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ID

32703

Description

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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Versions (1)
  1. 11/13/18 11/13/18 -
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GSK group of companies

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November 13, 2018

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    Estimation of Dose Proportionality of Darapladib - 107038

    English

    Follow-Up: 12-lead ECG Abnormalities

    1 forms  
    Administrative data
    Description

    Administrative data

    Date of ECG
    Description

    Date of ECG

    Data type

    date

    Time of ECG
    Description

    Time of ECG

    Data type

    time

    Record clinically significant abnormalities below.
    Description

    Record clinically significant abnormalities below.

    Check YES for all that apply:
    Description

    Check YES for all that apply:

    Data type

    text

    A. Rhythm
    Description

    A. Rhythm

    Sinus bradycardia
    Description

    Sinus bradycardia

    Data type

    boolean

    Sinus bradycardia (heart rate 40-50 bpm)
    Description

    Sinus bradycardia (heart rate 40-50 bpm)

    Data type

    boolean

    Sinus bradycardia (heart rate 30-39 bpm)
    Description

    Sinus bradycardia (heart rate 30-39 bpm)

    Data type

    boolean

    Sinus bradycardia (heart rate <30 bpm)
    Description

    Sinus bradycardia (heart rate <30 bpm)

    Data type

    boolean

    Sinus pause
    Description

    Sinus pause

    Data type

    boolean

    Sinus tachycardia (heart rate >100 bpm)
    Description

    Sinus tachycardia (heart rate >100 bpm)

    Data type

    boolean

    Ectopic supraventricular beats
    Description

    Ectopic supraventricular beats

    Data type

    boolean

    Ectopic supraventricular rhythm
    Description

    Ectopic supraventricular rhythm

    Data type

    boolean

    Wandering atrial pacemaker
    Description

    Wandering atrial pacemaker

    Data type

    boolean

    Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 bpm)
    Description

    Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 bpm)

    Data type

    boolean

    Supraventricular tachycardia (heart rate >100 bpm)
    Description

    Supraventricular tachycardia (heart rate >100 bpm)

    Data type

    boolean

    Atrial flutter
    Description

    Atrial flutter

    Data type

    boolean

    Atrial fibrillation
    Description

    Atrial fibrillation

    Data type

    boolean

    Junctional rhythm (heart rate <=100 bpm)
    Description

    Junctional rhythm (heart rate <=100 bpm)

    Data type

    boolean

    Junctional rhythm
    Description

    Junctional rhythm

    Data type

    boolean

    Junctional tachycardia (heart rate > 100 bpm)
    Description

    Junctional tachycardia (heart rate > 100 bpm)

    Data type

    boolean

    Ectopic ventricular beats
    Description

    Ectopic ventricular beats

    Data type

    boolean

    Ventricular couplets
    Description

    Ventricular couplets

    Data type

    boolean

    Bigeminy
    Description

    Bigeminy

    Data type

    boolean

    Trigeminy
    Description

    Trigeminy

    Data type

    boolean

    Electrical alternans
    Description

    Electrical alternans

    Data type

    boolean

    R on T phenomenon
    Description

    R on T phenomenon

    Data type

    boolean

    Ventricular fibrillation
    Description

    Ventricular fibrillation

    Data type

    boolean

    Idioventricular rhythm (heart rate < 100 bpm)
    Description

    Idioventricular rhythm (heart rate < 100 bpm)

    Data type

    boolean

    Sustained ventricular tachycardia
    Description

    Sustained ventricular tachycardia

    Data type

    boolean

    Non-sustained ventricular tachycardia
    Description

    Non-sustained ventricular tachycardia

    Data type

    boolean

    Wide QRS Tachycardia (diagnosis unknown)
    Description

    Wide QRS Tachycardia (diagnosis unknown)

    Data type

    boolean

    Ventricular tachycardia
    Description

    Ventricular tachycardia

    Data type

    boolean

    Monomorphic ventricular tachycardia
    Description

    Monomorphic ventricular tachycardia

    Data type

    boolean

    Torsades de Pointes (Polymosphic ventricular tachycardia with prolonged QT)
    Description

    Torsades de Pointes (Polymosphic ventricular tachycardia with prolonged QT)

    Data type

    boolean

    Polymorphic (sustained and non-sustained) ventricular tachycardia
    Description

    Polymorphic (sustained and non-sustained) ventricular tachycardia

    Data type

    boolean

    Artificial pacemaker
    Description

    Artificial pacemaker

    Data type

    boolean

    Other abnormal rhythm
    Description

    add comment

    Data type

    text

    B. P-Wave Morphology
    Description

    B. P-Wave Morphology

    Left atrial abnormality (P mitrale)
    Description

    Left atrial abnormality (P mitrale)

    Data type

    boolean

    Rightatrial abnormality (P pulmonale)
    Description

    Rightatrial abnormality (P pulmonale)

    Data type

    boolean

    Right ventricular hypertrophy
    Description

    Right ventricular hypertrophy

    Data type

    boolean

    Intraatrial conduction delay
    Description

    Intraatrial conduction delay

    Data type

    boolean

    Increased voltage consistent with left ventricular hypertrophy
    Description

    Increased voltage consistent with left ventricular hypertrophy

    Data type

    boolean

    Other morphology
    Description

    specify

    Data type

    text

    C. Conduction
    Description

    C. Conduction

    First degree AV block (PR interval > 200 msec)
    Description

    First degree AV block (PR interval > 200 msec)

    Data type

    boolean

    Short PR interval
    Description

    Short PR interval

    Data type

    boolean

    Second degree AV block (Mobitz type 1)
    Description

    Second degree AV block (Mobitz type 1)

    Data type

    boolean

    Second degree AV block (Mobitz type 2)
    Description

    Second degree AV block (Mobitz type 2)

    Data type

    boolean

    Second degree AV block (Mobitz type 2)
    Description

    Second degree AV block (Mobitz type 2)

    Data type

    boolean

    2:1 AV block
    Description

    2:1 AV block

    Data type

    boolean

    Third degree AV block
    Description

    Third degree AV block

    Data type

    boolean

    Left axis deviation (QRS axis more negative than -30°)
    Description

    Left axis deviation (QRS axis more negative than -30°)

    Data type

    boolean

    Right axis deviation (QRS axis more positive than +110°)
    Description

    Right axis deviation (QRS axis more positive than +110°)

    Data type

    boolean

    Incomplete right bundle branch block
    Description

    Incomplete right bundle branch block

    Data type

    boolean

    Incomplete left bundle branch block
    Description

    Incomplete left bundle branch block

    Data type

    boolean

    Right bundle branch block
    Description

    Right bundle branch block

    Data type

    boolean

    Left anterior hemiblock (synonymous to left anterior fascicular block)
    Description

    Left anterior hemiblock (synonymous to left anterior fascicular block)

    Data type

    boolean

    Left posterior hemiblock (synonymous to left posterior fascicular block)
    Description

    Left posterior hemiblock (synonymous to left posterior fascicular block)

    Data type

    boolean

    Left bundle branch block
    Description

    Left bundle branch block

    Data type

    boolean

    Bifascicular block
    Description

    Bifascicular block

    Data type

    boolean

    Non-specific intraventricular conduction delay (QRS >=120msec)
    Description

    Non-specific intraventricular conduction delay (QRS >=120msec)

    Data type

    boolean

    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
    Description

    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)

    Data type

    boolean

    Prolonged QT interval
    Description

    Prolonged QT interval

    Data type

    boolean

    QT/QTc prolongation >=500 msec
    Description

    QT/QTc prolongation >=500 msec

    Data type

    boolean

    AV dissociation
    Description

    AV dissociation

    Data type

    boolean

    Other conduction
    Description

    Other conduction

    Data type

    text

    D. Myocardial Infraction
    Description

    D. Myocardial Infraction

    Myocardial infraction, old
    Description

    Myocardial infraction, old

    Data type

    boolean

    Myocardial infraction, anterior
    Description

    Myocardial infraction, anterior

    Data type

    boolean

    Myocardial infraction, lateral
    Description

    Myocardial infraction, lateral

    Data type

    boolean

    Myocardial infraction, posterior
    Description

    Myocardial infraction, posterior

    Data type

    boolean

    Myocardial infraction, inferior
    Description

    Myocardial infraction, inferior

    Data type

    boolean

    Myocardial infraction, septal
    Description

    Myocardial infraction, septal

    Data type

    boolean

    Myocardial infraction, Non-Q wave
    Description

    Myocardial infraction, Non-Q wave

    Data type

    boolean

    Other myocardial infraction
    Description

    Other myocardial infraction

    Data type

    text

    E. Depolarisation/Repolarisation (QRS-T)
    Description

    E. Depolarisation/Repolarisation (QRS-T)

    Non-specific ST-T changes
    Description

    Non-specific ST-T changes

    Data type

    boolean

    J point elevation
    Description

    J point elevation

    Data type

    boolean

    ST elevation
    Description

    ST elevation

    Data type

    boolean

    ST elevation-pericarditis
    Description

    ST elevation-pericarditis

    Data type

    boolean

    ST depression
    Description

    ST depression

    Data type

    boolean

    U waves abnormal
    Description

    U waves abnormal

    Data type

    boolean

    T wave inversion
    Description

    T wave inversion

    Data type

    boolean

    T wave peaked
    Description

    T wave peaked

    Data type

    boolean

    T waves flat
    Description

    T waves flat

    Data type

    boolean

    T waves biphasic
    Description

    T waves biphasic

    Data type

    boolean

    Notched T-waves
    Description

    Notched T-waves

    Data type

    boolean

    Low QRS voltage
    Description

    Low QRS voltage

    Data type

    boolean

    T-wave flattening/inversion
    Description

    T-wave flattening/inversion

    Data type

    boolean

    Other depolarisation/repolarisation
    Description

    Other depolarisation/repolarisation

    Data type

    text

    F. Other
    Description

    F. Other

    Other Abnormalities, enter comment
    Description

    Other Abnormalities, enter comment

    Data type

    text

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    Similar models

    Follow-Up: 12-lead ECG Abnormalities

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    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
    Item Group
    A. Rhythm
    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
    Item Group
    B. P-Wave Morphology
    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
    Item Group
    C. Conduction
    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
    Item Group
    D. Myocardial Infraction
    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
    Item Group
    E. Depolarisation/Repolarisation (QRS-T)
    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
    Item Group
    F. Other
    Other Abnormalities, enter comment
    Item
    Other Abnormalities, enter comment
    text
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