0 Evaluaciones
ID

32671

Descripción

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

Palabras clave

Versiones (1)
  1. 11/11/18 11/11/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

11 de noviembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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    Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

    Inglés

    ECG Abnormalities

    1 formularios  
    1. StudyEvent: ODM
      1. ECG Abnormalities
    12-Lead ECG Abnormalities
    Descripción

    12-Lead ECG Abnormalities

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C1704258
    Date and Time of ECG
    Descripción

    12 lead ECG, Date in time, Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Record clinically significant abnormalities - Rhythm
    Descripción

    12 lead ECG, Abnormality, Cardiac rhythm type

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0232187
    Record clinically significant abnormalities - P-Wave Morphology
    Descripción

    12 lead ECG, Abnormality, P wave shifting morphology

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C2216025
    Record clinically significant abnormalities - Conduction
    Descripción

    12 lead ECG, Abnormality, Cardiac conduction

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0232217
    Record clinically significant abnormalities - Myocardial Infarction
    Descripción

    12 lead ECG, Abnormality, Myocardial Infarction

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0027051
    Record clinically significant abnormalities - Depolarisation/Repolarisation (QRS-T)
    Descripción

    12 lead ECG, Abnormality, Electrocardiogram repolarisation abnormality, Ventricular Depolarization

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0948857
    UMLS CUI [1,4]
    C1331539
    Other abnormalities
    Descripción

    12 lead ECG, Abnormality, Other

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0205394
    Volver a la parte superior de la página

    Similar models

    ECG Abnormalities

    1 formularios
    1. StudyEvent: ODM
      1. ECG Abnormalities
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    12-Lead ECG Abnormalities
    C0430456 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    12 lead ECG, Date in time, Time
    Item
    Date and Time of ECG
    datetime
    C0430456 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    Record clinically significant abnormalities - Rhythm
    text
    C0430456 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0232187 (UMLS CUI [1,3])
    12 lead ECG, Abnormality, Cardiac rhythm type
    Code List
    Record clinically significant abnormalities - 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 w/rate >100 beats/min) 11=Supraventricular tachycardia (heart rate>100 beats/min) (10)
    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
    Idioventricular rhythm (24)
    CL Item
    Sustained ventricular tachycardia (25)
    CL Item
    Non-sustained ventricular tachycardia (26)
    CL Item
    Wide QRS tachycardia (diagnosis unknown) (27)
    CL Item
    Ventricular tachycardia (28)
    CL Item
    Monomorphic ventricular tachycardia (29)
    CL Item
    Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)  (30)
    CL Item
    Polymorphic (sustained and non-sustained) ventricular tachycardia (31)
    CL Item
    Artificial Pacemaker (32)
    CL Item
    Other abnormal rhythm (33)
    Item
    Record clinically significant abnormalities - P-Wave Morphology
    text
    C0430456 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C2216025 (UMLS CUI [1,3])
    12 lead ECG, Abnormality, Cardiac rhythm type
    Code List
    Record clinically significant abnormalities - P-Wave 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
    Intraatrial conduction delay (4)
    CL Item
    Increased voltage consistent with left ventricular hypertrophy (5)
    CL Item
    Other morphology (6)
    Item
    Record clinically significant abnormalities - Conduction
    text
    C0430456 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0232217 (UMLS CUI [1,3])
    12 lead ECG, Abnormality, Cardiac rhythm type
    Code List
    Record clinically significant abnormalities - Conduction
    CL Item
    First degree AV block (PR interval > 200msec) (1)
    CL Item
    Short PR interval (2)
    CL Item
    Second degree AV block (Mobitz type 1) (3)
    CL Item
    Second degree AV block (Mobitz type 2) (4)
    CL Item
    2:1 AV block (5)
    CL Item
    Third degree AV block (6)
    CL Item
    Left axis deviation (QRS axis more negative than -30 degrees) (7)
    CL Item
    Right axis deviation (QRS axis more positive than +110 degrees)  (8)
    CL Item
    Incomplete right bundle branch block (9)
    CL Item
    Incomplete left bundle branch block (10)
    CL Item
    Right bundle branch block (11)
    CL Item
    Left anterior hemiblock (synonymous to left anterior fascicular block)  (12)
    CL Item
    Left posterior hemiblock (synonymous to left posterior fascicular block)  (13)
    CL Item
    Left bundle branch block (14)
    CL Item
    Bifascicular block (15)
    CL Item
    Non-specific intraventricular conduction delay (QRS > 120 msec)  (16)
    CL Item
    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)  (17)
    CL Item
    Prolonged QT interval (18)
    CL Item
    QT/QTc prolongation > 500 msec (19)
    CL Item
    AV dissociation (20)
    CL Item
    Other conduction (21)
    Item
    Record clinically significant abnormalities - Myocardial Infarction
    text
    C0430456 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0027051 (UMLS CUI [1,3])
    12 lead ECG, Abnormality, Cardiac rhythm type
    Code List
    Record clinically significant abnormalities - 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
    Record clinically significant abnormalities - Depolarisation/Repolarisation (QRS-T)
    text
    C0430456 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0948857 (UMLS CUI [1,3])
    C1331539 (UMLS CUI [1,4])
    12 lead ECG, Abnormality, Cardiac rhythm type
    Code List
    Record clinically significant abnormalities - 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])
    Volver a la parte superior de la página 

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