ID

37504

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

Keywords

Versions (2)
  1. 7/27/19 7/27/19 -
  2. 8/4/19 8/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 4, 2019

DOI

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License

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

English

Logs / Repeats - Summary Holter; Summary Holter Abnormalities

1 forms  
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

Data type

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

Data type

datetime

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

Interpretation of Holter

Data type

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0438154
Summary Holter Abnormalities
Description

Summary Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C1704258
Start Date and Time of Holter
Description

Start Date and Time of Holter

Data type

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

Data type

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3899266
Record clinically significant Abnormalities
Description

Record clinically significant Abnormalities

Data type

text

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

Other abnormal Rhythm

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0199556
UMLS CUI [1,3]
C0205394
Other Morphology
Description

Other Morphology

Data type

text

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

Other Conduction

Data type

text

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

Other myocardial infarction

Data type

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
Other Depolarisation/ Repolarisation
Description

Other Depolarisation/ Repolarisation

Data type

text

Alias
UMLS CUI [1,1]
C1331539
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0948857
UMLS CUI [2,2]
C0205394
Other abnormality / Cardiologist comments
Description

Other abnormality / Cardiologist comments

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0175906
UMLS CUI [2,2]
C0947611
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Similar models

Logs / Repeats - Summary Holter; Summary Holter Abnormalities

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
Result of the ECG
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 (3)
CL Item
No result  (4)
CL Item
Unable to evaluate (8)
Item Group
Summary Holter Abnormalities
C0013801 (UMLS CUI-1)
C1704258 (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
Record clinically significant Abnormalities
text
C0013801 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
undefined item
Code List
Record clinically significant Abnormalities
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
Multifoca 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, 3-30 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
2: 1 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
Incomplete 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 (A57)
CL Item
ST depression (A58)
CL Item
ST segment abnormality (A59)
CL Item
U waves (A60)
CL Item
T wave inversion (A61)
CL Item
T wave peaked (A62)
CL Item
T waves biphasic (A63)
CL Item
T waves flat (A64)
CL Item
Notched T-waves (A65)
CL Item
Low QRS voltage (A66)
CL Item
T wave abnormality (A67)
CL Item
Other abnormal rhythm (A94)
CL Item
Other morphology (A95)
CL Item
Other conduction (A96)
CL Item
Other myocardial infarction (A97)
CL Item
Other depolarisation/ repolarisation (A98)
CL Item
Other abnormalities/ Cardiologist comments (A99)
Other abnormal Rhythm
Item
Other abnormal Rhythm
text
C1704258 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Other Morphology
Item
Other Morphology
text
C0332437 (UMLS CUI [1,1])
C0205394 (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
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other Depolarisation/ Repolarisation
Item
Other Depolarisation/ Repolarisation
text
C1331539 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Other abnormality / Cardiologist comments
Item
Other abnormality / Cardiologist comments
text
C1704258 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
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