ID

34031

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

Keywords

Versions (2)
  1. 11/9/18 11/9/18 -
  2. 1/11/19 1/11/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 11, 2019

DOI

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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

English

Logs and Repeats: 12-lead ECG Abnormalities

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Description

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Description

Patient Number

Data type

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
12-lead ECG Abnormalities
Description

12-lead ECG Abnormalities

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
Date of ECG
Description

Date of ECG

Data type

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Record clinically significant abnormalities below. Check all that apply:
Description

Record clinically significant abnormalities below. Check all that apply:

Alias
UMLS CUI-1
C0522055
UMLS CUI-2
C2826293
A. Rhythm
Description

A. Rhythm

Data type

text

Alias
UMLS CUI [1]
C0871269
If Other, enter comment
Description

If Other, enter comment

Data type

text

Alias
UMLS CUI [1]
C0205394
UMLS CUI [2]
C0947611
B. P-Wave Morphology
Description

B. P-Wave Morphology

Data type

text

Alias
UMLS CUI [1]
C2216025
If Other, enter comment
Description

If Other, enter comment

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0947611
C. Conduction
Description

C. Conduction

Data type

text

Alias
UMLS CUI [1]
C0232217
If Other, enter comment
Description

If Other, enter comment

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0947611
D. Myocardial Infraction
Description

D. Myocardial Infraction

Data type

text

Alias
UMLS CUI [1]
C0027051
If Other, enter comment
Description

If Other, enter comment

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0947611
E. Depolarisation/Repolarisation (QRS-T)
Description

E. Depolarisation/Repolarisation (QRS-T)

Data type

text

Alias
UMLS CUI [1]
C1331539
UMLS CUI [2]
C0948857
If Other, enter comment
Description

If Other, enter comment

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0947611
Other Abnormalities, enter comment
Description

Other Abnormalities, enter comment

Data type

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0947611
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Similar models

Logs and Repeats: 12-lead ECG Abnormalities

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
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])
Item Group
12-lead ECG Abnormalities
C0430456 (UMLS CUI-1)
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])
Item Group
Record clinically significant abnormalities below. Check all that apply:
C0522055 (UMLS CUI-1)
C2826293 (UMLS CUI-2)
Item
A. Rhythm
text
C0871269 (UMLS CUI [1])
A. Rhythm
Code List
A. Rhythm
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])
Item
B. P-Wave Morphology
text
C2216025 (UMLS CUI [1])
B. P-Wave Morphology
Code List
B. P-Wave Morphology
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])
Item
C. Conduction
text
C0232217 (UMLS CUI [1])
C. Conduction
Code List
C. Conduction
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])
Item
D. Myocardial Infraction
text
C0027051 (UMLS CUI [1])
D. Myocardial Infraction
Code List
D. Myocardial Infraction
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])
Item
E. Depolarisation/Repolarisation (QRS-T)
text
C1331539 (UMLS CUI [1])
C0948857 (UMLS CUI [2])
E. Depolarisation/Repolarisation (QRS-T)
Code List
E. Depolarisation/Repolarisation (QRS-T)
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])
Other Abnormalities, enter comment
Item
Other Abnormalities, enter comment
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
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