ID
30156
Description
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
Keywords
Versions (1)
- 5/16/18 5/16/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 16, 2018
DOI
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License
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
Description
12-Lead ECG Abnormalities: A. Rhythm
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
- UMLS CUI-3
- C0199556
Description
Sinus bradycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (heart rate 40-50 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (heart rate 30-39 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (heart rate < 30 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus pause
Data type
boolean
Alias
- UMLS CUI [1]
- C1955864
Description
Sinus tachycardia (heart rate >100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0039239
Description
Ectopic supraventricular beats
Data type
boolean
Alias
- UMLS CUI [1]
- C0033036
Description
Ectopic supraventricular rhythm
Data type
boolean
Alias
- UMLS CUI [1]
- C2348376
Description
Wandering atrial pacemaker
Data type
boolean
Alias
- UMLS CUI [1]
- C1321523
Description
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0221158
Description
Supraventricular tachycardia (heart rate >100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0039240
Description
Atrial flutter
Data type
boolean
Alias
- UMLS CUI [1]
- C0004239
Description
Atrial Fibrillation
Data type
boolean
Alias
- UMLS CUI [1]
- C0004238
Description
Junctional rhythm (heart rate ≤100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0232208
Description
Junctional rhythm
Data type
boolean
Alias
- UMLS CUI [1]
- C0232208
Description
Junctional tachycardia (heart rate > 100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0039235
Description
Ectopic ventricular beats
Data type
boolean
Alias
- UMLS CUI [1]
- C0151636
Description
Ventricular couplets
Data type
boolean
Alias
- UMLS CUI [1]
- C0429001
Description
Bigeminy
Data type
boolean
Alias
- UMLS CUI [1]
- C0262662
Description
Trigeminy
Data type
boolean
Alias
- UMLS CUI [1]
- C0428999
Description
Electrical alternans
Data type
boolean
Alias
- UMLS CUI [1]
- C1142551
Description
R on T phenomenon
Data type
boolean
Alias
- UMLS CUI [1]
- C0877658
Description
Ventricular Fibrillation
Data type
boolean
Alias
- UMLS CUI [1]
- C0042510
Description
Idioventricular rhythm (heart rate < 100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0700363
Description
Sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0750197
Description
Non-sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0750194
Description
Wide QRS Tachycardia (diagnosis unknown)
Data type
boolean
Alias
- UMLS CUI [1]
- C0344429
Description
Ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0042514
Description
Monomorphic ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0344431
Description
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Data type
boolean
Alias
- UMLS CUI [1]
- C0040479
Description
Polymorphic (sustained and non-sustained) ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0344432
Description
Artificial pacemaker
Data type
boolean
Alias
- UMLS CUI [1]
- C0030163
Description
Other abnormal rhythm
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0199556
Description
Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0199556
- UMLS CUI [1,2]
- C0947611
Description
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
Description
Left atrial abnormality (P mitrale)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Description
Right atrial abnormality (P pulmonale)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Description
Right ventricular hypertrophy
Data type
boolean
Alias
- UMLS CUI [1]
- C0162770
Description
Intraatrial conduction delay
Data type
boolean
Alias
- UMLS CUI [1]
- C2346510
Description
Increased voltage consistent with left ventricular hypertrophy
Data type
boolean
Alias
- UMLS CUI [1]
- C1112650
Description
Other morphology
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0332437
Description
Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0429098
- UMLS CUI [1,3]
- C0429084
- UMLS CUI [1,4]
- C0947611
Description
12-Lead ECG Abnormalities: C. Conduction
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
- UMLS CUI-3
- C0232217
Description
First degree AV block (PR interval > 200 msec)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085614
Description
Short PR interval
Data type
boolean
Alias
- UMLS CUI [1]
- C0520878
Description
Second degree AV block (Mobitz type 1)
Data type
boolean
Alias
- UMLS CUI [1]
- C0264907
Description
Second degree AV block (Mobitz type 2)
Data type
boolean
Alias
- UMLS CUI [1]
- C0155700
Description
2:1 AV block
Data type
boolean
Alias
- UMLS CUI [1]
- C2346542
Description
Third degree AV block
Data type
boolean
Alias
- UMLS CUI [1]
- C0151517
Description
Left axis deviation (QRS axis more negative than -30°)
Data type
boolean
Alias
- UMLS CUI [1]
- C0232297
Description
Right axis deviation (QRS axis more positive than +110°)
Data type
boolean
Alias
- UMLS CUI [1]
- C0232296
Description
Incomplete right bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0262525
Description
Incomplete left bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0281878
Description
Right bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0085615
Description
Left anterior hemiblock (synonymous to left anterior fascicular block)
Data type
boolean
Alias
- UMLS CUI [1]
- C0264912
Description
Left posterior hemiblock (synonymous to left posterior fascicular block)
Data type
boolean
Alias
- UMLS CUI [1]
- C0264913
Description
Left Bundle Branch Block
Data type
boolean
Alias
- UMLS CUI [1]
- C0023211
Description
Bifascicular block
Data type
boolean
Alias
- UMLS CUI [1]
- C0264914
Description
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
Data type
boolean
Alias
- UMLS CUI [1]
- C3697597
Description
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0264897
- UMLS CUI [1,2]
- C0043202
Description
Prolonged QT interval
Data type
boolean
Alias
- UMLS CUI [1]
- C0151878
Description
QT/QTc prolongation ≥ 500 msec
Data type
boolean
Alias
- UMLS CUI [1]
- C0855333
Description
AV dissociation
Data type
boolean
Alias
- UMLS CUI [1]
- C0004331
Description
Other conduction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0522055
Description
Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0232217
- UMLS CUI [1,3]
- C0947611
Description
12-Lead ECG Abnormalities: D. Myocardial Infarction
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
- UMLS CUI-3
- C0027051
Description
Myocardial infarction, old
Data type
boolean
Alias
- UMLS CUI [1]
- C0155668
Description
Myocardial infarction, anterior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340293
Description
Myocardial infarction, lateral
Data type
boolean
Alias
- UMLS CUI [1]
- C0340312
Description
Myocardial infarction, posterior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340319
Description
Myocardial infarction, inferior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340305
Description
Myocardial infarction, septal
Data type
boolean
Alias
- UMLS CUI [1]
- C0746727
Description
Myocardial infarction, Non-Q wave
Data type
boolean
Alias
- UMLS CUI [1]
- C0542269
Description
Other myocardial infarction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0522055
Description
Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0947611
Description
12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0522055
- UMLS CUI-3
- C0948857
Description
Non-specific ST-T changes
Data type
boolean
Alias
- UMLS CUI [1]
- C1112720
Description
J point elevation
Data type
boolean
Alias
- UMLS CUI [1]
- C2346597
Description
ST elevation
Data type
boolean
Alias
- UMLS CUI [1]
- C0520886
Description
ST elevation-pericarditis
Data type
boolean
Alias
- UMLS CUI [1]
- C2348119
Description
ST depression
Data type
boolean
Alias
- UMLS CUI [1]
- C0520887
Description
ST segment abnormality, not specified
Data type
boolean
Alias
- UMLS CUI [1]
- C2348120
Description
U waves abnormal
Data type
boolean
Alias
- UMLS CUI [1]
- C0438169
Description
T wave inversion
Data type
boolean
Alias
- UMLS CUI [1]
- C0520888
Description
T wave peaked
Data type
boolean
Alias
- UMLS CUI [1]
- C0239242
Description
T waves flat
Data type
boolean
Alias
- UMLS CUI [1]
- C2215959
Description
T waves biphasic
Data type
boolean
Alias
- UMLS CUI [1]
- C2348639
Description
Notched T-waves
Data type
boolean
Alias
- UMLS CUI [1]
- C2347367
Description
Low QRS voltage
Data type
boolean
Alias
- UMLS CUI [1]
- C2349945
Description
T-wave flattening/inversion
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0520888
- UMLS CUI [1,2]
- C0429059
Description
T wave abnormality, not specified
Data type
boolean
Alias
- UMLS CUI [1]
- C0438167
Description
Other depolarisation/repolarisation
Data type
boolean
Alias
- UMLS CUI [1]
- C0948857
Description
Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0948857
- UMLS CUI [1,2]
- C0947611
Description
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])