ID
30157
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: Repeat Holter ECG
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
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061
Repeat Holter ECG
- StudyEvent: ODM
Description
Repeat Holter ECG Abnormalities
Alias
- UMLS CUI-1
- C0013801
- UMLS CUI-2
- C0522055
Description
Holter ECG Abnormalities
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0522055
Description
Start Date Holter ECG
Data type
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0808070
Description
Start Time Holter ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1301880
Description
Stop Date Holter ECG
Data type
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0806020
Description
Stop Time Holter ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1522314
Description
Sinus bradycardia (50-59 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (40-49 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (30-39 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (<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 (>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
Data type
boolean
Alias
- UMLS CUI [1]
- C0221158
Description
Non-sustained supra ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0750194
Description
Sustained supraventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0443318
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
Data type
boolean
Alias
- UMLS CUI [1]
- C0232208
Description
Junctional tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0039235
Description
Ventricular premature depolarisation
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
Data type
boolean
Alias
- UMLS CUI [1]
- C0700363
Description
Non-sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0750194
Description
Sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0750197
Description
Wide QRS tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0344429
Description
Monomorphic non-sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750194
Description
Monomorphic sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750197
Description
Polymorphic non-sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750194
Description
Polymorphic sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
Description
Torsade de Pointes (TdP)
Data type
boolean
Alias
- UMLS CUI [1]
- C0040479
Description
Pacemaker
Data type
boolean
Alias
- UMLS CUI [1]
- C0030163
Description
First degree AV block
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 I)
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
Data type
boolean
Alias
- UMLS CUI [1]
- C0232297
Description
Right axis deviation
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
Data type
boolean
Alias
- UMLS CUI [1]
- C0264912
Description
Left posterior hemiblock
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
Data type
boolean
Alias
- UMLS CUI [1]
- C3697597
Description
Accessory pathway
Data type
boolean
Alias
- UMLS CUI [1]
- C1963785
Description
QTc prolongation >=500 msec
Data type
boolean
Alias
- UMLS CUI [1]
- C1969409
Description
AV dissociation
Data type
boolean
Alias
- UMLS CUI [1]
- C0004331
Description
Myocardial infarction, old
Data type
boolean
Alias
- UMLS CUI [1]
- C0155668
Description
Myocardial infarction, non Q-wave
Data type
boolean
Alias
- UMLS CUI [1]
- C0542269
Description
Non-specific ST-T changes
Data type
boolean
Alias
- UMLS CUI [1]
- C1112720
Description
J point devation
Data type
boolean
Alias
- UMLS CUI [1]
- C2346597
Description
ST elevation
Data type
boolean
Alias
- UMLS CUI [1]
- C0520886
Description
ST depression
Data type
boolean
Alias
- UMLS CUI [1]
- C0520887
Description
ST segment abnormality
Data type
boolean
Alias
- UMLS CUI [1]
- C2348120
Description
U waves
Data type
boolean
Alias
- UMLS CUI [1]
- C0232333
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 biphasic
Data type
boolean
Alias
- UMLS CUI [1]
- C2348639
Description
T waves flat
Data type
boolean
Alias
- UMLS CUI [1]
- C2215959
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 abnomality
Data type
boolean
Alias
- UMLS CUI [1]
- C0438167
Description
morphology
Data type
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0013801
Description
abnormal rhythm
Data type
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0013801
Description
conduction
Data type
text
Alias
- UMLS CUI [1,1]
- C0232219
- UMLS CUI [1,2]
- C0013801
Description
myocardial infarction
Data type
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0013801
Description
depolarisation/repolarisation
Data type
text
Alias
- UMLS CUI [1,1]
- C0948857
- UMLS CUI [1,2]
- C0013801
Description
Other abnormality Holter ECG
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0013801
Similar models
Repeat Holter ECG
- StudyEvent: ODM
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0438154 (UMLS CUI [1,2])
C0522055 (UMLS CUI-2)
C0522055 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0750194 (UMLS CUI [1,2])
C0443318 (UMLS CUI [1,2])
C0750194 (UMLS CUI [1,2])
C0750197 (UMLS CUI [1,2])
C0750194 (UMLS CUI [1,2])
C0750197 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,2])