Informações:
Falhas:
ID
34031
Descrição
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
Palavras-chave
Versões (2)
- 09/11/2018 09/11/2018 -
- 11/01/2019 11/01/2019 -
Titular dos direitos
GSK group of companies
Transferido a
11 de janeiro de 2019
DOI
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Licença
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
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,2])
Item Group
12-lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
Item Group
Record clinically significant abnormalities below. Check all that apply:
C0522055 (UMLS CUI-1)
C2826293 (UMLS CUI-2)
C2826293 (UMLS CUI-2)
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
C0205394 (UMLS CUI [1])
C0947611 (UMLS CUI [2])
C0947611 (UMLS CUI [2])
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
C0205394 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
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
C0205394 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
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
C0205394 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Item
E. Depolarisation/Repolarisation (QRS-T)
text
C1331539 (UMLS CUI [1])
C0948857 (UMLS CUI [2])
C0948857 (UMLS CUI [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
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
C0205394 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Other Abnormalities, enter comment
Item
Other Abnormalities, enter comment
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])