ID

40993

Descripción

Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

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Versiones (1)
  1. 8/6/20 8/6/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

8 de junio de 2020

DOI

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Licencia

Creative Commons BY-NC 4.0
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Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447

Inglés

Continuous Holter ECG Abnormalities

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Continuous Holter ECG
Descripción

Continuous Holter ECG

Alias
UMLS CUI-1
C0013801
Date of ECG
Descripción

Date of ECG

Tipo de datos

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Descripción

Time of ECG

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
A. Rhythm
Descripción

Record clinically significant abnormalities below. Check all that apply:

Tipo de datos

text

Alias
UMLS CUI [1]
C0232187
A. Rhythm - Comment
Descripción

A. Rhythm - Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0232187
UMLS CUI [1,2]
C0947611
B. P-Wave and QRS Morphology
Descripción

Record clinically significant abnormalities below. Check all that apply:

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2216025
UMLS CUI [1,2]
C0429098
B. P-Wave and QRS Morphology - Comment
Descripción

B. P-Wave and QRS Morphology - Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2216025
UMLS CUI [1,2]
C0429098
UMLS CUI [1,3]
C0947611
C. Conduction
Descripción

Record clinically significant abnormalities below. Check all that apply:

Tipo de datos

text

Alias
UMLS CUI [1]
C0232217
C. Conduction Comment
Descripción

C. Conduction Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0232217
UMLS CUI [1,2]
C0947611
D. Myocardial Infarction
Descripción

Record clinically significant abnormalities below. Check all that apply:

Tipo de datos

text

Alias
UMLS CUI [1]
C0027051
D. Myocardial Infarction - Comment
Descripción

D. Myocardial Infarction - Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0947611
E. Depolarisation/Repolarisation (QRS-T)
Descripción

Record clinically significant abnormalities below. Check all that apply:

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1331539
UMLS CUI [1,2]
C0948857
E. Depolarisation/Repolarisation (QRS-T) - Comment
Descripción

E. Depolarisation/Repolarisation (QRS-T) - Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1331539
UMLS CUI [1,2]
C0948857
UMLS CUI [1,3]
C0947611
Other Abnormalities
Descripción

Other Abnormalities

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
Other Abnormalities - Comment
Descripción

Other Abnormalities - Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
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Similar models

Continuous Holter ECG Abnormalities

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Continuous Holter ECG
C0013801 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
A. Rhythm
text
C0232187 (UMLS CUI [1])
A. Rhythm
Code List
A. Rhythm
CL Item
Sinus bradycardia (A1)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (A21)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (A22)
CL Item
Sinus bradycardia (heart rate < 30 beats/min) (A23)
CL Item
Sinus pause (A3)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (A2)
CL Item
Ectopic supraventricular beats (A4)
CL Item
Ectopic supraventricular rhythm (A20)
CL Item
Wandering atrial pacemaker (A17)
CL Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (A26)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (A6)
CL Item
Atrial flutter (A7)
CL Item
Atrial fibrillation (A8)
CL Item
Junctional rhythm (heart rate ≤100 beats/min) (A5)
CL Item
Junctional rhythm (A25)
CL Item
Junctional tachycardia (heart rate > 100 beats/min) (A24)
CL Item
Ectopic ventricular beats (A9)
CL Item
Ventricular couplets (A12)
CL Item
Bigeminy (A13)
CL Item
Trigeminy (A28)
CL Item
Electrical alternans (A14)
CL Item
R on T phenomenon (A29)
CL Item
Ventricular fibrillation (A18)
CL Item
Idioventricular rhythm (heart rate < 100 beats/min) (A19)
CL Item
Sustained ventricular tachycardia (A10)
CL Item
Non-sustained ventricular tachycardia (A11)
CL Item
Wide QRS Tachycardia (diagnosis unknown) (A32)
CL Item
Ventricular tachycardia (A27)
CL Item
Monomorphic ventricular tachycardia (A30)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (A15)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (A31)
CL Item
Artificial pacemaker (A16)
CL Item
Other abnormal rhythm (A99)
A. Rhythm - Comment
Item
A. Rhythm - Comment
text
C0232187 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
B. P-Wave and QRS Morphology
text
C2216025 (UMLS CUI [1,1])
C0429098 (UMLS CUI [1,2])
B. P-Wave and QRS Morphology
Code List
B. P-Wave and QRS Morphology
CL Item
Left atrial abnormality (P mitrale) (B1)
CL Item
Right atrial abnormality (P pulmonale) (B2)
CL Item
Right ventricular hypertrophy (B3)
CL Item
Intraatrial conduction delay (B5)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
CL Item
Other morphology (B99)
B. P-Wave and QRS Morphology - Comment
Item
B. P-Wave and QRS Morphology - Comment
text
C2216025 (UMLS CUI [1,1])
C0429098 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
C. Conduction
text
C0232217 (UMLS CUI [1])
C. Conduction
Code List
C. Conduction
CL Item
First degree AV block (PR interval > 200 msec) (C1)
CL Item
Short PR interval (C20)
CL Item
Second degree AV block (Mobitz type 1) (C2)
CL Item
Second degree AV block (Mobitz type 2) (C3)
CL Item
2:1 AV block (C16)
CL Item
Third degree AV block (C4)
CL Item
Left axis deviation (QRS axis more negative than -30°) (C5)
CL Item
Right axis deviation (QRS axis more positive than +110°) (C6)
CL Item
Incomplete right bundle branch block (C7)
CL Item
Incomplete left bundle branch block (C13)
CL Item
Right bundle branch block (C8)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (C14)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
CL Item
Left bundle branch block (C9)
CL Item
Bifascicular block (C17)
CL Item
Non-specific intraventricular conduction delay (QRS ≥ 120 msec) (C10)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
CL Item
Prolonged QT interval (C19)
CL Item
QT/QTc prolongation ≥ 500 msec (C12)
CL Item
AV dissociation (C18)
CL Item
Other conduction (C99)
C. Conduction Comment
Item
C. Conduction Comment
text
C0232217 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
D. Myocardial Infarction
text
C0027051 (UMLS CUI [1])
D. Myocardial Infarction
Code List
D. Myocardial Infarction
CL Item
Myocardial infarction, old (D1)
CL Item
Myocardial infarction, anterior (D2)
CL Item
Myocardial infarction, lateral (D3)
CL Item
Myocardial infarction, posterior (D4)
CL Item
Myocardial infarction, inferior (D5)
CL Item
Myocardial infarction, septal (D6)
CL Item
Myocardial infarction, Non-Q wave (D20)
CL Item
Other myocardial infarction (D98)
D. Myocardial Infarction - Comment
Item
D. Myocardial Infarction - Comment
text
C0027051 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
E. Depolarisation/Repolarisation (QRS-T)
text
C1331539 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
E. Depolarisation/Repolarisation (QRS-T)
Code List
E. Depolarisation/Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes (D7)
CL Item
J point elevation (D19)
CL Item
ST elevation (D8)
CL Item
ST elevation-pericarditis (D21)
CL Item
ST depression (D9)
CL Item
U waves abnormal (D10)
CL Item
T wave inversion (D11)
CL Item
T wave peaked (D12)
CL Item
T waves flat (D15)
CL Item
T waves biphasic (D16)
CL Item
Notched T-waves (D18)
CL Item
Low QRS voltage (D13)
CL Item
T-wave flattening/inversion (D17)
CL Item
Other depolarisation/repolarisation (D99)
E. Depolarisation/Repolarisation (QRS-T) - Comment
Item
E. Depolarisation/Repolarisation (QRS-T) - Comment
text
C1331539 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
Other Abnormalities
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other Abnormalities
Code List
Other Abnormalities
CL Item
Other abnormalities (E99)
Other Abnormalities - Comment
Item
Other Abnormalities - Comment
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
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