ID

30521

Beskrivning

This ODM file contains the 12-Lead ECG Abnormalities Form. To be filled for each ECG with abnormalities during the study. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Länk

https://clinicaltrials.gov/ct2/show/NCT01039454

Nyckelord

D001067

Clinical Trial

Electrocardiogram (ECG)

D009765

2018-06-11 2018-06-11 - Sarah Riepenhausen

Rättsinnehavare

GlaxoSmithKline

Uppladdad den

11 juni 2018

DOI

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Licens

Creative Commons BY-NC 3.0

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Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

model
Detaljer

ECG Abnormalities

1 Formulär

StudyEvent: ODM
1. ECG Abnormalities

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

12-lead ECG Abnormalities

Item Group

12-lead ECG Abnormalities

C0430456 (UMLS CUI-1)
C0522055 (UMLS CUI-2)

Start Date of ECG

Item

Start Date of ECG

date

C0430456 (UMLS CUI [1,1])
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])

ECG Number

Item

ECG Number

text

C1623258 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

Subject Identifier

Item

Subject Identifier

text

C2348585 (UMLS CUI [1])

12-Lead ECG Abnormalities: A. Rhythm

Item Group

12-Lead ECG Abnormalities: A. Rhythm

C0430456 (UMLS CUI-1)
C1704258 (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])

Sinus Arrhythmia

Item

Sinus Arrhythmia

boolean

C0003813 (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

C1533266 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

Comment

Item

Comment

text

C0947611 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])

12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology

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)

Left atrial abnormality (P mitrale)

Item

Left atrial abnormality (P mitrale)

boolean

C0344711 (UMLS CUI [1,1])
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])

Right ventricular hypertrophy

Item

Right ventricular hypertrophy

boolean

C0162770 (UMLS CUI [1])

Intraatrial conduction delay

Item

Intraatrial conduction delay

boolean

C2346510 (UMLS CUI [1])

Poor R wave progression

Item

Poor R wave progression

boolean

C0877038 (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])

Comment

Item

Comment

text

C0522055 (UMLS CUI [1,1])
C0429098 (UMLS CUI [1,2])
C0429084 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])

12-Lead ECG Abnormalities: C. Conduction

Item Group

12-Lead ECG Abnormalities: C. Conduction

C0430456 (UMLS CUI-1)
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])

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])

Comment

Item

Comment

text

C0522055 (UMLS CUI [1,1])
C0232217 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])

12-Lead ECG Abnormalities: D. Myocardial Infarction

Item Group

12-Lead ECG Abnormalities: D. Myocardial Infarction

C0430456 (UMLS CUI-1)
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])

Junvenile T-wave pattern, early repolarization

Item

Junvenile T-wave pattern, early repolarization

boolean

C0520888 (UMLS CUI [1])

Other myocardial infarction

Item

Other myocardial infarction

boolean

C0027051 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])

Comment

Item

Comment

text

C0027051 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])

12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T)

Item Group

12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T)

C0430456 (UMLS CUI-1)
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])

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])

12-Lead ECG Abnormalities: Other Abnormalities

Item Group

12-Lead ECG Abnormalities: Other Abnormalities

C0430456 (UMLS CUI-1)
C0522055 (UMLS CUI-2)

Other abnormalities

Item

Other abnormalities

boolean

C0430456 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])

Comment

Item

Comment

text

C0430456 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])

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Länk

Nyckelord

Versioner (1)

Rättsinnehavare

Uppladdad den

DOI

Licens

Modellkommentarer :

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Item-kommentar för :

Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

ECG Abnormalities

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