ID
25151
Beskrivning
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
Nyckelord
Versioner (1)
- 2017-08-27 2017-08-27 -
Rättsinnehavare
gsk
Uppladdad den
27 augusti 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
DEMOGRAPHY Ropinirole Case Report Form GSK RRL100013
DEMOGRAPHY Ropinirole Case Report Form GSK
- StudyEvent: ODM
Beskrivning
VITAL SIGNS
Beskrivning
Height
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Weight
Datatyp
integer
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Blood pressure Semi-Supine
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0038846
Beskrivning
Blood pressure Standing position
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0231472
Beskrivning
Heart rate standing position
Datatyp
integer
Måttenheter
- beats/minute
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0231472
Beskrivning
Heart rate Semi-Supine
Datatyp
integer
Måttenheter
- beats/minute
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0038846
Beskrivning
RLS DIAGNOSTIC CLINICAL INTERVIEW - WORKSHEET
Beskrivning
Final diagnosis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0011900
Beskrivning
Does subject report growing pains:
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0423693
Beskrivning
Have you ever had unpleasant or uncomfortable feelings in your legs that occurred mainly while you were either sitting or lying down?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2112857
Beskrivning
Are these feelings painful rather than just uncomfortable?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0030193
- UMLS CUI [2]
- C2051418
Beskrivning
How would you describe these feelings or sensations?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0036659
- UMLS CUI [1,2]
- C0678257
Beskrivning
Have you ever felt the need or urge to move your legs that occurred mainly while you were either sitting or lying down?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C4289280
Beskrivning
Do these feelings in your legs ever become overwhelming to the point that you cannot resist moving your legs?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0030193
Beskrivning
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?:
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0560841
Beskrivning
ALCOHOL INTAKE
Beskrivning
CAFFEINE INTAKE INVEST/GA TOR INSTRUCTIONS
Beskrivning
RLS SCREEN HISTORY
Beskrivning
What was the subject's age at the onset of RLS?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0206132
- UMLS CUI [1,2]
- C0035258
Beskrivning
Did the subject start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0420250
Beskrivning
If female, did RLS symptoms develop during pregnancy?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0032961
Beskrivning
Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of RLS?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0080103
Beskrivning
Has the subject ever had PLMS (Periodic Limb Movements during Sleep)?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1970020
Beskrivning
Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of PLMS?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1970020
- UMLS CUI [1,2]
- C0080103
Beskrivning
Does the subject have any sleep disorder as defined by DSM IV other than qualifying disease state for this study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0851578
Beskrivning
When are the subject's current RLS symptoms mainly present?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C1457887
Beskrivning
Have any of the following parts of the subject's body ever been affected by RLS symptoms?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0035258
Beskrivning
Does the subject consume alcohol?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beskrivning
If Yes, record the average number of units of alcohol' consumed per week
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0556331
Beskrivning
Does the subject consume caffeine (coffee, tea, other caffeinated substances)?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0948365
Beskrivning
INTERNATIONAL RESTLESS LEG SYNDROME STUDY GROUP (IRLSSG) DIAGNOSTIC CRITERIA
Beskrivning
An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0518561
- UMLS CUI [1,2]
- C0035258
Beskrivning
The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C3890554
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0080331
- UMLS CUI [1,2]
- C0600080
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3845371
Beskrivning
CARDIOVASCULAR MEDICAL HISTORY
Beskrivning
Myocardial infarction
Datatyp
integer
Alias
- UMLS CUI [1]
- C0027051
Beskrivning
Atherosclerosis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0004153
Beskrivning
Cardiac valve disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018824
Beskrivning
Peripheral vascular disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0085096
Beskrivning
Unspecified cerebrovascular disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0007820
Beskrivning
Transient ischaemic attack
Datatyp
integer
Alias
- UMLS CUI [1]
- C0007787
Beskrivning
Stroke
Datatyp
integer
Alias
- UMLS CUI [1]
- C0038454
Beskrivning
Cardiac arrest
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018790
Beskrivning
Coronary artery disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C1956346
Beskrivning
ischaemic heart disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0151744
Beskrivning
ischaemic heart disease with cardiomyopathy
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0151744
- UMLS CUI [1,2]
- C0878544
Beskrivning
Stable angina pectoris
Datatyp
integer
Alias
- UMLS CUI [1]
- C0340288
Beskrivning
Unstable angina
Datatyp
integer
Alias
- UMLS CUI [1]
- C0002965
Beskrivning
Heart failure
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018801
Beskrivning
Arrhythmia
Datatyp
integer
Alias
- UMLS CUI [1]
- C0003811
Beskrivning
Left ventricular dysfunction
Datatyp
integer
Alias
- UMLS CUI [1]
- C0242698
Beskrivning
Pulmonary oedema
Datatyp
integer
Alias
- UMLS CUI [1]
- C0034063
Beskrivning
Hypertension
Datatyp
integer
Alias
- UMLS CUI [1]
- C0020538
Beskrivning
Oedema
Datatyp
text
Alias
- UMLS CUI [1]
- C0013604
Beskrivning
Left ventricular hypertrophy
Datatyp
integer
Alias
- UMLS CUI [1]
- C0149721
Beskrivning
Cardiomegaly
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018800
Beskrivning
Cardiomyopathy
Datatyp
integer
Alias
- UMLS CUI [1]
- C0878544
Beskrivning
Diastolic dysfunction
Datatyp
integer
Alias
- UMLS CUI [1]
- C0520863
Beskrivning
Coronary artery by-pass
Datatyp
integer
Alias
- UMLS CUI [1]
- C0010055
Beskrivning
Angioplasty
Datatyp
integer
Alias
- UMLS CUI [1]
- C0162577
Beskrivning
STENT insertion
Datatyp
integer
Alias
- UMLS CUI [1]
- C0398087
Beskrivning
Cardiac transplantation
Datatyp
integer
Alias
- UMLS CUI [1]
- C3275052
Beskrivning
Amputation
Datatyp
integer
Alias
- UMLS CUI [1]
- C0002688
Beskrivning
Pacemaker insertion
Datatyp
integer
Alias
- UMLS CUI [1]
- C0189843
Beskrivning
Carotid endarterectomy
Datatyp
integer
Alias
- UMLS CUI [1]
- C3275052
Beskrivning
Vascular bypass graft (other than coronary)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0863745
Similar models
DEMOGRAPHY Ropinirole Case Report Form GSK
- StudyEvent: ODM
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0231472 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C0439544 (UMLS CUI-2)
(Comment:en)
C0332148 (UMLS CUI-2)
(Comment:en)
C2362652 (UMLS CUI-2)
(Comment:en)
C0497153 (UMLS CUI-2)
(Comment:en)
C0439544 (UMLS CUI-2)
C0332138 (UMLS CUI-3)
(Comment:en)
C2362652 (UMLS CUI-2)
C0332138 (UMLS CUI-3)
(Comment:en)
C0439673 (UMLS CUI-2)
(Comment:en)
C2051418 (UMLS CUI [2])
C0678257 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
C0420250 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
C0080103 (UMLS CUI [1,2])
C0080103 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
(Comment:en)
C0587117 (UMLS CUI-2)
(Comment:en)
C0587117 (UMLS CUI-2)
C0332169 (UMLS CUI-3)
(Comment:en)
C0035258 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0027530 (UMLS CUI-3)
(Comment:en)
C0556331 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
C3890554 (UMLS CUI [1,2])
C0600080 (UMLS CUI [1,2])
C3845371 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0878544 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
C0012634 (UMLS CUI-2)
(Comment:en)
(Comment:en)