ID

30529

Descripción

Study part: 12- Lead ECG Abnormalities (ECG Abn). A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Palabras clave

Versiones (1)
  1. 11/6/18 11/6/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

11 de junio de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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12- Lead ECG Abnormalities (ECG Abn) Pazopanib Macular Degeneration MD1103367

Inglés

12- Lead ECG Abnormalities (ECG Abn)

1 formularios  
12-LEAD ECG ABNORMALITIES
Descripción

12-LEAD ECG ABNORMALITIES

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
1. Date and Time of ECG
Descripción

Date and Time ECG

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826846
2. Record clinically significant abnormalities- A. Rhythm
Descripción

12 Lead ECG abnormalities Rhythm

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0199556
Other abnormal rhythm, enter comment
Descripción

other rhythm abnormal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0199556
UMLS CUI [1,3]
C0205161
2. Record clinically significant abnormalities- B. P-Wave Morphology
Descripción

12 Lead ECG abnormalities Morphology

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0332437
Other morphology, enter comment
Descripción

Other morphology

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0522055
UMLS CUI [1,3]
C0332437
2. Record clinically significant abnormalities- C. Conduction
Descripción

12 Lead ECG abnormalities Cardiac conduction

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0232217
Other conduction, enter comment
Descripción

Other conduction

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0232217
UMLS CUI [1,3]
C0522055
2. Record clinically significant abnormalities- D. Myocardial Infarction
Descripción

12 Lead ECG abnormalities Myocardial Infarction

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0027051
Other myocardial infarction, enter comment
Descripción

Other myocardial infarction

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0027051
2. Record clinically significant abnormalities- E. Depolarisation/Repolarisation (QRS-T)
Descripción

12 Lead ECG abnormalities

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
Other depolarisation/repolarisation, enter comment
Descripción

Other repolarisation

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0948857
2. Record clinically significant abnormalities- Other abnormalities, enter comment
Descripción

E99

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
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Similar models

12- Lead ECG Abnormalities (ECG Abn)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
12-LEAD ECG ABNORMALITIES
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Date and Time ECG
Item
1. Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Item
2. Record clinically significant abnormalities- A. Rhythm
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
undefined item
Code List
2. Record clinically significant abnormalities- A. Rhythm
CL Item
Sinus bradycardia  (A1)
C0085610 (UMLS CUI-1)
(Comment:en)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min)  (A21)
C0085610 (UMLS CUI-1)
(Comment:en)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (A22)
C0085610 (UMLS CUI-1)
(Comment:en)
CL Item
Sinus bradycardia (heart rate <30 beats/min)  (A23)
C0085610 (UMLS CUI-1)
(Comment:en)
CL Item
Sinus pause  (A3)
C0541782 (UMLS CUI-1)
(Comment:en)
CL Item
Sinus tachycardia (heart rate> 100 beats/min)  (A2)
C0039239 (UMLS CUI-1)
(Comment:en)
CL Item
Ectopic supraventricular beats (A4)
C0033036 (UMLS CUI-1)
(Comment:en)
CL Item
Ectopic supraventricular rhythm (A20)
C2348376 (UMLS CUI-1)
(Comment:en)
CL Item
Wandering atrial pacemaker (A17)
C1321523 (UMLS CUI-1)
(Comment:en)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate > I 00 beats/min)  (A26)
C0221158 (UMLS CUI-1)
(Comment:en)
CL Item
Supra ventricular tachycardia (heart rate> I 00 beat/min)  (A6)
C0039240 (UMLS CUI-1)
(Comment:en)
CL Item
Atrial flutter (A7)
C0004239 (UMLS CUI-1)
(Comment:en)
CL Item
Atrial fibrillation  (A8)
C0004238 (UMLS CUI-1)
(Comment:en)
CL Item
Junctional rhythm (heart rate<= 100 beat /min)  (A5)
C0232208 (UMLS CUI-1)
(Comment:en)
CL Item
Junctional rhythm  (A25)
C0232208 (UMLS CUI-1)
(Comment:en)
CL Item
Junctional tachycardia (heart rate> I 00 beats/min)  (A24)
C0039235 (UMLS CUI-1)
(Comment:en)
CL Item
Ectopic ventricular beats  (A9)
C0151636 (UMLS CUI-1)
(Comment:en)
CL Item
Ventricular couplets (A12)
C0429001 (UMLS CUI-1)
(Comment:en)
CL Item
Bigeminy  (A13)
C0262662 (UMLS CUI-1)
(Comment:en)
CL Item
Trigeminy  (A28)
C0428999 (UMLS CUI-1)
(Comment:en)
CL Item
Electrical alternans (A14)
C1142551 (UMLS CUI-1)
(Comment:en)
CL Item
R on T phenomenon  (A29)
C0877658 (UMLS CUI-1)
(Comment:en)
CL Item
Ventricular fibrillation  (A18)
C0042510 (UMLS CUI-1)
(Comment:en)
CL Item
ldioventricular rhythm  (A19)
C0700363 (UMLS CUI-1)
(Comment:en)
CL Item
Sustained ventricular tachycardia (A10)
C0750197 (UMLS CUI-1)
(Comment:en)
CL Item
Non-sustained ventricular tachycardia  (A11)
C0750194 (UMLS CUI-1)
(Comment:en)
CL Item
Ventricular tachycardia  (A27)
C0042514 (UMLS CUI-1)
(Comment:en)
CL Item
Monomorphic ventricular tachycardia  (A30)
C0344431 (UMLS CUI-1)
(Comment:en)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)  (A15)
C0040479 (UMLS CUI-1)
(Comment:en)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia  (A31)
C0344432 (UMLS CUI-1)
(Comment:en)
CL Item
Artificial Pacemaker (A16)
C0030163 (UMLS CUI-1)
(Comment:en)
CL Item
Other abnormal rhvthm (A99)
C0205394 (UMLS CUI-1)
C0199556 (UMLS CUI-2)
C0205161 (UMLS CUI-3)
(Comment:en)
other rhythm abnormal
Item
Other abnormal rhythm, enter comment
text
C0205394 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Item
2. Record clinically significant abnormalities- B. P-Wave Morphology
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,3])
undefined item
Code List
2. Record clinically significant abnormalities- B. P-Wave Morphology
CL Item
Left atrial abnormality (P mitrale) (B1)
C0344711 (UMLS CUI-1)
C0232310 (UMLS CUI-2)
(Comment:en)
CL Item
Right atrial abnormality (P pulmonale) (B2)
C0344696 (UMLS CUI-1)
C0232308 (UMLS CUI-2)
(Comment:en)
CL Item
Right ventricular hypertrophy (B3)
C0162770 (UMLS CUI-1)
(Comment:en)
CL Item
Intraatrial conduction delay (B5)
C2346510 (UMLS CUI-1)
(Comment:en)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
C1112650 (UMLS CUI-1)
(Comment:en)
CL Item
other morphology (B99)
C0205394 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
C0332437 (UMLS CUI-3)
(Comment:en)
Other morphology
Item
Other morphology, enter comment
text
C0205394 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,3])
Item
2. Record clinically significant abnormalities- C. Conduction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
undefined item
Code List
2. Record clinically significant abnormalities- C. Conduction
CL Item
First degree AV block (PR interval> 200msec)  (C1)
C0085614 (UMLS CUI-1)
(Comment:en)
CL Item
Second degree AV block (Mobitz type 1)  (C2)
C0264907 (UMLS CUI-1)
(Comment:en)
CL Item
Second degree AV block (Mobitz type 2)  (C3)
C0155700 (UMLS CUI-1)
(Comment:en)
CL Item
2: 1 AV block  (C16)
C2346542 (UMLS CUI-1)
(Comment:en)
CL Item
Third degree AV block  (C4)
C0151517 (UMLS CUI-1)
(Comment:en)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees)  (C5)
C0232297 (UMLS CUI-1)
(Comment:en)
CL Item
Right axis deviation (QRS axis more positive than+ 110 degrees)  (C6)
C0232296 (UMLS CUI-1)
(Comment:en)
CL Item
Incomplete right bundle branch block  (C7)
C0262525 (UMLS CUI-1)
(Comment:en)
CL Item
Incomplete left bundle branch block  (C13)
C0281878 (UMLS CUI-1)
(Comment:en)
CL Item
Right bundle branch block (C8)
C0085615 (UMLS CUI-1)
(Comment:en)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block)  (C14)
C0264912 (UMLS CUI-1)
(Comment:en)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block)  (C15)
C0264913 (UMLS CUI-1)
(Comment:en)
CL Item
Left bundle branch block (C9)
C0023211 (UMLS CUI-1)
(Comment:en)
CL Item
Bifascicular block  (C17)
C0264914 (UMLS CUI-1)
(Comment:en)
CL Item
Non-specific intraventricular conduction delay (QRS >= 120 msec)  (C10)
C3697597 (UMLS CUI-1)
(Comment:en)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
C0264897 (UMLS CUI-1)
C0043202 (UMLS CUI-2)
(Comment:en)
CL Item
QT/QTc prolongation >=500msec (C12)
C0855333 (UMLS CUI-1)
(Comment:en)
CL Item
AV dissociation (C18)
C0004331 (UMLS CUI-1)
(Comment:en)
CL Item
Other conduction (C99)
C0205394 (UMLS CUI-1)
C0232217 (UMLS CUI-2)
C0522055 (UMLS CUI-3)
(Comment:en)
Other conduction
Item
Other conduction, enter comment
text
C0205394 (UMLS CUI [1,1])
C0232217 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,3])
Item
2. Record clinically significant abnormalities- D. Myocardial Infarction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
undefined item
Code List
2. Record clinically significant abnormalities- D. Myocardial Infarction
CL Item
Myocardial infarction, old  (D1)
C0155668 (UMLS CUI-1)
(Comment:en)
CL Item
Myocardial infarction, anterior  (D2)
C0340293 (UMLS CUI-1)
(Comment:en)
CL Item
Myocardial infarction, lateral  (D3)
C0340312 (UMLS CUI-1)
(Comment:en)
CL Item
Myocardial infarction, posterior  (D4)
C0340319 (UMLS CUI-1)
(Comment:en)
CL Item
Myocardial infarction, inferior  (D5)
C0340305 (UMLS CUI-1)
(Comment:en)
CL Item
Myocardial infarction, septal  (D6)
C0746727 (UMLS CUI-1)
(Comment:en)
CL Item
Myocardial infarction, Non Q-wave  (D20)
C0542269 (UMLS CUI-1)
(Comment:en)
CL Item
Other myocardial infarction (D98)
C0205394 (UMLS CUI-1)
C0027051 (UMLS CUI-2)
(Comment:en)
Other myocardial infarction
Item
Other myocardial infarction, enter comment
text
C0205394 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
Item
2. Record clinically significant abnormalities- E. Depolarisation/Repolarisation (QRS-T)
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
undefined item
Code List
2. Record clinically significant abnormalities- E. Depolarisation/Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes  (D7)
C1112720 (UMLS CUI-1)
(Comment:en)
CL Item
J point elevation  (D19)
C2346597 (UMLS CUI-1)
(Comment:en)
CL Item
ST elevation  (D8)
C0520886 (UMLS CUI-1)
(Comment:en)
CL Item
ST-elevation - pericarditis  (D21)
C2348119 (UMLS CUI-1)
(Comment:en)
CL Item
ST depression  (D9)
C0520887 (UMLS CUI-1)
(Comment:en)
CL Item
U waves abnormal (D10)
C0438169 (UMLS CUI-1)
(Comment:en)
CL Item
T wave inversion  (D11)
C0520888 (UMLS CUI-1)
(Comment:en)
CL Item
T wave peaked  (D12)
C0239242 (UMLS CUI-1)
(Comment:en)
CL Item
T waves flat  (D15)
C2215959 (UMLS CUI-1)
(Comment:en)
CL Item
T waves biphasic  (D16)
C2348639 (UMLS CUI-1)
(Comment:en)
CL Item
Notched T-waves  (D18)
C2347367 (UMLS CUI-1)
(Comment:en)
CL Item
Low QRS voltage  (D13)
C2349945 (UMLS CUI-1)
(Comment:en)
CL Item
T-wave flattening/inversion  (D17)
C0520888 (UMLS CUI-1)
C0429059 (UMLS CUI-2)
(Comment:en)
CL Item
Other depolarisation/repolarisation (D99)
C0205394 (UMLS CUI-1)
C0948857 (UMLS CUI-2)
(Comment:en)
Other repolarisation
Item
Other depolarisation/repolarisation, enter comment
text
C0205394 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
other 12 Lead ECG abnormalities
Item
2. Record clinically significant abnormalities- Other abnormalities, enter comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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