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ID
31420
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 (2)
- 21-08-18 21-08-18 -
- 21-08-18 21-08-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
21 augustus 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384
Vital Signs and ECG - Predose and Post- dose
- StudyEvent: ODM
Similar models
Vital Signs and ECG - Predose and Post- dose
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
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])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
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])
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])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (2)
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)
C0439568 (UMLS CUI-2)
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])
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])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (2)
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)
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])
C0013227 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
C0040223 (UMLS CUI [2,4])
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)
C0439568 (UMLS CUI-2)
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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