ID

31420

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

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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 - Predose and Post- dose

1 forms  
ECG Dosing date/ time
Description

ECG Dosing date/ time

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0013227
UMLS CUI-3
C0178602
UMLS CUI-4
C0011008
UMLS CUI-5
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- Dose ECG
Description

Pre- Dose ECG

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
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- Dose ECG
Description

Post- Dose ECG

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
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
Vital Signs Dosing date and time
Description

Vital Signs Dosing date and time

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0013227
UMLS CUI-3
C0178602
UMLS CUI-4
C0011008
UMLS CUI-5
C0040223
Vital Signs Dosing date and time
Description

Vital signs | Pharmaceutical Preparations; Dosage; Date in time; Time

Data type

datetime

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0011008
UMLS CUI [2,4]
C0040223
Pre- dose Vital Signs
Description

Pre- dose Vital Signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
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
Post- dose Vital signs
Description

Post- dose Vital signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439568
Hours Post- dose
Description

Post-dose; Hour

Data type

integer

Alias
UMLS CUI [1,1]
C0439568
UMLS CUI [1,2]
C0439227
Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
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
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Similar models

Vital Signs and ECG - Predose and Post- dose

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ECG Dosing date/ time
C1623258 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
C0040223 (UMLS CUI-5)
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- Dose ECG
C1623258 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
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- Dose ECG
C1623258 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
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)
Item Group
Vital Signs Dosing date and time
C0518766 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
C0040223 (UMLS CUI-5)
Vital signs | Pharmaceutical Preparations; Dosage; Date in time; Time
Item
Vital Signs Dosing date and time
datetime
C0518766 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
C0040223 (UMLS CUI [2,4])
Item Group
Pre- dose Vital Signs
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Time
Item
Actual time
time
C0040223 (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
Post- dose Vital signs
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Hours Post- dose
integer
C0439568 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Post-dose; Hour
Code List
Hours Post- dose
CL Item
1.0 hours 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
Item
Actual time
time
C0040223 (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])
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