment?
integer
C0521982 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Did the patient tolerate the treatment?
integer
C0039798 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Continuing
Item
Continuing
boolean
C1553904 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Item
Did the patient respond to the treatment?
integer
C0521982 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Did the patient tolerate the treatment?
integer
C0039798 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0013216 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item Group
SCREENING INCLUSION/EXCLUSION CRITERIA
C1512693 (UMLS CUI-1)
C0680251 (UMLS CUI-2)
C0220908 (UMLS CUI-3)
C0680251 (UMLS CUI-2)
C0220908 (UMLS CUI-3)
RLS diagnosis
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 [1,1])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Patient age
Item
Patient is > 18 years old and < 80 years of age.
boolean
C0035258 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,2])
informed consent
Item
Patient has given written informed consent prior to any specific study procedures.
boolean
C0035258 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
rls daytime syndromes
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])
C0035258 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0332169 (UMLS CUI [1,4])
C0035258 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0332169 (UMLS CUI [1,4])
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
C0035258 (UMLS CUI [1,1])
C0236991 (UMLS CUI [1,2])
C0236991 (UMLS CUI [1,2])
movement disorder
Item
Patient is suffering from a movement disorder (e.g. Parkinson's Disease, dyskinesias or dystonias).
boolean
C0035258 (UMLS CUI [1,1])
C0026650 (UMLS CUI [1,2])
C0026650 (UMLS CUI [1,2])
medical conditions with symptoms
Item
Patient has medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, etc.).
boolean
C0035258 (UMLS CUI [1,1])
C1699700 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C1699700 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
intolerance to ropinirole
Item
Patient has exhibited intolerance to ropinirole or any other dopamine agonist.
boolean
C0035258 (UMLS CUI [1,1])
C1744706 (UMLS CUI [1,2])
C0178601 (UMLS CUI [1,3])
C1744706 (UMLS CUI [1,2])
C0178601 (UMLS CUI [1,3])
substance abuse
Item
Patient meets DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 6 months prior to Screening.
boolean
C0035258 (UMLS CUI [1,1])
C0740858 (UMLS CUI [1,2])
C0740858 (UMLS CUI [1,2])
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
C0035258 (UMLS CUI [1,1])
C0009862 (UMLS CUI [1,2])
C0009862 (UMLS CUI [1,2])
pregnancy or lactating
Item
Patient is a woman who has a positive pregnancy test or is lactating.
boolean
C0035258 (UMLS CUI [1,1])
C2828358 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C2828358 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
unstable 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
C0035258 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0018684 (UMLS CUI [1,3])
C0443343 (UMLS CUI [1,2])
C0018684 (UMLS CUI [1,3])
compliance
Item
Patient who, in the opinion of the Investigator, would be non-compliant with the visit schedule or other study procedures.
boolean
C0035258 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
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