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ID
31479
Description
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders
Keywords
Versions (3)
- 8/20/18 8/20/18 -
- 8/27/18 8/27/18 -
- 9/20/21 9/20/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 27, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384
Vital Signs and ECG - Screening
- StudyEvent: ODM
Similar models
Vital Signs and ECG - Screening
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Patient identification
Item
Subjects Identification
integer
C1269815 (UMLS CUI [1])
Time; Date in time
Item
Actual date/ time
datetime
C0040223 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
integer
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Respiratory rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Electrocardiogram Collection Date Time
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval feature (observable entity)
Item
Uncorrected QT Interval
float
C0429028 (UMLS CUI [1])
qtc interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0489625 (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)
Item Group
Summary Holter
C0013801 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
C0242482 (UMLS CUI-2)
Start Date and Time of Procedure; Holter Electrocardiography
Item
Start Date and Time of Holter
datetime
C3897500 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,2])
End date; End Time; Holter Electrocardiography
Item
Stop Date and Time of Holter
datetime
C0806020 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,3])
C1522314 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,3])
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 (3)
CL Item
No result (4)
CL Item
Unable to evaluate (8)
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 Procedure; Holter Electrocardiography
Item
Start Date and Time of Holter
datetime
C3897500 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,2])
End date; End Time; Holter Electrocardiography
Item
Stop Date and Time of Holter
datetime
C0806020 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,3])
C1522314 (UMLS CUI [1,2])
C0013801 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities below. Check all that apply.
text
C0013801 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,2])
Code List
Record clinically significant abnormalities below. Check all that apply.
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 rythm ([A08])
CL Item
Wandering atrial pacemaker ([A09])
CL Item
Multiocal 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 supraventriculartachycardia (>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 alterrans ([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 (> 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 >200 msec) ([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 degreees) ([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 interventricular conduction delay (QRS > = 120 msec) ([A49])
CL Item
Accessory pathway (Wollf- 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 abnormality/ Cardiologist comments ([A99])
heart; rhythm abnormal (symptom); Other; Specification
Item
If other abnormal heart rhythm, please specify.
text
C1533266 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Electrocardiography; Morphology; Other; Specification
Item
If other ecg morphology, please specify.
text
C1623258 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0332437 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Abnormal cardiac conduction; Other; Specification
Item
If other cardiac conduction, please specify.
text
C0232219 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Myocardial Infarction; Other; Specification
Item
If other myocardial infarction, please specify.
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Electrocardiogram repolarisation abnormality; Other; Specification
Item
If other cardiac depolarisation/ repolarisation, please specify.
text
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
ECG abnormality; Other; Specification | Cardiologists; Comment
Item
If other ecg abnormality, please specify / Cardiologist comments
text
C1832603 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])