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Fel:
ID
39241
Beskrivning
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
Nyckelord
Versioner (3)
- 2019-12-11 2019-12-11 -
- 2019-12-16 2019-12-16 -
- 2020-01-09 2020-01-09 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
11 december 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease
Follow-up - ECG; Study Conclusion
- StudyEvent: ODM
Similar models
Follow-up - ECG; Study Conclusion
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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])
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Adverse Event (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol defined (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to follow-up (6)
CL Item
Investigator discretion (7)
CL Item
Withdrew consent (8)
Was follow-up contact attempted three times?
Item
Was follow-up contact attempted three times?
boolean
C1522577 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0332158 (UMLS CUI [1,2])
Was a follow-up letter mailed?
Item
Was a follow-up letter mailed?
boolean
C1522577 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,3])
C1096774 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,3])
Specify follow-up letter
Item
Specify follow-up letter
text
C1522577 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1096774 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
C2347038 (UMLS CUI-2)
Was the treatment blind broken during the study?
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date/time blind broken
Item
Date/time blind broken
datetime
C3897431 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Medical emergency (1)
CL Item
Other (2)
Other reason blind broken
Item
Other reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])