ID

44411

Beschrijving

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

Trefwoorden

Versies (3)
  1. 20-08-18 20-08-18 -
  2. 27-08-18 27-08-18 -
  3. 20-09-21 20-09-21 -
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GlaxoSmithKline

Geüploaded op

20 september 2021

DOI

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Creative Commons BY-NC 3.0
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Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384

Engels

Vital Signs and ECG - Screening

1 Formulieren  
Subjects Identification
Beschrijving

Subjects Identification

Alias
UMLS CUI-1
C1269815
Subjects Identification
Beschrijving

Patient identification

Datatype

integer

Alias
UMLS CUI [1]
C1269815
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/ time
Beschrijving

Time; Date in time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0011008
Height
Beschrijving

Body Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

Body Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beschrijving

Body mass index

Datatype

float

Alias
UMLS CUI [1]
C1305855
Blood pressure (systolic/ diastolic)
Beschrijving

Blood Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Beschrijving

heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Beschrijving

Respiratory rate

Datatype

integer

Maateenheden
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
12- Lead ECG
Beschrijving

12- Lead ECG

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

Electrocardiogram Collection Date Time

Datatype

datetime

Alias
UMLS CUI [1]
C2826846
Heart rate
Beschrijving

heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beschrijving

Electrocardiogram: P-R interval

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beschrijving

QRS complex duration (observable entity)

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beschrijving

QT interval feature (observable entity)

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429028
msec
QTc Interval
Beschrijving

qtc interval

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Method of QTc Calculation
Beschrijving

qtc interval; Evaluation Method

Datatype

integer

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C2911685
Result of the ECG
Beschrijving

EKG finding

Datatype

integer

Alias
UMLS CUI [1]
C0438154
Summary Holter
Beschrijving

Summary Holter

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

Start Date and Time of Procedure; Holter Electrocardiography

Datatype

datetime

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

End date; End Time; Holter Electrocardiography

Datatype

datetime

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1522314
UMLS CUI [1,3]
C0013801
Interpretation of Holter
Beschrijving

Holter Electrocardiography; Electrocardiogram finding

Datatype

integer

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

Summary Holter Abnormalities

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

Start Date and Time of Procedure; Holter Electrocardiography

Datatype

datetime

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

End date; End Time; Holter Electrocardiography

Datatype

datetime

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1522314
UMLS CUI [1,3]
C0013801
Record clinically significant abnormalities below. Check all that apply.
Beschrijving

Holter Electrocardiography; Electrocardiogram abnormal

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0522055
If other abnormal heart rhythm, please specify.
Beschrijving

heart; rhythm abnormal (symptom); Other; Specification

Datatype

text

Alias
UMLS CUI [1,1]
C1533266
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
If other ecg morphology, please specify.
Beschrijving

Electrocardiography; Morphology; Other; Specification

Datatype

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0332437
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
If other cardiac conduction, please specify.
Beschrijving

Abnormal cardiac conduction; Other; Specification

Datatype

text

Alias
UMLS CUI [1,1]
C0232219
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
If other myocardial infarction, please specify.
Beschrijving

Myocardial Infarction; Other; Specification

Datatype

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
If other cardiac depolarisation/ repolarisation, please specify.
Beschrijving

Electrocardiogram repolarisation abnormality; Other; Specification

Datatype

text

Alias
UMLS CUI [1,1]
C0948857
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
If other ecg abnormality, please specify / Cardiologist comments
Beschrijving

ECG abnormality; Other; Specification | Cardiologists; Comment

Datatype

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
UMLS CUI [2,1]
C0175906
UMLS CUI [2,2]
C0947611
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Similar models

Vital Signs and ECG - Screening

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Subjects Identification
C1269815 (UMLS CUI-1)
Patient identification
Item
Subjects Identification
integer
C1269815 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Time; Date in time
Item
Actual date/ time
datetime
C0040223 (UMLS CUI [1,1])
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])
Item Group
12- Lead ECG
C0430456 (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])
undefined item
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
EKG finding
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
Summary Holter
C0013801 (UMLS CUI-1)
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])
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])
Item
Interpretation of Holter
integer
C0013801 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])
undefined item
Code List
Interpretation of Holter
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)
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])
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])
Item
Record clinically significant abnormalities below. Check all that apply.
text
C0013801 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
Holter Electrocardiography; Electrocardiogram abnormal
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])
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])
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])
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])
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])
ECG abnormality; Other; Specification | Cardiologists; Comment
Item
If other ecg abnormality, please specify / Cardiologist comments
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
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