ID
30156
Beschrijving
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
Trefwoorden
Versies (1)
- 16-05-18 16-05-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
16 mei 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061
12-lead ECG Abnormalities
- StudyEvent: ODM
Beschrijving
12-Lead ECG Abnormalities: A. Rhythm
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
- UMLS CUI-3
- C0199556
Beschrijving
Sinus bradycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus bradycardia (heart rate 40-50 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus bradycardia (heart rate 30-39 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus bradycardia (heart rate < 30 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus pause
Datatype
boolean
Alias
- UMLS CUI [1]
- C1955864
Beschrijving
Sinus tachycardia (heart rate >100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0039239
Beschrijving
Ectopic supraventricular beats
Datatype
boolean
Alias
- UMLS CUI [1]
- C0033036
Beschrijving
Ectopic supraventricular rhythm
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348376
Beschrijving
Wandering atrial pacemaker
Datatype
boolean
Alias
- UMLS CUI [1]
- C1321523
Beschrijving
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0221158
Beschrijving
Supraventricular tachycardia (heart rate >100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0039240
Beschrijving
Atrial flutter
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004239
Beschrijving
Atrial Fibrillation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004238
Beschrijving
Junctional rhythm (heart rate ≤100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschrijving
Junctional rhythm
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschrijving
Junctional tachycardia (heart rate > 100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0039235
Beschrijving
Ectopic ventricular beats
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151636
Beschrijving
Ventricular couplets
Datatype
boolean
Alias
- UMLS CUI [1]
- C0429001
Beschrijving
Bigeminy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262662
Beschrijving
Trigeminy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0428999
Beschrijving
Electrical alternans
Datatype
boolean
Alias
- UMLS CUI [1]
- C1142551
Beschrijving
R on T phenomenon
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877658
Beschrijving
Ventricular Fibrillation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042510
Beschrijving
Idioventricular rhythm (heart rate < 100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0700363
Beschrijving
Sustained ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0750197
Beschrijving
Non-sustained ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0750194
Beschrijving
Wide QRS Tachycardia (diagnosis unknown)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0344429
Beschrijving
Ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042514
Beschrijving
Monomorphic ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0344431
Beschrijving
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0040479
Beschrijving
Polymorphic (sustained and non-sustained) ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0344432
Beschrijving
Artificial pacemaker
Datatype
boolean
Alias
- UMLS CUI [1]
- C0030163
Beschrijving
Other abnormal rhythm
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0199556
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0199556
- UMLS CUI [1,2]
- C0947611
Beschrijving
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
Beschrijving
Left atrial abnormality (P mitrale)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Beschrijving
Right atrial abnormality (P pulmonale)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Beschrijving
Right ventricular hypertrophy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0162770
Beschrijving
Intraatrial conduction delay
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346510
Beschrijving
Increased voltage consistent with left ventricular hypertrophy
Datatype
boolean
Alias
- UMLS CUI [1]
- C1112650
Beschrijving
Other morphology
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0332437
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0429098
- UMLS CUI [1,3]
- C0429084
- UMLS CUI [1,4]
- C0947611
Beschrijving
12-Lead ECG Abnormalities: C. Conduction
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
- UMLS CUI-3
- C0232217
Beschrijving
First degree AV block (PR interval > 200 msec)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085614
Beschrijving
Short PR interval
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520878
Beschrijving
Second degree AV block (Mobitz type 1)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264907
Beschrijving
Second degree AV block (Mobitz type 2)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0155700
Beschrijving
2:1 AV block
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346542
Beschrijving
Third degree AV block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151517
Beschrijving
Left axis deviation (QRS axis more negative than -30°)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232297
Beschrijving
Right axis deviation (QRS axis more positive than +110°)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232296
Beschrijving
Incomplete right bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262525
Beschrijving
Incomplete left bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0281878
Beschrijving
Right bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085615
Beschrijving
Left anterior hemiblock (synonymous to left anterior fascicular block)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264912
Beschrijving
Left posterior hemiblock (synonymous to left posterior fascicular block)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264913
Beschrijving
Left Bundle Branch Block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023211
Beschrijving
Bifascicular block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264914
Beschrijving
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
Datatype
boolean
Alias
- UMLS CUI [1]
- C3697597
Beschrijving
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0264897
- UMLS CUI [1,2]
- C0043202
Beschrijving
Prolonged QT interval
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151878
Beschrijving
QT/QTc prolongation ≥ 500 msec
Datatype
boolean
Alias
- UMLS CUI [1]
- C0855333
Beschrijving
AV dissociation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004331
Beschrijving
Other conduction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0522055
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0232217
- UMLS CUI [1,3]
- C0947611
Beschrijving
12-Lead ECG Abnormalities: D. Myocardial Infarction
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
- UMLS CUI-3
- C0027051
Beschrijving
Myocardial infarction, old
Datatype
boolean
Alias
- UMLS CUI [1]
- C0155668
Beschrijving
Myocardial infarction, anterior
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340293
Beschrijving
Myocardial infarction, lateral
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340312
Beschrijving
Myocardial infarction, posterior
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340319
Beschrijving
Myocardial infarction, inferior
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340305
Beschrijving
Myocardial infarction, septal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0746727
Beschrijving
Myocardial infarction, Non-Q wave
Datatype
boolean
Alias
- UMLS CUI [1]
- C0542269
Beschrijving
Other myocardial infarction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0522055
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0947611
Beschrijving
12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
- UMLS CUI-3
- C0948857
Beschrijving
Non-specific ST-T changes
Datatype
boolean
Alias
- UMLS CUI [1]
- C1112720
Beschrijving
J point elevation
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346597
Beschrijving
ST elevation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520886
Beschrijving
ST elevation-pericarditis
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348119
Beschrijving
ST depression
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520887
Beschrijving
ST segment abnormality, not specified
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348120
Beschrijving
U waves abnormal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0438169
Beschrijving
T wave inversion
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520888
Beschrijving
T wave peaked
Datatype
boolean
Alias
- UMLS CUI [1]
- C0239242
Beschrijving
T waves flat
Datatype
boolean
Alias
- UMLS CUI [1]
- C2215959
Beschrijving
T waves biphasic
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348639
Beschrijving
Notched T-waves
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347367
Beschrijving
Low QRS voltage
Datatype
boolean
Alias
- UMLS CUI [1]
- C2349945
Beschrijving
T-wave flattening/inversion
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0520888
- UMLS CUI [1,2]
- C0429059
Beschrijving
T wave abnormality, not specified
Datatype
boolean
Alias
- UMLS CUI [1]
- C0438167
Beschrijving
Other depolarisation/repolarisation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0948857
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0948857
- UMLS CUI [1,2]
- C0947611
Beschrijving
12-Lead ECG Abnormalities: Other Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
Similar models
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])