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Information:
Fel:
ID
36949
Beskrivning
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
Nyckelord
Versioner (5)
- 2019-06-23 2019-06-23 -
- 2019-08-04 2019-08-04 -
- 2019-08-14 2019-08-14 -
- 2019-08-14 2019-08-14 -
- 2021-09-20 2021-09-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
23 juni 2019
DOI
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Licens
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
Screening - 12-Lead ECG; Eligibility question; Subject Identification; Summary Holter; Summary Holter Abnormalities
Similar models
Screening - 12-Lead ECG; Eligibility question; Subject Identification; Summary Holter; Summary Holter Abnormalities
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (2)
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)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item
Violations of any Inclusion criteria
text
C1512693 (UMLS CUI [1,1])
C1709750 (UMLS CUI [1,2])
C1709750 (UMLS CUI [1,2])
CL Item
Inclusion Criteria 1 (I01)
CL Item
Inclusion Criteria 2 (I02)
CL Item
Inclusion Criteria 3 (I03)
CL Item
Inclusion Criteria 4 (I04)
CL Item
Inclusion Criteria 5 (I05)
CL Item
Inclusion Criteria 6 (I06)
CL Item
Inclusion Criteria 7 (I07)
CL Item
Inclusion Criteria 8 (I08)
CL Item
Inclusion Criteria 9 (I09)
CL Item
Inclusion Criteria 10 (I10)
Item
Violations of any Exclusion criteria
text
C0680251 (UMLS CUI [1,1])
C1709750 (UMLS CUI [1,2])
C1709750 (UMLS CUI [1,2])
CL Item
Exclusion Criteria 1 (E01)
CL Item
Exclusion Criteria 2 (E02)
CL Item
Exclusion Criteria 3 (E03)
CL Item
Exclusion Criteria 4 (E04)
CL Item
Exclusion Criteria 5 (E05)
CL Item
Exclusion Criteria 6 (E06)
CL Item
Exclusion Criteria 7 (E07)
CL Item
Exclusion Criteria 8 (E08)
CL Item
Exclusion Criteria 9 (E09)
CL Item
Exclusion Criteria 10 (E10)
CL Item
Exclusion Criteria 11 (E11)
CL Item
Exclusion Criteria 12 (E12)
CL Item
Exclusion Criteria 13 (E13)
CL Item
Exclusion Criteria 14 (E14)
CL Item
Exclusion Criteria 15 (E15)
CL Item
Exclusion Criteria 16 (E16)
CL Item
Exclusion Criteria 17 (E17)
CL Item
Exc|usion Criteria 18 (E18)
CL Item
Exclusion Criteria 19 (E19)
CL Item
Exclusion Criteria 20 (E20)
CL Item
Exclusion Criteria 21 (E21)
CL Item
Exclusion Criteria 22 (E22)
CL Item
Exclusion Criteria 23 (E23)
CL Item
Exclusion Criteria 24 (E24)
CL Item
Exclusion Criteria 25 (E25)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Start Date and Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
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])
C3899266 (UMLS CUI [1,2])
Item
Interpretation of Holter
integer
C0013801 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])
C0438154 (UMLS CUI [1,2])
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])
C0871511 (UMLS CUI [1,2])
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)
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])
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])
C3899266 (UMLS CUI [1,2])
Item
Holter Abnormalities
text
C0013801 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,2])
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])
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])
C0332437 (UMLS CUI [1,2])
Other conduction
Item
Other conduction
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Other myocardial infarction
Item
Other myocardial infarction
text
C0205394 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,2])
Other depolarisation/repolarisation
Item
Other depolarisation/repolarisation
text
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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])
C1832603 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])