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40950

Beschreibung

The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitus Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

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Versionen (2)
  1. 23.04.20 23.04.20 -
  2. 07.06.20 07.06.20 -
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GlaxoSmithKline

Hochgeladen am

7. Juni 2020

DOI

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    A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin

    Englisch

    ECG Abnormalities - Repeating Form, Logs/Repeats 8-RF-DF

    1 Formulare  
    12-LEAD ECG ABNORMALITIES
    Beschreibung

    12-LEAD ECG ABNORMALITIES

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

    Date and Time ECG

    Datentyp

    datetime

    Alias
    UMLS CUI [1]
    C2826846
    2. Record clinically significant abnormalities- A. Rhythm
    Beschreibung

    12 Lead ECG abnormalities Rhythm

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0199556
    Other abnormal rhythm, enter comment
    Beschreibung

    other rhythm abnormal

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0199556
    UMLS CUI [1,3]
    C0205161
    UMLS CUI [1,4]
    C0947611
    2. Record clinically significant abnormalities- B. P-Wave Morphology
    Beschreibung

    12 Lead ECG abnormalities Morphology

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0429072
    Other morphology, enter comment
    Beschreibung

    Other morphology

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0332437
    UMLS CUI [1,3]
    C0430456
    UMLS CUI [1,4]
    C1704258
    UMLS CUI [1,5]
    C0947611
    2. Record clinically significant abnormalities- C. Conduction
    Beschreibung

    12 Lead ECG abnormalities Cardiac conduction

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0232217
    Other conduction, enter comment
    Beschreibung

    Other conduction

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0232217
    UMLS CUI [1,3]
    C0430456
    UMLS CUI [1,4]
    C1704258
    UMLS CUI [1,5]
    C0947611
    UMLS CUI [1,6]
    C0947611
    2. Record clinically significant abnormalities- D. Myocardial Infarction
    Beschreibung

    12 Lead ECG abnormalities Myocardial Infarction

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0027051
    Other myocardial infarction, enter comment
    Beschreibung

    Other myocardial infarction

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0027051
    UMLS CUI [1,3]
    C0947611
    2. Record clinically significant abnormalities- E. Depolarisation/Repolarisation (QRS-T)
    Beschreibung

    12 Lead ECG abnormalities

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [2]
    C0948857
    Other depolarisation/repolarisation, enter comment
    Beschreibung

    Other repolarisation

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0430456
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [1,4]
    C0947611
    UMLS CUI [2,1]
    C0205394
    UMLS CUI [2,2]
    C0948857
    UMLS CUI [2,3]
    C0947611
    2. Record clinically significant abnormalities- Other abnormalities, enter comment
    Beschreibung

    E99

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C0947611
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    ECG Abnormalities - Repeating Form, Logs/Repeats 8-RF-DF

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    12-LEAD ECG ABNORMALITIES
    C0430456 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    Date and Time ECG
    Item
    1. Date and Time of ECG
    datetime
    C2826846 (UMLS CUI [1])
    Item
    2. Record clinically significant abnormalities- A. Rhythm
    text
    C0430456 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0199556 (UMLS CUI [1,3])
    undefined item
    Code List
    2. Record clinically significant abnormalities- A. Rhythm
    CL Item
    Sinus bradycardia  (A1)
    C0085610 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Sinus bradycardia (heart rate 40-50 beats/min)  (A21)
    C0085610 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Sinus bradycardia (heart rate 30-39 beats/min) (A22)
    C0085610 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Sinus bradycardia (heart rate <30 beats/min)  (A23)
    C0085610 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Sinus pause  (A3)
    C0541782 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Sinus tachycardia (heart rate> 100 beats/min)  (A2)
    C0039239 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Ectopic supraventricular beats (A4)
    C0033036 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Ectopic supraventricular rhythm (A20)
    C2348376 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Wandering atrial pacemaker (A17)
    C1321523 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Multifocal atrial tachycardia (wandering atrial pacemaker w/rate > I 00 beats/min)  (A26)
    C0221158 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Supra ventricular tachycardia (heart rate> I 00 beat/min)  (A6)
    C0039240 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Atrial flutter (A7)
    C0004239 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Atrial fibrillation  (A8)
    C0004238 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Junctional rhythm (heart rate<= 100 beat /min)  (A5)
    C0232208 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Junctional rhythm  (A25)
    C0232208 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Junctional tachycardia (heart rate> I 00 beats/min)  (A24)
    C0039235 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Ectopic ventricular beats  (A9)
    C0151636 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Ventricular couplets (A12)
    C0429001 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Bigeminy  (A13)
    C0262662 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Trigeminy  (A28)
    C0428999 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Electrical alternans (A14)
    C1142551 (UMLS CUI-1)
    (Comment:en)
    CL Item
    R on T phenomenon  (A29)
    C0877658 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Ventricular fibrillation  (A18)
    C0042510 (UMLS CUI-1)
    (Comment:en)
    CL Item
    ldioventricular rhythm  (A19)
    C0700363 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Sustained ventricular tachycardia (A10)
    C0750197 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Non-sustained ventricular tachycardia (A11)
    C0750194 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Ventricular tachycardia  (A27)
    C0042514 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Monomorphic ventricular tachycardia  (A30)
    C0344431 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)  (A15)
    C0040479 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Polymorphic (sustained and non-sustained) ventricular tachycardia  (A31)
    C0344432 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Artificial Pacemaker (A16)
    C0030163 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Other abnormal rhvthm, enter comment (A99)
    C0205394 (UMLS CUI-1)
    C0199556 (UMLS CUI-2)
    C0205161 (UMLS CUI-3)
    (Comment:en)
    CL Item
    Wide QRS tachycardia (diagnosis unknown) (A32)
    other rhythm abnormal
    Item
    Other abnormal rhythm, enter comment
    text
    C0205394 (UMLS CUI [1,1])
    C0199556 (UMLS CUI [1,2])
    C0205161 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [1,4])
    Item
    2. Record clinically significant abnormalities- B. P-Wave Morphology
    text
    C0430456 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0429072 (UMLS CUI [1,3])
    undefined item
    Code List
    2. Record clinically significant abnormalities- B. P-Wave Morphology
    CL Item
    Left atrial abnormality (P mitrale) (B1)
    C0344711 (UMLS CUI-1)
    C0232310 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Right atrial abnormality (P pulmonale) (B2)
    C0344696 (UMLS CUI-1)
    C0232308 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Right ventricular hypertrophy (B3)
    C0162770 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Intraatrial conduction delay (B5)
    C2346510 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Increased voltage consistent with left ventricular hypertrophy (D14)
    C1112650 (UMLS CUI-1)
    (Comment:en)
    CL Item
    other morphology, enter comment (B99)
    C0205394 (UMLS CUI-1)
    C0522055 (UMLS CUI-2)
    C0332437 (UMLS CUI-3)
    (Comment:en)
    Other morphology
    Item
    Other morphology, enter comment
    text
    C0205394 (UMLS CUI [1,1])
    C0332437 (UMLS CUI [1,2])
    C0430456 (UMLS CUI [1,3])
    C1704258 (UMLS CUI [1,4])
    C0947611 (UMLS CUI [1,5])
    Item
    2. Record clinically significant abnormalities- C. Conduction
    text
    C0430456 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0232217 (UMLS CUI [1,3])
    undefined item
    Code List
    2. Record clinically significant abnormalities- C. Conduction
    CL Item
    First degree AV block (PR interval> 200msec) (C1)
    C0085614 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Second degree AV block (Mobitz type 1)  (C2)
    C0264907 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Second degree AV block (Mobitz type 2)  (C3)
    C0155700 (UMLS CUI-1)
    (Comment:en)
    CL Item
    2: 1 AV block  (C16)
    C2346542 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Third degree AV block  (C4)
    C0151517 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Left axis deviation (QRS axis more negative than -30 degrees)  (C5)
    C0232297 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Right axis deviation (QRS axis more positive than+ 110 degrees)  (C6)
    C0232296 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Incomplete right bundle branch block  (C7)
    C0262525 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Incomplete left bundle branch block  (C13)
    C0281878 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Right bundle branch block (C8)
    C0085615 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Left anterior hemiblock (synonymous to left anterior fascicular block)  (C14)
    C0264912 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Left posterior hemiblock (synonymous to left posterior fascicular block)  (C15)
    C0264913 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Left bundle branch block (C9)
    C0023211 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Bifascicular block  (C17)
    C0264914 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Non-specific intraventricular conduction delay (QRS >= 120 msec)  (C10)
    C3697597 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
    C0264897 (UMLS CUI-1)
    C0043202 (UMLS CUI-2)
    (Comment:en)
    CL Item
    QT/QTc prolongation >=500msec (C12)
    C0855333 (UMLS CUI-1)
    (Comment:en)
    CL Item
    AV dissociation (C18)
    C0004331 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Other conduction, enter comment (C99)
    C0205394 (UMLS CUI-1)
    C0232217 (UMLS CUI-2)
    C0522055 (UMLS CUI-3)
    (Comment:en)
    CL Item
    Short PR interval (C20)
    CL Item
    Prolonged QT interval (C19)
    Other conduction
    Item
    Other conduction, enter comment
    text
    C0205394 (UMLS CUI [1,1])
    C0232217 (UMLS CUI [1,2])
    C0430456 (UMLS CUI [1,3])
    C1704258 (UMLS CUI [1,4])
    C0947611 (UMLS CUI [1,5])
    C0947611 (UMLS CUI [1,6])
    Item
    2. Record clinically significant abnormalities- D. Myocardial Infarction
    text
    C0430456 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0027051 (UMLS CUI [1,3])
    undefined item
    Code List
    2. Record clinically significant abnormalities- D. Myocardial Infarction
    CL Item
    Myocardial infarction, old  (D1)
    C0155668 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Myocardial infarction, anterior  (D2)
    C0340293 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Myocardial infarction, lateral  (D3)
    C0340312 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Myocardial infarction, posterior  (D4)
    C0340319 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Myocardial infarction, inferior  (D5)
    C0340305 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Myocardial infarction, septal  (D6)
    C0746727 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Myocardial infarction, Non Q-wave  (D20)
    C0542269 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Other myocardial infarction, enter comment (D98)
    C0205394 (UMLS CUI-1)
    C0027051 (UMLS CUI-2)
    (Comment:en)
    Other myocardial infarction
    Item
    Other myocardial infarction, enter comment
    text
    C0205394 (UMLS CUI [1,1])
    C0027051 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item
    2. Record clinically significant abnormalities- E. Depolarisation/Repolarisation (QRS-T)
    text
    C0430456 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0948857 (UMLS CUI [2])
    undefined item
    Code List
    2. Record clinically significant abnormalities- E. Depolarisation/Repolarisation (QRS-T)
    CL Item
    Non-specific ST-T changes  (D7)
    C1112720 (UMLS CUI-1)
    (Comment:en)
    CL Item
    J point elevation  (D19)
    C2346597 (UMLS CUI-1)
    (Comment:en)
    CL Item
    ST elevation  (D8)
    C0520886 (UMLS CUI-1)
    (Comment:en)
    CL Item
    ST-elevation - pericarditis  (D21)
    C2348119 (UMLS CUI-1)
    (Comment:en)
    CL Item
    ST depression  (D9)
    C0520887 (UMLS CUI-1)
    (Comment:en)
    CL Item
    U waves abnormal (D10)
    C0438169 (UMLS CUI-1)
    (Comment:en)
    CL Item
    T wave inversion  (D11)
    C0520888 (UMLS CUI-1)
    (Comment:en)
    CL Item
    T wave peaked  (D12)
    C0239242 (UMLS CUI-1)
    (Comment:en)
    CL Item
    T waves flat  (D15)
    C2215959 (UMLS CUI-1)
    (Comment:en)
    CL Item
    T waves biphasic  (D16)
    C2348639 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Notched T-waves  (D18)
    C2347367 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Low QRS voltage  (D13)
    C2349945 (UMLS CUI-1)
    (Comment:en)
    CL Item
    T-wave flattening/inversion  (D17)
    C0520888 (UMLS CUI-1)
    C0429059 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Other depolarisation/repolarisation, enter comment (D99)
    C0205394 (UMLS CUI-1)
    C0948857 (UMLS CUI-2)
    (Comment:en)
    Other repolarisation
    Item
    Other depolarisation/repolarisation, enter comment
    text
    C0205394 (UMLS CUI [1,1])
    C0430456 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [2,1])
    C0948857 (UMLS CUI [2,2])
    C0947611 (UMLS CUI [2,3])
    other 12 Lead ECG abnormalities
    Item
    2. Record clinically significant abnormalities- Other abnormalities, enter comment
    text
    C0430456 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [1,4])
    Zum Seitenanfang zurückkehren 

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