ID
25151
Description
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
Keywords
Versions (1)
- 8/27/17 8/27/17 -
Copyright Holder
gsk
Uploaded on
August 27, 2017
DOI
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License
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
Description
VITAL SIGNS
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
integer
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Blood pressure Semi-Supine
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0038846
Description
Blood pressure Standing position
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0231472
Description
Heart rate standing position
Data type
integer
Measurement units
- beats/minute
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0231472
Description
Heart rate Semi-Supine
Data type
integer
Measurement units
- beats/minute
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0038846
Description
RLS DIAGNOSTIC CLINICAL INTERVIEW - WORKSHEET
Description
Final diagnosis
Data type
integer
Alias
- UMLS CUI [1]
- C0011900
Description
Does subject report growing pains:
Data type
boolean
Alias
- UMLS CUI [1]
- C0423693
Description
If no, go to #3
Data type
boolean
Alias
- UMLS CUI [1]
- C2112857
Description
Are these feelings painful rather than just uncomfortable?
Data type
boolean
Alias
- UMLS CUI [1]
- C0030193
- UMLS CUI [2]
- C2051418
Description
How would you describe these feelings or sensations?
Data type
text
Alias
- UMLS CUI [1,1]
- C0036659
- UMLS CUI [1,2]
- C0678257
Description
If yes, go to #3a. If no, go to #4.
Data type
boolean
Alias
- UMLS CUI [1]
- C4289280
Description
Do these feelings in your legs ever become overwhelming to the point that you cannot resist moving your legs?
Data type
boolean
Alias
- UMLS CUI [1]
- C0030193
Description
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?:
Data type
boolean
Alias
- UMLS CUI [1]
- C0560841
Description
ALCOHOL INTAKE
Description
CAFFEINE INTAKE INVEST/GA TOR INSTRUCTIONS
Description
RLS SCREEN HISTORY
Description
What was the subject's age at the onset of RLS?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0206132
- UMLS CUI [1,2]
- C0035258
Description
If 'Yes' specify medication(s)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0420250
Description
If female, did RLS symptoms develop during pregnancy?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0032961
Description
Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of RLS?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0080103
Description
If 'YES', what was the subject's age at the onset of PLMS?
Data type
boolean
Alias
- UMLS CUI [1]
- C1970020
Description
Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of PLMS?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1970020
- UMLS CUI [1,2]
- C0080103
Description
If 'Yes' record on the Medical Conditions page.
Data type
boolean
Alias
- UMLS CUI [1]
- C0851578
Description
When are the subject's current RLS symptoms mainly present?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C1457887
Description
Have any of the following parts of the subject's body ever been affected by RLS symptoms?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0035258
Description
Does the subject consume alcohol?
Data type
boolean
Alias
- UMLS CUI [1]
- C0001948
Description
If Yes, record the average number of units of alcohol' consumed per week
Data type
text
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0556331
Description
Does the subject consume caffeine (coffee, tea, other caffeinated substances)?
Data type
boolean
Alias
- UMLS CUI [1]
- C0948365
Description
INTERNATIONAL RESTLESS LEG SYNDROME STUDY GROUP (IRLSSG) DIAGNOSTIC CRITERIA
Description
An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0518561
- UMLS CUI [1,2]
- C0035258
Description
The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C3890554
Description
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.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0080331
- UMLS CUI [1,2]
- C0600080
Description
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.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3845371
Description
CARDIOVASCULAR MEDICAL HISTORY
Description
Myocardial infarction
Data type
integer
Alias
- UMLS CUI [1]
- C0027051
Description
Atherosclerosis
Data type
integer
Alias
- UMLS CUI [1]
- C0004153
Description
Cardiac valve disease
Data type
integer
Alias
- UMLS CUI [1]
- C0018824
Description
Peripheral vascular disease
Data type
integer
Alias
- UMLS CUI [1]
- C0085096
Description
Unspecified cerebrovascular disease
Data type
integer
Alias
- UMLS CUI [1]
- C0007820
Description
Transient ischaemic attack
Data type
integer
Alias
- UMLS CUI [1]
- C0007787
Description
Stroke
Data type
integer
Alias
- UMLS CUI [1]
- C0038454
Description
Cardiac arrest
Data type
integer
Alias
- UMLS CUI [1]
- C0018790
Description
Coronary artery disease
Data type
integer
Alias
- UMLS CUI [1]
- C1956346
Description
ischaemic heart disease
Data type
integer
Alias
- UMLS CUI [1]
- C0151744
Description
ischaemic heart disease with cardiomyopathy
Data type
integer
Alias
- UMLS CUI [1,1]
- C0151744
- UMLS CUI [1,2]
- C0878544
Description
Stable angina pectoris
Data type
integer
Alias
- UMLS CUI [1]
- C0340288
Description
Unstable angina
Data type
integer
Alias
- UMLS CUI [1]
- C0002965
Description
Heart failure
Data type
integer
Alias
- UMLS CUI [1]
- C0018801
Description
Arrhythmia
Data type
integer
Alias
- UMLS CUI [1]
- C0003811
Description
Left ventricular dysfunction
Data type
integer
Alias
- UMLS CUI [1]
- C0242698
Description
Pulmonary oedema
Data type
integer
Alias
- UMLS CUI [1]
- C0034063
Description
Hypertension
Data type
integer
Alias
- UMLS CUI [1]
- C0020538
Description
Oedema
Data type
text
Alias
- UMLS CUI [1]
- C0013604
Description
Left ventricular hypertrophy
Data type
integer
Alias
- UMLS CUI [1]
- C0149721
Description
Cardiomegaly
Data type
integer
Alias
- UMLS CUI [1]
- C0018800
Description
Cardiomyopathy
Data type
integer
Alias
- UMLS CUI [1]
- C0878544
Description
Diastolic dysfunction
Data type
integer
Alias
- UMLS CUI [1]
- C0520863
Description
Coronary artery by-pass
Data type
integer
Alias
- UMLS CUI [1]
- C0010055
Description
Angioplasty
Data type
integer
Alias
- UMLS CUI [1]
- C0162577
Description
STENT insertion
Data type
integer
Alias
- UMLS CUI [1]
- C0398087
Description
Cardiac transplantation
Data type
integer
Alias
- UMLS CUI [1]
- C3275052
Description
Amputation
Data type
integer
Alias
- UMLS CUI [1]
- C0002688
Description
Pacemaker insertion
Data type
integer
Alias
- UMLS CUI [1]
- C0189843
Description
Carotid endarterectomy
Data type
integer
Alias
- UMLS CUI [1]
- C3275052
Description
Vascular bypass graft (other than coronary)
Data type
integer
Alias
- UMLS CUI [1]
- C0863745
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DEMOGRAPHY Ropinirole Case Report Form GSK
- StudyEvent: ODM
C0038846 (UMLS CUI [1,2])
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C0080103 (UMLS CUI [1,2])
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