ID

31427

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 (1)
  1. 8/21/18 8/21/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 21, 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

English

Vital Signs and ECG - Follow up

1 forms  
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/ time
Description

Time; Date in time

Data type

datetime

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0011008
Blood pressure (systolic/ diastolic)
Description

Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Description

heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Description

Respiratory rate

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
12- Lead ECG
Description

12- Lead ECG

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

Electrocardiogram Collection Date Time

Data type

datetime

Alias
UMLS CUI [1]
C2826846
Heart rate
Description

heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Description

Electrocardiogram: P-R interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Description

QRS complex duration (observable entity)

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Description

QT interval feature (observable entity)

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429028
msec
QTc Interval
Description

qtc interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Method of QTc Calculation
Description

qtc interval; Evaluation Method

Data type

integer

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

EKG finding

Data type

integer

Alias
UMLS CUI [1]
C0438154
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Similar models

Vital Signs and ECG - Follow up

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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)
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