ID

31420

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2018-08-21 2018-08-21 -
  2. 2018-08-21 2018-08-21 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

21 augusti 2018

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

Engelsk

Vital Signs and ECG - Predose and Post- dose

1 Formulär  
ECG Dosing date/ time
Beskrivning

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
Beskrivning

Pharmaceutical Preparations; Dosage; Date in time; Time

Datatyp

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
Beskrivning

Pre- Dose ECG

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0439565
Pre- Dose number
Beskrivning

Pre-dose; Numbers

Datatyp

integer

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

Time; Electrocardiogram

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Heart rate
Beskrivning

heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beskrivning

Electrocardiogram: P-R interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS complex duration (observable entity)

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beskrivning

QT interval duration

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0577807
msec
QTc Interval
Beskrivning

qtc interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Method of QTc Calculation
Beskrivning

Electrocardiogram QT corrected interval; Evaluation Method

Datatyp

integer

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

EKG finding

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
Post- Dose ECG
Beskrivning

Post- Dose ECG

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0439568
Hours Post- dose
Beskrivning

Post-dose; Hour

Datatyp

integer

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

Time; Electrocardiogram

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Heart rate
Beskrivning

heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beskrivning

Electrocardiogram: P-R interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS complex duration (observable entity)

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beskrivning

QT interval duration

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0577807
msec
QTc Interval
Beskrivning

qtc interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Method of QTc Calculation
Beskrivning

Electrocardiogram QT corrected interval; Evaluation Method

Datatyp

integer

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

EKG finding

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
Vital Signs Dosing date and time
Beskrivning

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
Beskrivning

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

Datatyp

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
Beskrivning

Pre- dose Vital Signs

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Blood pressure (systolic/ diastolic)
Beskrivning

Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Beskrivning

heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Beskrivning

Respiratory rate

Datatyp

integer

Måttenheter
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Post- dose Vital signs
Beskrivning

Post- dose Vital signs

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

Post-dose; Hour

Datatyp

integer

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Blood pressure (systolic/ diastolic)
Beskrivning

Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Beskrivning

heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Beskrivning

Respiratory rate

Datatyp

integer

Måttenheter
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Tillbaka till toppen

Similar models

Vital Signs and ECG - Predose and Post- dose

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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