ID

31418

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 (2)
  1. 8/21/18 8/21/18 -
  2. 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

12-Lead ECG

1 forms  
  1. StudyEvent: ODM
    1. 12-Lead ECG
Dosing date/ time
Description

Dosing date/ time

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing date/ time
Description

Pharmaceutical Preparations; Dosage; Date in time; Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Pre- Doses
Description

Pre- Doses

Alias
UMLS CUI-1
C0439565
Pre- Dose number
Description

Pre-dose; Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0439565
UMLS CUI [1,2]
C0237753
Time of ECG
Description

Time; Electrocardiogram

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
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 duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0577807
msec
QTc Interval
Description

qtc interval

Data type

float

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

Electrocardiogram QT corrected interval; Evaluation Method

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Description

EKG finding

Data type

integer

Alias
UMLS CUI [1]
C0438154
Post- Doses
Description

Post- Doses

Alias
UMLS CUI-1
C0439568
Hours Post- dose
Description

Post-dose; Hour

Data type

integer

Alias
UMLS CUI [1,1]
C0439568
UMLS CUI [1,2]
C0439227
Time of ECG
Description

Time; Electrocardiogram

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
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 duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0577807
msec
QTc Interval
Description

qtc interval

Data type

float

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

Electrocardiogram QT corrected interval; Evaluation Method

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
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

12-Lead ECG

1 forms
  1. StudyEvent: ODM
    1. 12-Lead ECG
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Dosing date/ time
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Pharmaceutical Preparations; Dosage; Date in time; Time
Item
Dosing date/ time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Pre- Doses
C0439565 (UMLS CUI-1)
Item
Pre- Dose number
integer
C0439565 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
undefined item
Code List
Pre- Dose number
CL Item
Pre- Dose #1 (1)
CL Item
Pre- Dose #2 (2)
CL Item
Pre- Dose #3 (3)
Time; Electrocardiogram
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
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 duration
Item
Uncorrected QT Interval
float
C0577807 (UMLS CUI [1])
qtc interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Electrocardiogram QT corrected interval; Evaluation Method
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
Post- Doses
C0439568 (UMLS CUI-1)
Item
Hours Post- dose
integer
C0439568 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
undefined item
Code List
Hours Post- dose
CL Item
1.0 hour Post- dose (1)
CL Item
3.0 hours Post- dose (2)
CL Item
5.5 hours Post- dose (3)
CL Item
8.0 hours Post- dose (4)
CL Item
10.0 hours Post- dose (5)
CL Item
12.0 hours Post- dose (6)
CL Item
24.0 hours Post- dose (7)
Time; Electrocardiogram
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
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 duration
Item
Uncorrected QT Interval
float
C0577807 (UMLS CUI [1])
qtc interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Electrocardiogram QT corrected interval; Evaluation Method
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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