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ID
32640
Description
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension
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Versions (2)
- 11/9/18 11/9/18 -
- 1/11/19 1/11/19 -
Copyright Holder
GSK group of companies
Uploaded on
November 9, 2018
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License
Creative Commons BY-NC 3.0
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A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904
Logs and Repeats: 12-lead ECG Abnormalities
- StudyEvent: ODM
Similar models
Logs and Repeats: 12-lead ECG Abnormalities
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Site
Item
Site
text
Patient
Item
Patient
text
Patient Number
Item
Patient Number
integer
Date of ECG
Item
Date of ECG
date
Time of ECG
Item
Time of ECG
time
Item Group
Record clinically significant abnormalities below. Check all that apply:
CL Item
Sinus bradycardia (1)
CL Item
Sinus bradycardia (heart rate 40-50 bpm) (2)
CL Item
Sinus bradycardia (heart rate 30-39 bpm) (3)
CL Item
Sinus bradycardia (heart rate <30 bpm) (4)
CL Item
Sinus pause (5)
CL Item
Sinus tachycardia (heart rate >100 bpm) (6)
CL Item
Ectopic supraventricular beats (7)
CL Item
Ectopic supraventricular rhythm (8)
CL Item
[A17] Wandering atrial pacemaker (9)
CL Item
[A26] Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 bpm) (10)
CL Item
Supraventricular tachycardia (heart rate >100 bpm) (11)
CL Item
Atrial flutter (12)
CL Item
Atrial fibrillation (13)
CL Item
Junctional rhythm (heart rate <=100 bpm) (14)
CL Item
Junctional rhythm (15)
CL Item
[A24] Junctional tachycardia (heart rate > 100 bpm) (16)
CL Item
Ectopic ventricular beats (17)
CL Item
Ventricular couplets (18)
CL Item
Bigeminy (19)
CL Item
Trigeminy (20)
CL Item
Electrical alternans (21)
CL Item
R on T phenomenon (22)
CL Item
Ventricular fibrillation (23)
CL Item
[A19] Idioventricular rhythm (heart rate < 100 bpm) (24)
CL Item
Sustained ventricular tachycardia (25)
CL Item
Non-sustained ventricular tachycardia (26)
CL Item
Wide QRS Tachycardia (diagnosis unknown) (27)
CL Item
Ventricular tachycardia (28)
CL Item
Monomorphic ventricular tachycardia (29)
CL Item
Torsades de Pointes (Polymosphic ventricular tachycardia with prolonged QT) (30)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (31)
CL Item
Artificial pacemaker (32)
CL Item
Other abnormal rhythm (33)
If Other, enter comment
Item
If Other, enter comment
text
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Rightatrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy (3)
CL Item
Intraatrial conduction delay (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology (6)
If Other, enter comment
Item
If Other, enter comment
text
CL Item
First degree AV block (PR interval > 200 msec) (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°) (7)
CL Item
Right axis deviation (QRS axis more positive than +110°) (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 >=120msec) (16)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (17)
CL Item
Prolonged QT interval (18)
CL Item
QT/QTc prolongation >=500 msec (19)
CL Item
AV dissociation (20)
CL Item
Other conduction (21)
If Other, enter comment
Item
If Other, enter comment
text
CL Item
Myocardial infraction, old (1)
CL Item
Myocardial infraction, anterior (2)
CL Item
Myocardial infraction, lateral (3)
CL Item
Myocardial infraction, posterior (4)
CL Item
Myocardial infraction, inferior (5)
CL Item
Myocardial infraction, septal (6)
CL Item
Myocardial infraction, Non-Q wave (7)
CL Item
Other myocardial infraction (8)
If Other, enter comment
Item
If Other, enter comment
text
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
U waves abnormal (6)
CL Item
T wave inversion (7)
CL Item
T wave peaked (8)
CL Item
T waves flat (9)
CL Item
T waves biphasic (10)
CL Item
Notched T-waves (11)
CL Item
Low QRS voltage (12)
CL Item
T-wave flattening/inversion (13)
CL Item
Other depolarisation/repolarisation (14)
If Other, enter comment
Item
If Other, enter comment
text
Other Abnormalities, enter comment
Item
Other Abnormalities, enter comment
text