ID

37661

Description

Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Mots-clés

Versions (5)
  1. 23/06/2019 23/06/2019 -
  2. 04/08/2019 04/08/2019 -
  3. 14/08/2019 14/08/2019 -
  4. 14/08/2019 14/08/2019 -
  5. 20/09/2021 20/09/2021 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

14 août 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957

Anglais

Screening - 12-Lead ECG; Subject Identification; Summary Holter; Summary Holter Abnormalities

1 Formulaires  
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date and Time of ECG
Description

Date and Time of ECG

Type de données

datetime

Alias
UMLS CUI [1]
C2826846
12-Lead ECG - Hart rate
Description

12-Lead ECG - Hart rate

Type de données

integer

Unités de mesure
  • beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
beats/min
PR Intreval
Description

PR Intreval

Type de données

integer

Unités de mesure
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Description

QRS Duration

Type de données

integer

Unités de mesure
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Type de données

integer

Unités de mesure
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Description

QTc Interval

Type de données

integer

Unités de mesure
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Method of QTc Calculation
Description

Method of QTc Calculation

Type de données

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Description

Result of the ECG

Type de données

integer

Alias
UMLS CUI [1]
C0438154
Subject Identification
Description

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject number
Description

Subject number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Summary Holter
Description

Summary Holter

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0242482
Start Date and Time of Holter
Description

Start Date and Time of Holter

Type de données

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3897500
Stop Date and Time of Holter
Description

Stop Date and Time of Holter

Type de données

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3899266
Interpretation of Holter
Description

Interpretation of Holter

Type de données

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0438154
Holter monitoring method
Description

Holter monitoring method

Type de données

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0871511
Summary Holter Abnormalities
Description

Summary Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0522055
UMLS CUI-3
C0242482
Start Date and Time of Holter
Description

Start Date and Time of Holter

Type de données

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3897500
Stop Date and Time of Holter
Description

Stop Date and Time of Holter

Type de données

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3899266
Holter Abnormalities
Description

Check all that apply

Type de données

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0522055
Other abnormal rhythm
Description

Other abnormal rhythm

Type de données

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0199556
UMLS CUI [1,3]
C0205161
Other morphology
Description

Other morphology

Type de données

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0332437
Other conduction
Description

Other conduction

Type de données

text

Alias
UMLS CUI [1,1]
C0232217
UMLS CUI [1,2]
C0205394
Other myocardial infarction
Description

Other myocardial infarction

Type de données

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0027051
Other depolarisation/repolarisation
Description

Other depolarisation/repolarisation

Type de données

text

Alias
UMLS CUI [1,1]
C0948857
UMLS CUI [1,2]
C0205394
Other abnormality/ Cardiologist comments
Description

Other abnormality/ Cardiologist comments

Type de données

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1832603
UMLS CUI [2]
C0947611
Retour au début de la page

Similar models

Screening - 12-Lead ECG; Subject Identification; Summary Holter; Summary Holter Abnormalities

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
12-Lead ECG - Hart rate
Item
12-Lead ECG - Hart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
PR Intreval
Item
PR Intreval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Subject Identification
C2348585 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Summary Holter
C0013801 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
Start Date and Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
Stop Date and Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3899266 (UMLS CUI [1,2])
Item
Interpretation of Holter
integer
C0013801 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])
Interpretation of Holter
Code List
Interpretation of Holter
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the Holter abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (4)
CL Item
Unable to evaluate (8)
Item
Holter monitoring method
integer
C0013801 (UMLS CUI [1,1])
C0871511 (UMLS CUI [1,2])
Holter monitoring method
Code List
Holter monitoring method
CL Item
12 Lead 1000Hz (1)
CL Item
12 Lead 180Hz (2)
CL Item
3 Lead 180Hz (3)
CL Item
5 Lead 512Hz (5)
Item Group
Summary Holter Abnormalities
C0013801 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
C0242482 (UMLS CUI-3)
Start Date and Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
Stop Date and Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3899266 (UMLS CUI [1,2])
Item
Holter Abnormalities
text
C0013801 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
Holter Abnormalities
Code List
Holter Abnormalities
CL Item
No abnormalities (A00)
CL Item
Sinus bradycardia (50-59 beats/min) (A01)
CL Item
Sinus bradycardia (40-49 beats/min) (A02)
CL Item
Sinus bradycardia (30-39 beats/min) (A03)
CL Item
Sinus bradycardia (<30 beats/min) (A04)
CL Item
Sinus pause (A05)
CL Item
Sinus tachycardia (>100 beats/min) (A06)
CL Item
Ectopic supraventricular beats (A07)
CL Item
Ectopic supraventricular rhythm (A08)
CL Item
Wandering atrial pacemaker (A09)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (A10)
CL Item
Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (A11)
CL Item
Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (A12)
CL Item
Atrial flutter (A13)
CL Item
Atrial fibrillation (A14)
CL Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (A15)
CL Item
Junctional tachycardia (>100 beats/min) (A16)
CL Item
Ventricular premature depolarisation (A17)
CL Item
Ventricular couplets (A18)
CL Item
Bigeminy (A19)
CL Item
Trigeminy (A20)
CL Item
Electrical alternans (A21)
CL Item
R on T phenomenon (A22)
CL Item
Ventricular fibrillation (A23)
CL Item
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex) (A24)
CL Item
Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A25)
CL Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats) (A26)
CL Item
Wide QRS tachycardia (diagnosis unknown) (A27)
CL Item
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A28)
CL Item
Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (A29)
CL Item
Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A30)
CL Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (A31)
CL Item
Torsade de Pointes (TdP) (A32)
CL Item
Pacemaker (A33)
CL Item
First degree AV block (PR interval >200msec) (A34)
CL Item
Short PR Interval (A35)
CL Item
Second degree AV block (Mobitz type 1) (A36)
CL Item
Second degree AV block (Mobitz type 2) (A37)
CL Item
AV block (A38)
CL Item
Third degree AV block (A39)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (A40)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (A41)
CL Item
complete right bundle branch block (A42)
CL Item
Incomplete left bundle branch block (A43)
CL Item
Right bundle branch block (A44)
CL Item
Left anterior hemiblock (A45)
CL Item
Left posterior hemiblock (A46)
CL Item
Left bundle branch block (A47)
CL Item
Bifascicular block (A48)
CL Item
Non-specific intraventricular conduction delay (QRS >=120 msec) (A49)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine) (A50)
CL Item
QTc prolongation >=500 msec (A51)
CL Item
AV dissociation (A52)
CL Item
Myocardial infarction, old (A53)
CL Item
Myocardial infarction, non Q-wave (A54)
CL Item
Non-specific ST-T changes (A55)
CL Item
J point elevation (A56)
CL Item
ST elevation (A66)
CL Item
ST depression (A67)
CL Item
ST segment abnormality (A68)
CL Item
U waves (A69)
CL Item
T wave inversion (A70)
CL Item
T wave peaked (A71)
CL Item
T waves biphasic (A72)
CL Item
T waves flat (A73)
CL Item
Notched T-waves (A74)
CL Item
Low QRS voltage (A75)
CL Item
T wave abnormality (A76)
Other abnormal rhythm
Item
Other abnormal rhythm
text
C0205394 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Other morphology
Item
Other morphology
text
C0205394 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
Other conduction
Item
Other conduction
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other myocardial infarction
Item
Other myocardial infarction
text
C0205394 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
Other depolarisation/repolarisation
Item
Other depolarisation/repolarisation
text
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other abnormality/ Cardiologist comments
Item
Other abnormality/ Cardiologist comments
text
C0205394 (UMLS CUI [1,1])
C1832603 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
Retour au début de la page 

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