ID

36213

Beschreibung

Study ID: 101963 Clinical Study ID: SCA101963 Study Title: A randomised, blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and risperidone in healthy, non-smoking, male volunteers. 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: lamotrigine Trade Name: Lamictal XR,Lamictal,LAMICTIN Study Indication: Schizophrenia

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  1. 22.04.19 22.04.19 -
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GlaxoSmithKline

Hochgeladen am

22. April 2019

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Potential Pharmacokinetic Interaction between Lamotrigine and Risperidone; 101963

Englisch

12-Lead ECG Abnormalities

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
12-Lead ECG Abnormalities
Beschreibung

12-Lead ECG Abnormalities

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

12 lead ECG, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Time of ECG
Beschreibung

12 lead ECG, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0040223
Rhythm
Beschreibung

12 lead ECG, Abnormality, Rhythm

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0199556
P-Wave and QRS Morphology
Beschreibung

12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Electrocardiogram QRS complex

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2216025
UMLS CUI [1,4]
C0429098
Conduction
Beschreibung

12 lead ECG, Abnormality, Cardiac conduction

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0232217
Myocardial Infarction
Beschreibung

12 lead ECG, Abnormality, Myocardial Infarction

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0027051
Depolarisation/Repolarisation (QRS-T)
Beschreibung

12 lead ECG, Abnormality, Ventricular Depolarization [PE], Electrocardiogram repolarisation abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C1331539
UMLS CUI [1,4]
C0948857
Other Abnormalities
Beschreibung

12 lead ECG, Abnormality, Other

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
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Ähnliche Modelle

12-Lead ECG Abnormalities

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
12 lead ECG, Date in time
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
12 lead ECG, Time
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Rhythm
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
12 lead ECG, Abnormality, Rhythm
Code List
Rhythm
CL Item
Sinus bradycardia (1)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min)  (2)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min)  (3)
CL Item
Sinus bradycardia (heart rate< 30 beats/min) (4)
CL Item
Sinus pause (5)
CL Item
Sinus tachycardia (heart rate >100 beats/min)  (6)
CL Item
Ectopic supraventricular beats (7)
CL Item
Ectopic supraventricular rhythm (8)
CL Item
Wandering atrial pacemaker (9)
CL Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (10)
CL Item
Supraventricular tachycardia (heart rate > 100 beats/min) (11)
CL Item
Atrial flutter  (12)
CL Item
Atrial fibrillation (13)
CL Item
Junctional rhythm (heart rate ~100 beats/min) (14)
CL Item
Junctional rhythm  (15)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (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
ldioventricular rhythm (heart rate< 100 beats/min) (24)
CL Item
Sustained ventricular tachycardia (25)
CL Item
Non-sustained ventricular tachycardia (26)
CL Item
Ventricular tachycardia (27)
CL Item
Mononnorphic ventricular tachycardia (28)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (29)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (30)
CL Item
Artificial pacemaker  (31)
CL Item
Other abnormal rhythm (32)
Item
P-Wave and QRS Morphology
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2216025 (UMLS CUI [1,3])
C0429098 (UMLS CUI [1,4])
12 lead ECG, Abnormality, electrocardiogram: P wave shifting morphology, Electrocardiogram QRS complex
Code List
P-Wave and QRS Morphology
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy  (3)
CL Item
lnlraatrial conduction delay (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology (6)
Item
Conduction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
12 lead ECG, Abnormality, Cardiac conduction
Code List
Conduction
CL Item
First degree AV block (PR interval> 200 msec)  (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
2:1 AV block (4)
CL Item
Third degree AV block (5)
CL Item
Left axis deviation (QRS axis more negative than -30°) (6)
CL Item
Right axis deviation (QRS axis more positive than +110°) (7)
CL Item
Incomplete right bundle branch block (8)
CL Item
Incomplete left bundle branch blo (9)
CL Item
Right bundle branch block (10)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (11)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (12)
CL Item
Left bundle branch block (13)
CL Item
Bifascicular block (14)
CL Item
Non-specific intraventricular conduction delay (QRS 120 msec) (15)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (16)
CL Item
QT/QTc prolongation >= 500 msec  (17)
CL Item
AV dissociation (18)
CL Item
Other conduction (19)
Item
Myocardial Infarction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
12 lead ECG, Abnormality, Myocardial Infarction
Code List
Myocardial Infarction
CL Item
Myocardial infarction, old  (1)
CL Item
Myocardial infarction, anterior  (2)
CL Item
Myocardial infarction, lateral  (3)
CL Item
Myocardial infarction, posterior  (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal  (6)
CL Item
Myocardial infarction, Non-Q wave  (7)
CL Item
Other myocardial infarction (8)
Item
Depolarisation/Repolarisation (QRS-T)
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,4])
12 lead ECG, Abnormality, Ventricular Depolarization [PE], Electrocardiogram repolarisation abnormality
Code List
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)
12 lead ECG, Abnormality, Other
Item
Other Abnormalities
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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