ID
30156
Beschreibung
Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: 12-lead ECG Abnormalities
Link
https://clinicaltrials.gov/ct2/show/NCT01036061
Stichworte
Versionen (1)
- 16.05.18 16.05.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
16. Mai 2018
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061
12-lead ECG Abnormalities
- StudyEvent: ODM
Beschreibung
12-Lead ECG Abnormalities: A. Rhythm
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
- UMLS CUI-3
- C0199556
Beschreibung
Sinus bradycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
Sinus bradycardia (heart rate 40-50 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
Sinus bradycardia (heart rate 30-39 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
Sinus bradycardia (heart rate < 30 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschreibung
Sinus pause
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1955864
Beschreibung
Sinus tachycardia (heart rate >100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0039239
Beschreibung
Ectopic supraventricular beats
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0033036
Beschreibung
Ectopic supraventricular rhythm
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348376
Beschreibung
Wandering atrial pacemaker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1321523
Beschreibung
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0221158
Beschreibung
Supraventricular tachycardia (heart rate >100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0039240
Beschreibung
Atrial flutter
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004239
Beschreibung
Atrial Fibrillation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004238
Beschreibung
Junctional rhythm (heart rate ≤100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschreibung
Junctional rhythm
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschreibung
Junctional tachycardia (heart rate > 100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0039235
Beschreibung
Ectopic ventricular beats
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151636
Beschreibung
Ventricular couplets
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0429001
Beschreibung
Bigeminy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262662
Beschreibung
Trigeminy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0428999
Beschreibung
Electrical alternans
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1142551
Beschreibung
R on T phenomenon
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0877658
Beschreibung
Ventricular Fibrillation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0042510
Beschreibung
Idioventricular rhythm (heart rate < 100 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0700363
Beschreibung
Sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750197
Beschreibung
Non-sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750194
Beschreibung
Wide QRS Tachycardia (diagnosis unknown)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0344429
Beschreibung
Ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0042514
Beschreibung
Monomorphic ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0344431
Beschreibung
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0040479
Beschreibung
Polymorphic (sustained and non-sustained) ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0344432
Beschreibung
Artificial pacemaker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030163
Beschreibung
Other abnormal rhythm
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0199556
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0199556
- UMLS CUI [1,2]
- C0947611
Beschreibung
12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
- UMLS CUI-3
- C0429098
- UMLS CUI-4
- C0429084
Beschreibung
Left atrial abnormality (P mitrale)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Beschreibung
Right atrial abnormality (P pulmonale)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Beschreibung
Right ventricular hypertrophy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0162770
Beschreibung
Intraatrial conduction delay
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346510
Beschreibung
Increased voltage consistent with left ventricular hypertrophy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1112650
Beschreibung
Other morphology
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0332437
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0429098
- UMLS CUI [1,3]
- C0429084
- UMLS CUI [1,4]
- C0947611
Beschreibung
12-Lead ECG Abnormalities: C. Conduction
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
- UMLS CUI-3
- C0232217
Beschreibung
First degree AV block (PR interval > 200 msec)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085614
Beschreibung
Short PR interval
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520878
Beschreibung
Second degree AV block (Mobitz type 1)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264907
Beschreibung
Second degree AV block (Mobitz type 2)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155700
Beschreibung
2:1 AV block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346542
Beschreibung
Third degree AV block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151517
Beschreibung
Left axis deviation (QRS axis more negative than -30°)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232297
Beschreibung
Right axis deviation (QRS axis more positive than +110°)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232296
Beschreibung
Incomplete right bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262525
Beschreibung
Incomplete left bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0281878
Beschreibung
Right bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085615
Beschreibung
Left anterior hemiblock (synonymous to left anterior fascicular block)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264912
Beschreibung
Left posterior hemiblock (synonymous to left posterior fascicular block)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264913
Beschreibung
Left Bundle Branch Block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023211
Beschreibung
Bifascicular block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264914
Beschreibung
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3697597
Beschreibung
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0264897
- UMLS CUI [1,2]
- C0043202
Beschreibung
Prolonged QT interval
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151878
Beschreibung
QT/QTc prolongation ≥ 500 msec
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0855333
Beschreibung
AV dissociation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004331
Beschreibung
Other conduction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0522055
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0232217
- UMLS CUI [1,3]
- C0947611
Beschreibung
12-Lead ECG Abnormalities: D. Myocardial Infarction
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
- UMLS CUI-3
- C0027051
Beschreibung
Myocardial infarction, old
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155668
Beschreibung
Myocardial infarction, anterior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340293
Beschreibung
Myocardial infarction, lateral
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340312
Beschreibung
Myocardial infarction, posterior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340319
Beschreibung
Myocardial infarction, inferior
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340305
Beschreibung
Myocardial infarction, septal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0746727
Beschreibung
Myocardial infarction, Non-Q wave
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0542269
Beschreibung
Other myocardial infarction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0522055
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0947611
Beschreibung
12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
- UMLS CUI-3
- C0948857
Beschreibung
Non-specific ST-T changes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1112720
Beschreibung
J point elevation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346597
Beschreibung
ST elevation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520886
Beschreibung
ST elevation-pericarditis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348119
Beschreibung
ST depression
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520887
Beschreibung
ST segment abnormality, not specified
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348120
Beschreibung
U waves abnormal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0438169
Beschreibung
T wave inversion
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520888
Beschreibung
T wave peaked
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0239242
Beschreibung
T waves flat
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2215959
Beschreibung
T waves biphasic
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348639
Beschreibung
Notched T-waves
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347367
Beschreibung
Low QRS voltage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2349945
Beschreibung
T-wave flattening/inversion
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0520888
- UMLS CUI [1,2]
- C0429059
Beschreibung
T wave abnormality, not specified
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0438167
Beschreibung
Other depolarisation/repolarisation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0948857
Beschreibung
Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0948857
- UMLS CUI [1,2]
- C0947611
Beschreibung
12-Lead ECG Abnormalities: Other Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
Ähnliche Modelle
12-lead ECG Abnormalities
- StudyEvent: ODM
C0522055 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0522055 (UMLS CUI-2)
C0199556 (UMLS CUI-3)
C0199556 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0522055 (UMLS CUI-2)
C0429098 (UMLS CUI-3)
C0429084 (UMLS CUI-4)
C0232310 (UMLS CUI [1,2])
C0232308 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,2])
C0429098 (UMLS CUI [1,2])
C0429084 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0522055 (UMLS CUI-2)
C0232217 (UMLS CUI-3)
C0043202 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0522055 (UMLS CUI-2)
C0027051 (UMLS CUI-3)
C0522055 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0522055 (UMLS CUI-2)
C0948857 (UMLS CUI-3)
C0429059 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0522055 (UMLS CUI-2)
C0522055 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])