ID
25151
Beschrijving
DEMOGRAPHY Ropinirole Case Report Form GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage
Trefwoorden
Versies (1)
- 27-08-17 27-08-17 -
Houder van rechten
gsk
Geüploaded op
27 augustus 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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DEMOGRAPHY Ropinirole Case Report Form GSK RRL100013
DEMOGRAPHY Ropinirole Case Report Form GSK
- StudyEvent: ODM
Beschrijving
VITAL SIGNS
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
integer
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Blood pressure Semi-Supine
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0038846
Beschrijving
Blood pressure Standing position
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0231472
Beschrijving
Heart rate standing position
Datatype
integer
Maateenheden
- beats/minute
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0231472
Beschrijving
Heart rate Semi-Supine
Datatype
integer
Maateenheden
- beats/minute
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0038846
Beschrijving
RLS DIAGNOSTIC CLINICAL INTERVIEW - WORKSHEET
Beschrijving
Final diagnosis
Datatype
integer
Alias
- UMLS CUI [1]
- C0011900
Beschrijving
Does subject report growing pains:
Datatype
boolean
Alias
- UMLS CUI [1]
- C0423693
Beschrijving
Have you ever had unpleasant or uncomfortable feelings in your legs that occurred mainly while you were either sitting or lying down?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2112857
Beschrijving
Are these feelings painful rather than just uncomfortable?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0030193
- UMLS CUI [2]
- C2051418
Beschrijving
How would you describe these feelings or sensations?
Datatype
text
Alias
- UMLS CUI [1,1]
- C0036659
- UMLS CUI [1,2]
- C0678257
Beschrijving
Have you ever felt the need or urge to move your legs that occurred mainly while you were either sitting or lying down?
Datatype
boolean
Alias
- UMLS CUI [1]
- C4289280
Beschrijving
Do these feelings in your legs ever become overwhelming to the point that you cannot resist moving your legs?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0030193
Beschrijving
If you developed these feelings in your legs and you could not move your legs, or if someone were to hold your legs down, how would this effect the feelings in your legs?:
Datatype
boolean
Alias
- UMLS CUI [1]
- C0560841
Beschrijving
ALCOHOL INTAKE
Beschrijving
CAFFEINE INTAKE INVEST/GA TOR INSTRUCTIONS
Beschrijving
RLS SCREEN HISTORY
Beschrijving
What was the subject's age at the onset of RLS?
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0206132
- UMLS CUI [1,2]
- C0035258
Beschrijving
Did the subject start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0420250
Beschrijving
If female, did RLS symptoms develop during pregnancy?
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0032961
Beschrijving
Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of RLS?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0080103
Beschrijving
Has the subject ever had PLMS (Periodic Limb Movements during Sleep)?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1970020
Beschrijving
Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of PLMS?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1970020
- UMLS CUI [1,2]
- C0080103
Beschrijving
Does the subject have any sleep disorder as defined by DSM IV other than qualifying disease state for this study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0851578
Beschrijving
When are the subject's current RLS symptoms mainly present?
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C1457887
Beschrijving
Have any of the following parts of the subject's body ever been affected by RLS symptoms?
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0035258
Beschrijving
Does the subject consume alcohol?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschrijving
If Yes, record the average number of units of alcohol' consumed per week
Datatype
text
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0556331
Beschrijving
Does the subject consume caffeine (coffee, tea, other caffeinated substances)?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0948365
Beschrijving
INTERNATIONAL RESTLESS LEG SYNDROME STUDY GROUP (IRLSSG) DIAGNOSTIC CRITERIA
Beschrijving
An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0518561
- UMLS CUI [1,2]
- C0035258
Beschrijving
The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C3890554
Beschrijving
The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0080331
- UMLS CUI [1,2]
- C0600080
Beschrijving
The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3845371
Beschrijving
CARDIOVASCULAR MEDICAL HISTORY
Beschrijving
Myocardial infarction
Datatype
integer
Alias
- UMLS CUI [1]
- C0027051
Beschrijving
Atherosclerosis
Datatype
integer
Alias
- UMLS CUI [1]
- C0004153
Beschrijving
Cardiac valve disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0018824
Beschrijving
Peripheral vascular disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0085096
Beschrijving
Unspecified cerebrovascular disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0007820
Beschrijving
Transient ischaemic attack
Datatype
integer
Alias
- UMLS CUI [1]
- C0007787
Beschrijving
Stroke
Datatype
integer
Alias
- UMLS CUI [1]
- C0038454
Beschrijving
Cardiac arrest
Datatype
integer
Alias
- UMLS CUI [1]
- C0018790
Beschrijving
Coronary artery disease
Datatype
integer
Alias
- UMLS CUI [1]
- C1956346
Beschrijving
ischaemic heart disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0151744
Beschrijving
ischaemic heart disease with cardiomyopathy
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0151744
- UMLS CUI [1,2]
- C0878544
Beschrijving
Stable angina pectoris
Datatype
integer
Alias
- UMLS CUI [1]
- C0340288
Beschrijving
Unstable angina
Datatype
integer
Alias
- UMLS CUI [1]
- C0002965
Beschrijving
Heart failure
Datatype
integer
Alias
- UMLS CUI [1]
- C0018801
Beschrijving
Arrhythmia
Datatype
integer
Alias
- UMLS CUI [1]
- C0003811
Beschrijving
Left ventricular dysfunction
Datatype
integer
Alias
- UMLS CUI [1]
- C0242698
Beschrijving
Pulmonary oedema
Datatype
integer
Alias
- UMLS CUI [1]
- C0034063
Beschrijving
Hypertension
Datatype
integer
Alias
- UMLS CUI [1]
- C0020538
Beschrijving
Oedema
Datatype
text
Alias
- UMLS CUI [1]
- C0013604
Beschrijving
Left ventricular hypertrophy
Datatype
integer
Alias
- UMLS CUI [1]
- C0149721
Beschrijving
Cardiomegaly
Datatype
integer
Alias
- UMLS CUI [1]
- C0018800
Beschrijving
Cardiomyopathy
Datatype
integer
Alias
- UMLS CUI [1]
- C0878544
Beschrijving
Diastolic dysfunction
Datatype
integer
Alias
- UMLS CUI [1]
- C0520863
Beschrijving
Coronary artery by-pass
Datatype
integer
Alias
- UMLS CUI [1]
- C0010055
Beschrijving
Angioplasty
Datatype
integer
Alias
- UMLS CUI [1]
- C0162577
Beschrijving
STENT insertion
Datatype
integer
Alias
- UMLS CUI [1]
- C0398087
Beschrijving
Cardiac transplantation
Datatype
integer
Alias
- UMLS CUI [1]
- C3275052
Beschrijving
Amputation
Datatype
integer
Alias
- UMLS CUI [1]
- C0002688
Beschrijving
Pacemaker insertion
Datatype
integer
Alias
- UMLS CUI [1]
- C0189843
Beschrijving
Carotid endarterectomy
Datatype
integer
Alias
- UMLS CUI [1]
- C3275052
Beschrijving
Vascular bypass graft (other than coronary)
Datatype
integer
Alias
- UMLS CUI [1]
- C0863745
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- StudyEvent: ODM
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