Informações:
Falhas:
ID
32703
Descrição
Study ID: 107038 Clinical Study ID: LPL107038 Study Title: Study to Estimate the Dose Proportionality of the Enteric-Coated Freebase Formulation of SB-480848 Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: Tyrisa ,US Study Indication: Atherosclerosis
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Versões (1)
- 13/11/2018 13/11/2018 -
Titular dos direitos
GSK group of companies
Transferido a
13 novembre 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Estimation of Dose Proportionality of Darapladib - 107038
Follow-Up: 12-lead ECG Abnormalities
- StudyEvent: ODM
Similar models
Follow-Up: 12-lead ECG Abnormalities
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Date of ECG
Item
Date of ECG
date
Time of ECG
Item
Time of ECG
time
Item Group
Record clinically significant abnormalities below.
Check YES for all that apply:
Item
Check YES for all that apply:
text
Sinus bradycardia
Item
Sinus bradycardia
boolean
Sinus bradycardia (heart rate 40-50 bpm)
Item
Sinus bradycardia (heart rate 40-50 bpm)
boolean
Sinus bradycardia (heart rate 30-39 bpm)
Item
Sinus bradycardia (heart rate 30-39 bpm)
boolean
Sinus bradycardia (heart rate <30 bpm)
Item
Sinus bradycardia (heart rate <30 bpm)
boolean
Sinus pause
Item
Sinus pause
boolean
Sinus tachycardia (heart rate >100 bpm)
Item
Sinus tachycardia (heart rate >100 bpm)
boolean
Ectopic supraventricular beats
Item
Ectopic supraventricular beats
boolean
Ectopic supraventricular rhythm
Item
Ectopic supraventricular rhythm
boolean
Wandering atrial pacemaker
Item
Wandering atrial pacemaker
boolean
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 bpm)
Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 bpm)
boolean
Supraventricular tachycardia (heart rate >100 bpm)
Item
Supraventricular tachycardia (heart rate >100 bpm)
boolean
Atrial flutter
Item
Atrial flutter
boolean
Atrial fibrillation
Item
Atrial fibrillation
boolean
Junctional rhythm (heart rate <=100 bpm)
Item
Junctional rhythm (heart rate <=100 bpm)
boolean
Junctional rhythm
Item
Junctional rhythm
boolean
Junctional tachycardia (heart rate > 100 bpm)
Item
Junctional tachycardia (heart rate > 100 bpm)
boolean
Ectopic ventricular beats
Item
Ectopic ventricular beats
boolean
Ventricular couplets
Item
Ventricular couplets
boolean
Bigeminy
Item
Bigeminy
boolean
Trigeminy
Item
Trigeminy
boolean
Electrical alternans
Item
Electrical alternans
boolean
R on T phenomenon
Item
R on T phenomenon
boolean
Ventricular fibrillation
Item
Ventricular fibrillation
boolean
Idioventricular rhythm (heart rate < 100 bpm)
Item
Idioventricular rhythm (heart rate < 100 bpm)
boolean
Sustained ventricular tachycardia
Item
Sustained ventricular tachycardia
boolean
Non-sustained ventricular tachycardia
Item
Non-sustained ventricular tachycardia
boolean
Wide QRS Tachycardia (diagnosis unknown)
Item
Wide QRS Tachycardia (diagnosis unknown)
boolean
Ventricular tachycardia
Item
Ventricular tachycardia
boolean
Monomorphic ventricular tachycardia
Item
Monomorphic ventricular tachycardia
boolean
Torsades de Pointes (Polymosphic ventricular tachycardia with prolonged QT)
Item
Torsades de Pointes (Polymosphic ventricular tachycardia with prolonged QT)
boolean
Polymorphic (sustained and non-sustained) ventricular tachycardia
Item
Polymorphic (sustained and non-sustained) ventricular tachycardia
boolean
Artificial pacemaker
Item
Artificial pacemaker
boolean
Other abnormal rhythm
Item
Other abnormal rhythm
text
Left atrial abnormality (P mitrale)
Item
Left atrial abnormality (P mitrale)
boolean
Rightatrial abnormality (P pulmonale)
Item
Rightatrial abnormality (P pulmonale)
boolean
Right ventricular hypertrophy
Item
Right ventricular hypertrophy
boolean
Intraatrial conduction delay
Item
Intraatrial conduction delay
boolean
Increased voltage consistent with left ventricular hypertrophy
Item
Increased voltage consistent with left ventricular hypertrophy
boolean
Other morphology
Item
Other morphology
text
First degree AV block (PR interval > 200 msec)
Item
First degree AV block (PR interval > 200 msec)
boolean
Short PR interval
Item
Short PR interval
boolean
Second degree AV block (Mobitz type 1)
Item
Second degree AV block (Mobitz type 1)
boolean
Second degree AV block (Mobitz type 2)
Item
Second degree AV block (Mobitz type 2)
boolean
Second degree AV block (Mobitz type 2)
Item
Second degree AV block (Mobitz type 2)
boolean
2:1 AV block
Item
2:1 AV block
boolean
Third degree AV block
Item
Third degree AV block
boolean
Left axis deviation (QRS axis more negative than -30°)
Item
Left axis deviation (QRS axis more negative than -30°)
boolean
Right axis deviation (QRS axis more positive than +110°)
Item
Right axis deviation (QRS axis more positive than +110°)
boolean
Incomplete right bundle branch block
Item
Incomplete right bundle branch block
boolean
Incomplete left bundle branch block
Item
Incomplete left bundle branch block
boolean
Right bundle branch block
Item
Right bundle branch block
boolean
Left anterior hemiblock (synonymous to left anterior fascicular block)
Item
Left anterior hemiblock (synonymous to left anterior fascicular block)
boolean
Left posterior hemiblock (synonymous to left posterior fascicular block)
Item
Left posterior hemiblock (synonymous to left posterior fascicular block)
boolean
Left bundle branch block
Item
Left bundle branch block
boolean
Bifascicular block
Item
Bifascicular block
boolean
Non-specific intraventricular conduction delay (QRS >=120msec)
Item
Non-specific intraventricular conduction delay (QRS >=120msec)
boolean
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
boolean
Prolonged QT interval
Item
Prolonged QT interval
boolean
QT/QTc prolongation >=500 msec
Item
QT/QTc prolongation >=500 msec
boolean
AV dissociation
Item
AV dissociation
boolean
Other conduction
Item
Other conduction
text
Myocardial infraction, old
Item
Myocardial infraction, old
boolean
Myocardial infraction, anterior
Item
Myocardial infraction, anterior
boolean
Myocardial infraction, lateral
Item
Myocardial infraction, lateral
boolean
Myocardial infraction, posterior
Item
Myocardial infraction, posterior
boolean
Myocardial infraction, inferior
Item
Myocardial infraction, inferior
boolean
Myocardial infraction, septal
Item
Myocardial infraction, septal
boolean
Myocardial infraction, Non-Q wave
Item
Myocardial infraction, Non-Q wave
boolean
Other myocardial infraction
Item
Other myocardial infraction
text
Non-specific ST-T changes
Item
Non-specific ST-T changes
boolean
J point elevation
Item
J point elevation
boolean
ST elevation
Item
ST elevation
boolean
ST elevation-pericarditis
Item
ST elevation-pericarditis
boolean
ST depression
Item
ST depression
boolean
U waves abnormal
Item
U waves abnormal
boolean
T wave inversion
Item
T wave inversion
boolean
T wave peaked
Item
T wave peaked
boolean
T waves flat
Item
T waves flat
boolean
T waves biphasic
Item
T waves biphasic
boolean
Notched T-waves
Item
Notched T-waves
boolean
Low QRS voltage
Item
Low QRS voltage
boolean
T-wave flattening/inversion
Item
T-wave flattening/inversion
boolean
Other depolarisation/repolarisation
Item
Other depolarisation/repolarisation
text
Other Abnormalities, enter comment
Item
Other Abnormalities, enter comment
text
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