Informazione: Questa è una versione obsoleta del modello di dati. È possibile accedere alla versione corrente tramite Versioni a sinistra.
Informazione:
Errore:
ID
39013
Descrizione
Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease
Keywords
versioni (2)
- 20/11/19 20/11/19 -
- 09/01/20 09/01/20 -
Titolare del copyright
GlaxoSmithKline
Caricato su
20 novembre 2019
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY-NC 3.0
Commenti del modello :
Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.
Commenti del gruppo di articoli per :
Commenti dell'articolo per :
Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.
Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease
Screening - Consent Demographics; Central Laboratory; Dermatological Neurological Exam; ECG
Similar models
Screening - Consent Demographics; Central Laboratory; Dermatological Neurological Exam; ECG
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Study Name
Item
Study Name
text
C2348560 (UMLS CUI [1])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Study Site
Item
Study Site
text
C2825164 (UMLS CUI [1])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Date of Informed Consent
Item
Date of Informed Consent
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Female (F)
CL Item
Male (M)
CL Item
Pre-menarcheal (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Final menses - Complete Date Unknown
integer
C0425932 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
CL Item
Complete Date Unknown (1)
Date of final menses
Item
Date of final menses
date
C0425932 (UMLS CUI [1])
Item
Became sterile - Complete Date Unknown
text
C0021359 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
CL Item
Complete Date Unknown (1)
Date became sterile
Item
Date became sterile
date
C0021359 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Abstinence (1)
CL Item
Oral contraception (2)
CL Item
Injectable progestogen (3)
CL Item
Implants of levonorgestrel (4)
CL Item
Estrogenic vaginal ring (5)
CL Item
Percutaneous contraceptive patches (6)
CL Item
Male partner sterilization (7)
CL Item
Intrauterine device (IUD) (8)
CL Item
Double barrier method; condom or occlusive cap plus spermicidal agent (9)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/ South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/ North African Heritage (8)
CL Item
White- White/ Caucasian/ European Heritage (9)
Item Group
Central Laboratory
C1880016 (UMLS CUI-1)
C0745590 (UMLS CUI-2)
C1705822 (UMLS CUI-3)
C0745590 (UMLS CUI-2)
C1705822 (UMLS CUI-3)
CL Item
Haematology (1)
CL Item
Clinical Chemistry (2)
CL Item
Urinalysis (3)
Sample collection date
Item
Sample collection date
date
C1302413 (UMLS CUI [1])
Sample collection time
Item
Sample collection time
time
C0040223 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
Item
Laboratory Test not done
integer
C0022885 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
CL Item
Not done (1)
Item Group
Central Laboratory - Possible Liver Events
C1880016 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0332149 (UMLS CUI-4)
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0332149 (UMLS CUI-4)
Was there a protocol defined Liver Chemistry Event for the lab samples collected at this visit?
Item
Was there a protocol defined Liver Chemistry Event for the lab samples collected at this visit?
boolean
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
Date of dermatological exam
Item
Date of dermatological exam
date
C0031809 (UMLS CUI [1,1])
C0011627 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0011627 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Dermatological Exam not done
integer
C0031809 (UMLS CUI [1,1])
C0011627 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0011627 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
CL Item
Not done (1)
Upon examination, were any abnormalities present?
Item
Upon examination, were any abnormalities present?
boolean
C0031809 (UMLS CUI [1,1])
C0560169 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0560169 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Was subject referred to dermatologist?
Item
Was subject referred to dermatologist?
boolean
C2585021 (UMLS CUI [1,1])
C0259831 (UMLS CUI [1,2])
C0259831 (UMLS CUI [1,2])
Reason dermatologist was not consulted
Item
Reason dermatologist was not consulted
text
C0259831 (UMLS CUI [1,1])
C0009818 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0009818 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
Date of consult
Item
Date of consult
date
C0259831 (UMLS CUI [1,1])
C0009818 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0009818 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
What were the findings from consultation?
Item
What were the findings from consultation?
text
C0259831 (UMLS CUI [1,1])
C0009818 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0009818 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Date of neurological exam
Item
Date of neurological exam
date
C0027853 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Neurological examination not done
integer
C0027853 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
CL Item
Not done (1)
CL Item
Mental status (1)
CL Item
Gait (2)
CL Item
Balance (3)
CL Item
Coordination (4)
CL Item
Cranial nerves (5)
CL Item
Motor (6)
CL Item
Reflexes (7)
CL Item
Sensory (8)
CL Item
Muscle Tone - Hypertonia (9)
CL Item
10 Muscle Tone - Hypotonia (10 Muscle Tone - Hypotonia)
Item
Neurological abnormalities
integer
C0027853 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Neurological Exam - Intensity/ Abnormal
integer
C0027853 (UMLS CUI [1])
C0518690 (UMLS CUI [2])
C0205161 (UMLS CUI [3])
C0518690 (UMLS CUI [2])
C0205161 (UMLS CUI [3])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Was the neurological examination consistent with the diagnosis of Parkinson's disease?
Item
Was the neurological examination consistent with the diagnosis of Parkinson's disease?
boolean
C0027853 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C0030567 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
Was ECG Performed?
Item
Was ECG Performed?
boolean
C0430456 (UMLS CUI [1])
Date and time of ECG
Item
Date and time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (2)
Record the RR interval that precedes the measured QT interval
Item
Record the RR interval that precedes the measured QT interval
integer
C0489636 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,3])
Item
RR interval not available
integer
C0489636 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,2])
CL Item
RR interval not available (1)
CL Item
QTcB (Bazett) (1)
QTcB (Bazett) finding
Item
QTcB (Bazett) finding
integer
C1882512 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
CL Item
QTcF (Fridericia) (1)
QTcF (Fridericia) finding
Item
QTcF (Fridericia) finding
integer
C1882513 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
Item
QTc Interval, other method of correction
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
CL Item
QTc Interval, other method of correction (1)
Is this a repeat ECG?
Item
Is this a repeat ECG?
boolean
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
Item
Specify reason ECG repeated
integer
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
CL Item
Safety (1)
CL Item
Other (2)
Specify other reason ECG repeated
Item
Specify other reason ECG repeated
text
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0205341 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
CL Item
Normal (1)
CL Item
Abnormal, not clinically significant (2)
CL Item
Abnormal, clinically significant (3)
CL Item
No result (not available) (4)
CL Item
Sinus arrhythmia (1)
CL Item
Sinus bradycardia (2)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (3)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (4)
CL Item
Sinus bradycardia (heart rate <30 beats/min) (5)
CL Item
Sinus pause (6)
CL Item
Sinus tachycardia (heart rate > 100 beats/min) (7)
CL Item
Ectopic supraventricular beats (8)
CL Item
Ectopic supraventricular rhythm (9)
CL Item
Wandering atrial pacemaker (10)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (11)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (12)
CL Item
Atrial flutter (13)
CL Item
Atrial fibrillation (14)
CL Item
Junctional rhythm (heart rate <=100 beats/min) (15)
CL Item
Junctional rhythm (16)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (17)
CL Item
Ectopic ventricular beats (18)
CL Item
Ventricular couplets (19)
CL Item
Bigeminy (20)
CL Item
Trigeminy (21)
CL Item
Electrical alternans (22)
CL Item
R on T phenomenon (23)
CL Item
Ventricular fibrillation (24)
CL Item
Idioventricular Rhythm - heart rate <100 beats/min (25)
CL Item
Sustained ventricular tachycardia (26)
CL Item
Non-sustained ventricular tachycardia (27)
CL Item
Wide QRS Tachycardia (diagnosis unknown) (28)
CL Item
Ventricular tachycardia (29)
CL Item
Monomorphic ventricular tachycardia (30)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (31)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (32)
CL Item
Artificial Pacemaker (33)
CL Item
Junctional escape complexes (34)
CL Item
Other rhythm (35)
Specify other rhythm
Item
Specify other rhythm
text
C0232187 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CL Item
Poor R wave progression (1)
CL Item
Left atrial abnormality (2)
CL Item
Right atrial abnormality (3)
CL Item
Right ventricular hypertrophy (4)
CL Item
Intraatrial conduction delay (5)
CL Item
Late R wave transition (6)
CL Item
Increased voltage consistent with left ventricular hypertrophy (7)
CL Item
Other morphology (8)
Specify other ther P-Wave Morphology
Item
Specify other ther P-Wave Morphology
text
C2216025 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CL Item
First degree AV block (PR interval > 200msec) (1)
CL Item
Short PR Interval (2)
CL Item
Second degree AV block (Mobitz type 1) (3)
CL Item
Second degree AV block (Mobitz type 2) (4)
CL Item
2:1 AV block (5)
CL Item
Third degree AV block (6)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (7)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (8)
CL Item
Incomplete right bundle branch block (9)
CL Item
Incomplete left bundle branch block (10)
CL Item
Right bundle branch block (11)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (12)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (13)
CL Item
Left bundle branch block (14)
CL Item
Bifascicular block (15)
CL Item
Non-specific intraventricular conduction delay (QRS > 120 msec) (16)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (17)
CL Item
AV dissociation (18)
CL Item
Prolonged QT 450-500 (19)
CL Item
Prolonged QT >500 (20)
CL Item
Prolonged QTc Interval 450-500 (21)
CL Item
Prolonged QTc Interval >500 (22)
CL Item
Other conduction (23)
Specify other conduction
Item
Specify other conduction
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, anterior (2)
CL Item
Myocardial infarction, lateral (3)
CL Item
Myocardial infarction, posterior (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal (6)
CL Item
Myocardial infarction, Non Q-wave (7)
CL Item
Other myocardial infarction (8)
Specify other myocardial infarction
Item
Specify other myocardial infarction
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Depolarisation/Repolarisation (QRS-T)
integer
C1331539 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
C0948857 (UMLS CUI [1,2])
CL Item
Non-specific ST-T changes (1)
CL Item
J point elevation (2)
CL Item
ST elevation (3)
CL Item
ST-elevation - pericarditis (4)
CL Item
ST depression (5)
CL Item
ST segment abnormality, not specified (6)
CL Item
U waves abnormal (7)
CL Item
T wave inversion (8)
CL Item
T wave peaked (9)
CL Item
T waves flat (10)
CL Item
T waves biphasic (11)
CL Item
Notched T-waves (12)
CL Item
Low QRS voltage (13)
CL Item
T-wave flattening/inversion (14)
CL Item
T wave abnormality, not specified (15)
CL Item
Juvenile T wave pattern, early repolarisation (16)
CL Item
Other depolarisation/repolarisation (17)
Enter Comment
Item
Enter Comment
text
C0947611 (UMLS CUI [1])
Item
Other ECG abnormalities
integer
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
CL Item
Other abnormalities (1)
Specify other ECG abnormalities
Item
Specify other ECG abnormalities
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])