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41256

Descrizione

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Keywords

  1. 27/07/20 27/07/20 -
Titolare del copyright

GlaxoSmithKline

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27 luglio 2020

DOI

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Creative Commons BY 4.0

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    Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

    12-Lead ECG Abnormalities; Holter ECG Abnormalities; ECG Abnormalities (Lead II Monitoring)

    Administrative
    Descrizione

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descrizione

    Subject Identifier

    Tipo di dati

    text

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

    12-Lead ECG Abnormalities

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

    Date of ECG

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C2826640
    Time of ECG
    Descrizione

    Time of ECG

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    12-Lead ECG Abnormalities
    Descrizione

    12-Lead ECG Abnormalities

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C1704258
    A. Rhythm
    Descrizione

    A. Rhythm

    Tipo di dati

    text

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

    A. Rhythm - Comment

    Tipo di dati

    text

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

    B. P-Wave and QRS Morphology

    Tipo di dati

    text

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

    B. P-Wave and QRS Morphology - Comment

    Tipo di dati

    text

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

    C. Conduction

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0232217
    C. Conduction - Comment
    Descrizione

    C. Conduction - Comment

    Tipo di dati

    text

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

    D. Myocardial Infarction

    Tipo di dati

    text

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

    D. Myocardial Infarction - Comment

    Tipo di dati

    text

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

    E. Depolarisation/ Repolarisation (QRS-T)

    Tipo di dati

    text

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

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

    Tipo di dati

    text

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

    Other Abnormalities

    Tipo di dati

    text

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

    Other Abnormalities - Comment

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0947611
    Holter ECG Abnormalities
    Descrizione

    Holter ECG Abnormalities

    Alias
    UMLS CUI-1
    C0013801
    UMLS CUI-2
    C0522055
    Date of ECG
    Descrizione

    Date of ECG

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C2826640
    Time of ECG
    Descrizione

    Time of ECG

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    12-Lead ECG Abnormalities
    Descrizione

    12-Lead ECG Abnormalities

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C1704258
    A. Rhythm
    Descrizione

    A. Rhythm

    Tipo di dati

    text

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

    A. Rhythm - Comment

    Tipo di dati

    text

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

    B. P-Wave and QRS Morphology

    Tipo di dati

    text

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

    B. P-Wave and QRS Morphology - Comment

    Tipo di dati

    text

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

    C. Conduction

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0232217
    C. Conduction - Comment
    Descrizione

    C. Conduction - Comment

    Tipo di dati

    text

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

    D. Myocardial Infarction

    Tipo di dati

    text

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

    D. Myocardial Infarction - Comment

    Tipo di dati

    text

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

    E. Depolarisation/ Repolarisation (QRS-T)

    Tipo di dati

    text

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

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

    Tipo di dati

    text

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

    Other Abnormalities

    Tipo di dati

    text

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

    Other Abnormalities - Comment

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0947611
    ECG Abnormalities (Lead II Monitoring)
    Descrizione

    ECG Abnormalities (Lead II Monitoring)

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

    Date of ECG

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C2826640
    Time of ECG
    Descrizione

    Time of ECG

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013798
    ECG Abnormalities (Lead II Monitoring)
    Descrizione

    ECG Abnormalities (Lead II Monitoring)

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C1704258
    A. Rhythm
    Descrizione

    A. Rhythm

    Tipo di dati

    text

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

    A. Rhythm - Comment

    Tipo di dati

    text

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

    B. P-Wave and QRS Morphology

    Tipo di dati

    text

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

    B. P-Wave and QRS Morphology - Comment

    Tipo di dati

    text

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

    C. Conduction

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0232217
    C. Conduction - Comment
    Descrizione

    C. Conduction - Comment

    Tipo di dati

    text

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

    D. Myocardial Infarction

    Tipo di dati

    text

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

    D. Myocardial Infarction - Comment

    Tipo di dati

    text

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

    E. Depolarisation/ Repolarisation (QRS-T)

    Tipo di dati

    text

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

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

    Tipo di dati

    text

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

    Other Abnormalities

    Tipo di dati

    text

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

    Other Abnormalities - Comment

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0947611

    Similar models

    12-Lead ECG Abnormalities; Holter ECG Abnormalities; ECG Abnormalities (Lead II Monitoring)

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    12-Lead ECG Abnormalities
    C0430456 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    Date of ECG
    Item
    Date of ECG
    date
    C2826640 (UMLS CUI [1])
    Time of ECG
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    Item Group
    12-Lead ECG Abnormalities
    C0430456 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    Item
    A. Rhythm
    text
    C0232187 (UMLS CUI [1])
    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 artrial pacemaker (A17)
    CL Item
    Trigeminy (A26)
    CL Item
    Supraventricular tachycardia (heart rate >100 beats/min) (A6)
    CL Item
    Artrial flutter (A7)
    CL Item
    Atrial fibrillation (A8)
    CL Item
    Junctional rhythm (heart rate <=100 beats/min) (A5)
    CL Item
    Junctional tachycardia (heart rate >100 beats/min) (A25)
    CL Item
    Ectopic vetricular beats (A9)
    CL Item
    Ventricular couplets (A12)
    CL Item
    Bigeminy (A13)
    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
    Wide QRS Tachycardia (diagnosis unknown) (A32)
    CL Item
    Ventricular tachycardia (A27)
    CL Item
    Monomorphic ventricular tachycardia (A30)
    CL Item
    Torsade 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])
    C0947611 (UMLS CUI [2])
    Item
    B. P-Wave and QRS Morphology
    text
    C2216025 (UMLS CUI [1,1])
    C0429098 (UMLS CUI [1,2])
    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
    Intraartrial 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 [2])
    Item
    C. Conduction
    text
    C0232217 (UMLS CUI [1])
    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 negaative 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 >= 120msec) (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 dissocation (C18)
    CL Item
    Other conduction (C99)
    C. Conduction - Comment
    Item
    C. Conduction - Comment
    text
    C0232217 (UMLS CUI [1])
    C0947611 (UMLS CUI [2])
    Item
    D. Myocardial Infarction
    text
    C0027051 (UMLS CUI [1])
    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, spetal (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])
    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/ repolatisation (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 [2])
    Item
    Other Abnormalities
    text
    C0522055 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    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 [2])
    Item Group
    Holter ECG Abnormalities
    C0013801 (UMLS CUI-1)
    C0522055 (UMLS CUI-2)
    Date of ECG
    Item
    Date of ECG
    date
    C2826640 (UMLS CUI [1])
    Time of ECG
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    Item Group
    12-Lead ECG Abnormalities
    C0430456 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    Item
    A. Rhythm
    text
    C0232187 (UMLS CUI [1])
    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 artrial 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
    Artrial 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 vetricular 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
    Wide QRS Tachycardia (diagnosis unknown) (A32)
    CL Item
    Ventricular tachycardia (A27)
    CL Item
    Monomorphic ventricular tachycardia (A30)
    CL Item
    Torsade 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])
    C0947611 (UMLS CUI [2])
    Item
    B. P-Wave and QRS Morphology
    text
    C2216025 (UMLS CUI [1,1])
    C0429098 (UMLS CUI [1,2])
    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
    Intraartrial 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 [2])
    Item
    C. Conduction
    text
    C0232217 (UMLS CUI [1])
    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 negaative 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 >= 120msec) (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 dissocation (C18)
    CL Item
    Other conduction (C99)
    C. Conduction - Comment
    Item
    C. Conduction - Comment
    text
    C0232217 (UMLS CUI [1])
    C0947611 (UMLS CUI [2])
    Item
    D. Myocardial Infarction
    text
    C0027051 (UMLS CUI [1])
    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, spetal (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])
    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/ repolatisation (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 [2])
    Item
    Other Abnormalities
    text
    C0522055 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    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 [2])
    Item Group
    ECG Abnormalities (Lead II Monitoring)
    C0430456 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    Date of ECG
    Item
    Date of ECG
    date
    C2826640 (UMLS CUI [1])
    Time of ECG
    Item
    Time of ECG
    time
    C0040223 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    Item Group
    ECG Abnormalities (Lead II Monitoring)
    C0430456 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    Item
    A. Rhythm
    text
    C0232187 (UMLS CUI [1])
    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 artrial 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
    Artrial 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 vetricular 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
    Wide QRS Tachycardia (diagnosis unknown) (A32)
    CL Item
    Ventricular tachycardia (A27)
    CL Item
    Monomorphic ventricular tachycardia (A30)
    CL Item
    Torsade 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])
    C0947611 (UMLS CUI [2])
    Item
    B. P-Wave and QRS Morphology
    text
    C2216025 (UMLS CUI [1,1])
    C0429098 (UMLS CUI [1,2])
    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
    Intraartrial 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 [2])
    Item
    C. Conduction
    text
    C0232217 (UMLS CUI [1])
    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 negaative 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 >= 120msec) (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 dissocation (C18)
    CL Item
    Other conduction (C99)
    C. Conduction - Comment
    Item
    C. Conduction - Comment
    text
    C0232217 (UMLS CUI [1])
    C0947611 (UMLS CUI [2])
    Item
    D. Myocardial Infarction
    text
    C0027051 (UMLS CUI [1])
    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, spetal (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])
    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/ repolatisation (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 [2])
    Item
    Other Abnormalities
    text
    C0522055 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    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 [2])

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