Informações:
Falhas:
ID
30156
Descrição
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
Palavras-chave
Versões (1)
- 16/05/2018 16/05/2018 -
Titular dos direitos
GlaxoSmithKline
Transferido a
16 de maio de 2018
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC 3.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061
12-lead ECG Abnormalities
- StudyEvent: ODM
Similar models
12-lead ECG Abnormalities
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
12-lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
C0522055 (UMLS CUI-2)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Result of the ECG
Item
Result of the ECG: Clinically significant abnormalities? Record clinically significant abnormalities (check all that apply)
boolean
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities: A. Rhythm
C0430456 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
C0199556 (UMLS CUI-3)
C0522055 (UMLS CUI-2)
C0199556 (UMLS CUI-3)
Sinus bradycardia
Item
Sinus bradycardia
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (heart rate 40-50 beats/min)
Item
Sinus bradycardia (heart rate 40-50 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (heart rate 30-39 beats/min)
Item
Sinus bradycardia (heart rate 30-39 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (heart rate < 30 beats/min)
Item
Sinus bradycardia (heart rate < 30 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus pause
Item
Sinus pause
boolean
C1955864 (UMLS CUI [1])
Sinus tachycardia (heart rate >100 beats/min)
Item
Sinus tachycardia (heart rate >100 beats/min)
boolean
C0039239 (UMLS CUI [1])
Ectopic supraventricular beats
Item
Ectopic supraventricular beats
boolean
C0033036 (UMLS CUI [1])
Ectopic supraventricular rhythm
Item
Ectopic supraventricular rhythm
boolean
C2348376 (UMLS CUI [1])
Wandering atrial pacemaker
Item
Wandering atrial pacemaker
boolean
C1321523 (UMLS CUI [1])
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
boolean
C0221158 (UMLS CUI [1])
Supraventricular tachycardia (heart rate >100 beats/min)
Item
Supraventricular tachycardia (heart rate >100 beats/min)
boolean
C0039240 (UMLS CUI [1])
Atrial flutter
Item
Atrial flutter
boolean
C0004239 (UMLS CUI [1])
Atrial Fibrillation
Item
Atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Junctional rhythm (heart rate ≤100 beats/min)
Item
Junctional rhythm (heart rate ≤100 beats/min)
boolean
C0232208 (UMLS CUI [1])
Junctional rhythm
Item
Junctional rhythm
boolean
C0232208 (UMLS CUI [1])
Junctional tachycardia (heart rate > 100 beats/min)
Item
Junctional tachycardia (heart rate > 100 beats/min)
boolean
C0039235 (UMLS CUI [1])
Ectopic ventricular beats
Item
Ectopic ventricular beats
boolean
C0151636 (UMLS CUI [1])
Ventricular couplets
Item
Ventricular couplets
boolean
C0429001 (UMLS CUI [1])
Bigeminy
Item
Bigeminy
boolean
C0262662 (UMLS CUI [1])
Trigeminy
Item
Trigeminy
boolean
C0428999 (UMLS CUI [1])
Electrical alternans
Item
Electrical alternans
boolean
C1142551 (UMLS CUI [1])
R on T phenomenon
Item
R on T phenomenon
boolean
C0877658 (UMLS CUI [1])
Ventricular Fibrillation
Item
Ventricular fibrillation
boolean
C0042510 (UMLS CUI [1])
Idioventricular rhythm (heart rate < 100 beats/min)
Item
Idioventricular rhythm (heart rate < 100 beats/min)
boolean
C0700363 (UMLS CUI [1])
Sustained ventricular tachycardia
Item
Sustained ventricular tachycardia
boolean
C0750197 (UMLS CUI [1])
Non-sustained ventricular tachycardia
Item
Non-sustained ventricular tachycardia
boolean
C0750194 (UMLS CUI [1])
Wide QRS Tachycardia (diagnosis unknown)
Item
Wide QRS Tachycardia (diagnosis unknown)
boolean
C0344429 (UMLS CUI [1])
Ventricular tachycardia
Item
Ventricular tachycardia
boolean
C0042514 (UMLS CUI [1])
Monomorphic ventricular tachycardia
Item
Monomorphic ventricular tachycardia
boolean
C0344431 (UMLS CUI [1])
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
boolean
C0040479 (UMLS CUI [1])
Polymorphic (sustained and non-sustained) ventricular tachycardia
Item
Polymorphic (sustained and non-sustained) ventricular tachycardia
boolean
C0344432 (UMLS CUI [1])
Artificial pacemaker
Item
Artificial pacemaker
boolean
C0030163 (UMLS CUI [1])
Other abnormal rhythm
Item
Other abnormal rhythm
boolean
C0522055 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0199556 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology
C0430456 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
C0429098 (UMLS CUI-3)
C0429084 (UMLS CUI-4)
C0522055 (UMLS CUI-2)
C0429098 (UMLS CUI-3)
C0429084 (UMLS CUI-4)
Left atrial abnormality (P mitrale)
Item
Left atrial abnormality (P mitrale)
boolean
C0344711 (UMLS CUI [1,1])
C0232310 (UMLS CUI [1,2])
C0232310 (UMLS CUI [1,2])
Right atrial abnormality (P pulmonale)
Item
Right atrial abnormality (P pulmonale)
boolean
C0344696 (UMLS CUI [1,1])
C0232308 (UMLS CUI [1,2])
C0232308 (UMLS CUI [1,2])
Right ventricular hypertrophy
Item
Right ventricular hypertrophy
boolean
C0162770 (UMLS CUI [1])
Intraatrial conduction delay
Item
Intraatrial conduction delay
boolean
C2346510 (UMLS CUI [1])
Increased voltage consistent with left ventricular hypertrophy
Item
Increased voltage consistent with left ventricular hypertrophy
boolean
C1112650 (UMLS CUI [1])
Other morphology
Item
Other morphology
boolean
C0522055 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0522055 (UMLS CUI [1,1])
C0429098 (UMLS CUI [1,2])
C0429084 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0429098 (UMLS CUI [1,2])
C0429084 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Item Group
12-Lead ECG Abnormalities: C. Conduction
C0430456 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
C0232217 (UMLS CUI-3)
C0522055 (UMLS CUI-2)
C0232217 (UMLS CUI-3)
First degree AV block (PR interval > 200 msec)
Item
First degree AV block (PR interval > 200 msec)
boolean
C0085614 (UMLS CUI [1])
Short PR interval
Item
Short PR interval
boolean
C0520878 (UMLS CUI [1])
Second degree AV block (Mobitz type 1)
Item
Second degree AV block (Mobitz type 1)
boolean
C0264907 (UMLS CUI [1])
Second degree AV block (Mobitz type 2)
Item
Second degree AV block (Mobitz type 2)
boolean
C0155700 (UMLS CUI [1])
2:1 AV block
Item
2:1 AV block
boolean
C2346542 (UMLS CUI [1])
Third degree AV block
Item
Third degree AV block
boolean
C0151517 (UMLS CUI [1])
Left axis deviation (QRS axis more negative than -30°)
Item
Left axis deviation (QRS axis more negative than -30°) than -30°)
boolean
C0232297 (UMLS CUI [1])
Right axis deviation (QRS axis more positive than +110°)
Item
Right axis deviation (QRS axis more positive than +110°)
boolean
C0232296 (UMLS CUI [1])
Incomplete right bundle branch block
Item
Incomplete right bundle branch block
boolean
C0262525 (UMLS CUI [1])
Incomplete left bundle branch block
Item
Incomplete left bundle branch block
boolean
C0281878 (UMLS CUI [1])
Right bundle branch block
Item
Right bundle branch block
boolean
C0085615 (UMLS CUI [1])
Left anterior hemiblock (synonymous to left anterior fascicular block)
Item
Left anterior hemiblock (synonymous to left anterior fascicular block)
boolean
C0264912 (UMLS CUI [1])
Left posterior hemiblock (synonymous to left posterior fascicular block)
Item
Left posterior hemiblock (synonymous to left posterior fascicular block)
boolean
C0264913 (UMLS CUI [1])
Left Bundle Branch Block
Item
Left Bundle Branch Block
boolean
C0023211 (UMLS CUI [1])
Bifascicular block
Item
Bifascicular block
boolean
C0264914 (UMLS CUI [1])
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
Item
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
boolean
C3697597 (UMLS CUI [1])
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
boolean
C0264897 (UMLS CUI [1,1])
C0043202 (UMLS CUI [1,2])
C0043202 (UMLS CUI [1,2])
Prolonged QT interval
Item
Prolonged QT interval
boolean
C0151878 (UMLS CUI [1])
QT/QTc prolongation ≥ 500 msec
Item
QT/QTc prolongation ≥ 500 msec
boolean
C0855333 (UMLS CUI [1])
AV dissociation
Item
AV dissociation
boolean
C0004331 (UMLS CUI [1])
Other conduction
Item
Other conduction
boolean
C0232217 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0522055 (UMLS CUI [1,1])
C0232217 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0232217 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
12-Lead ECG Abnormalities: D. Myocardial Infarction
C0430456 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
C0027051 (UMLS CUI-3)
C0522055 (UMLS CUI-2)
C0027051 (UMLS CUI-3)
Myocardial infarction, old
Item
Myocardial infarction, old
boolean
C0155668 (UMLS CUI [1])
Myocardial infarction, anterior
Item
Myocardial infarction, anterior
boolean
C0340293 (UMLS CUI [1])
Myocardial infarction, lateral
Item
Myocardial infarction, lateral
boolean
C0340312 (UMLS CUI [1])
Myocardial infarction, posterior
Item
Myocardial infarction, posterior
boolean
C0340319 (UMLS CUI [1])
Myocardial infarction, inferior
Item
Myocardial infarction, inferior
boolean
C0340305 (UMLS CUI [1])
Myocardial infarction, septal
Item
Myocardial infarction, septal
boolean
C0746727 (UMLS CUI [1])
Myocardial infarction, Non-Q wave
Item
Myocardial infarction, Non-Q wave
boolean
C0542269 (UMLS CUI [1])
Other myocardial infarction
Item
Other myocardial infarction
boolean
C0027051 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0027051 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T)
C0430456 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
C0948857 (UMLS CUI-3)
C0522055 (UMLS CUI-2)
C0948857 (UMLS CUI-3)
Non-specific ST-T changes
Item
Non-specific ST-T changes
boolean
C1112720 (UMLS CUI [1])
J point elevation
Item
J point elevation
boolean
C2346597 (UMLS CUI [1])
ST elevation
Item
ST elevation
boolean
C0520886 (UMLS CUI [1])
ST elevation-pericarditis
Item
ST elevation-pericarditis
boolean
C2348119 (UMLS CUI [1])
ST depression
Item
ST depression
boolean
C0520887 (UMLS CUI [1])
ST segment abnormality, not specified
Item
ST segment abnormality, not specified
boolean
C2348120 (UMLS CUI [1])
U waves abnormal
Item
U waves abnormal
boolean
C0438169 (UMLS CUI [1])
T wave inversion
Item
T wave inversion
boolean
C0520888 (UMLS CUI [1])
T wave peaked
Item
T wave peaked
boolean
C0239242 (UMLS CUI [1])
T waves flat
Item
T waves flat
boolean
C2215959 (UMLS CUI [1])
T waves biphasic
Item
T waves biphasic
boolean
C2348639 (UMLS CUI [1])
Notched T-waves
Item
Notched T-waves
boolean
C2347367 (UMLS CUI [1])
Low QRS voltage
Item
Low QRS voltage
boolean
C2349945 (UMLS CUI [1])
T-wave flattening/inversion
Item
T-wave flattening/inversion
boolean
C0520888 (UMLS CUI [1,1])
C0429059 (UMLS CUI [1,2])
C0429059 (UMLS CUI [1,2])
T wave abnormality, not specified
Item
T wave abnormality, not specified
boolean
C0438167 (UMLS CUI [1])
Other depolarisation/repolarisation
Item
Other depolarisation/repolarisation
boolean
C0948857 (UMLS CUI [1])
Comment
Item
Comment
text
C0948857 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities: Other Abnormalities
C0430456 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
C0522055 (UMLS CUI-2)
Other abnormalities
Item
Other abnormalities
boolean
C0430456 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0430456 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0522055 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])