0 Évaluations
ID

32671

Description

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

Mots-clés

Versions (1)
  1. 11/11/2018 11/11/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

11 novembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

    Aucun commentaire

    Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

    Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

    Anglais

    ECG Abnormalities

    1 Formulaires  
    1. StudyEvent: ODM
      1. ECG Abnormalities
    12-Lead ECG Abnormalities
    Description

    12-Lead ECG Abnormalities

    Alias
    UMLS CUI-1
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI-2
    C1704258 (Abnormality)
    Date and Time of ECG
    Description

    12 lead ECG, Date in time, Time

    Type de données

    datetime

    Alias
    UMLS CUI [1,1]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Record clinically significant abnormalities - Rhythm
    Description

    12 lead ECG, Abnormality, Cardiac rhythm type

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI [1,2]
    C1704258 (Abnormality)
    UMLS CUI [1,3]
    C0232187 (Cardiac rhythm type)
    SNOMED
    251149006
    LOINC
    LP133264-4
    Record clinically significant abnormalities - P-Wave Morphology
    Description

    12 lead ECG, Abnormality, P wave shifting morphology

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI [1,2]
    C1704258 (Abnormality)
    UMLS CUI [1,3]
    C2216025 (electrocardiogram: P wave shifting morphology)
    Record clinically significant abnormalities - Conduction
    Description

    12 lead ECG, Abnormality, Cardiac conduction

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI [1,2]
    C1704258 (Abnormality)
    UMLS CUI [1,3]
    C0232217 (Cardiac conduction)
    SNOMED
    251089002
    LOINC
    LP31561-1
    Record clinically significant abnormalities - Myocardial Infarction
    Description

    12 lead ECG, Abnormality, Myocardial Infarction

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI [1,2]
    C1704258 (Abnormality)
    UMLS CUI [1,3]
    C0027051 (Myocardial Infarction)
    SNOMED
    22298006
    Record clinically significant abnormalities - Depolarisation/Repolarisation (QRS-T)
    Description

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

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI [1,2]
    C1704258 (Abnormality)
    UMLS CUI [1,3]
    C0948857 (Electrocardiogram repolarisation abnormality)
    UMLS CUI [1,4]
    C1331539 (Ventricular Depolarization [PE])
    Other abnormalities
    Description

    12 lead ECG, Abnormality, Other

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI [1,2]
    C1704258 (Abnormality)
    UMLS CUI [1,3]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Retour au début de la page

    Similar models

    ECG Abnormalities

    1 Formulaires
    1. StudyEvent: ODM
      1. ECG Abnormalities
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

    Aide

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial