ID

31426

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

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

GlaxoSmithKline

Uploaded on

August 21, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384

Investigational Product (Doses AM and PM) and Meal

Investigational Product (Dose a.m.)
Description

Investigational Product (Dose a.m.)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C3174092
UMLS CUI-3
C4331833
Date/ time of dose
Description

Experimental drug; Dosage; Date in time | Experimental drug; Dosage; Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0040223
Treatment Confirmation (Dose a.m.)
Description

Treatment Confirmation (Dose a.m.)

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
UMLS CUI-3
C4331833
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Description

Therapeutic procedure; Correct (qualifier) | Medication dose; Interval

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C1272706
If subject did not receive correct treatment, please record reasons.
Description

Therapeutic procedure; Correct (qualifier); Indication of (contextual qualifier)

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [1,3]
C0392360
Investigational Product (Dose p.m.)
Description

Investigational Product (Dose p.m.)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C3174092
UMLS CUI-3
C1509133
Date/ time of dose
Description

Experimental drug; Dosage; Date in time | Experimental drug; Dosage; Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0040223
Treatment Confirmation (Dose p.m.)
Description

Treatment Confirmation (Dose p.m.)

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
UMLS CUI-3
C1509133
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Description

Therapeutic procedure; Correct (qualifier) | Medication dose; Interval

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C1272706
If subject did not receive correct treatment, please record reasons.
Description

Therapeutic procedure; Correct (qualifier); Indication of (contextual qualifier)

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [1,3]
C0392360
Meal (Breakfast)
Description

Meal (Breakfast)

Alias
UMLS CUI-1
C1998602
Start Date and Time of Meal
Description

Meal (occasion for eating); Start Date | Meal (occasion for eating); Start time

Data type

datetime

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C1998602
UMLS CUI [2,2]
C1301880
End Date and Time of Meal
Description

Meal (occasion for eating); End date | Meal (occasion for eating); End Time

Data type

datetime

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C1998602
UMLS CUI [2,2]
C1522314
Percentage of meal completed
Description

Meal (occasion for eating); Complete; Percent (qualifier value)

Data type

integer

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0439165

Similar models

Investigational Product (Doses AM and PM) and Meal

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Investigational Product (Dose a.m.)
C0304229 (UMLS CUI-1)
C3174092 (UMLS CUI-2)
C4331833 (UMLS CUI-3)
Experimental drug; Dosage; Date in time | Experimental drug; Dosage; Time
Item
Date/ time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Treatment Confirmation (Dose a.m.)
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C4331833 (UMLS CUI-3)
Therapeutic procedure; Correct (qualifier) | Medication dose; Interval
Item
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C3174092 (UMLS CUI [2,1])
C1272706 (UMLS CUI [2,2])
Therapeutic procedure; Correct (qualifier); Indication of (contextual qualifier)
Item
If subject did not receive correct treatment, please record reasons.
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Investigational Product (Dose p.m.)
C0304229 (UMLS CUI-1)
C3174092 (UMLS CUI-2)
C1509133 (UMLS CUI-3)
Experimental drug; Dosage; Date in time | Experimental drug; Dosage; Time
Item
Date/ time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Treatment Confirmation (Dose p.m.)
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1509133 (UMLS CUI-3)
Therapeutic procedure; Correct (qualifier) | Medication dose; Interval
Item
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C3174092 (UMLS CUI [2,1])
C1272706 (UMLS CUI [2,2])
Therapeutic procedure; Correct (qualifier); Indication of (contextual qualifier)
Item
If subject did not receive correct treatment, please record reasons.
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Meal (Breakfast)
C1998602 (UMLS CUI-1)
Meal (occasion for eating); Start Date | Meal (occasion for eating); Start time
Item
Start Date and Time of Meal
datetime
C1998602 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1998602 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Meal (occasion for eating); End date | Meal (occasion for eating); End Time
Item
End Date and Time of Meal
datetime
C1998602 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1998602 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item
Percentage of meal completed
integer
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Code List
Percentage of meal completed
CL Item
1 - 25% (1)
CL Item
26 - 50% (2)
CL Item
51 - 75% (3)
CL Item
76 - 100% (4)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial