ID

31480

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. 8/27/18 8/27/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 27, 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

Logs and Repeats and Concomitant Medications

1 forms  
Date of visit/ assessment
Description

Date of visit/ assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/ assessment
Description

Date of visit/ assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Adverse Event/ Concomitant medication/ Repeat assessment check questions
Description

Adverse Event/ Concomitant medication/ Repeat assessment check questions

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2826666
UMLS CUI-3
C0220825
Were any concomitant medications taken by the subject during the study?
Description

Pharmaceutical Preparations Concomitant Therapy; Concomitant Medications; Study; During

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1707479
UMLS CUI [1,3]
C2603343
UMLS CUI [1,4]
C0347984
Did the subject experience any non- serious adverse events during the study?
Description

Non-serious Adverse Event; Study; During

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C0347984
Did the subject experience any serious adverse events during the study?
Description

Serious Adverse Event; Study; During

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C0347984
Were any repeat hematology or clinical chemistry samples taken?
Description

Hematologic Tests; Blood sample taken; Repeat | Chemistry, Clinical; Specimen Collection; Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1277698
UMLS CUI [1,3]
C0205341
UMLS CUI [2,1]
C0008000
UMLS CUI [2,2]
C0200345
UMLS CUI [2,3]
C0205341
Were any repeat urinalysis samples taken?
Description

Urinalysis; Specimen Collection; Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0205341
Were any repeat ECGs performed?
Description

Electrocardiogram; Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205341
Were any clinically significant ECG abnormaliites?
Description

ECG abnormality; Clinically Significant Indicator

Data type

boolean

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C2985739
Were any repeat vital signs recorded?
Description

Vital signs; Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Were any repeat PK blood samples taken?
Description

Blood sample taken; Drug Kinetics; Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
UMLS CUI [1,3]
C0205341
Was any repeat Holter monitoring performed?
Description

Holter Electrocardiography; Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0205341
Were any clinically significant Holter abnormalities?
Description

Holter Electrocardiography; Electrocardiogram abnormal; Clinically Significant Indicator

Data type

boolean

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0522055
UMLS CUI [1,3]
C2985739
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C1707479
Medication Sequence Number
Description

Pharmaceutical Preparations; Concomitant Therapy; Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1707479
UMLS CUI [1,3]
C2348184
Drug Name (Trade Name preferred)
Description

Medication name

Data type

text

Alias
UMLS CUI [1]
C2360065
Concomitant Medication Unit Dose
Description

Concomitant Medication Dose Unit

Data type

float

Alias
UMLS CUI [1]
C2826646
Units
Description

Unit

Data type

integer

Alias
UMLS CUI [1]
C0439148
Mediacation Frequency
Description

Medication frequency

Data type

integer

Alias
UMLS CUI [1]
C3476109
Medication Route
Description

Drug Administration Routes

Data type

integer

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Description

Concomitant Medication Use Indication

Data type

text

Alias
UMLS CUI [1]
C2826696
Start Date and Time
Description

Concomitant Medication Start Date | Pharmaceutical Preparations; Concomitant Therapy; Start time

Data type

datetime

Alias
UMLS CUI [1]
C2826734
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1707479
UMLS CUI [2,3]
C1301880
Concomitant medication taken prior to study?
Description

Pharmaceutical Preparations; Concomitant Therapy; Study; Before

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1707479
UMLS CUI [1,3]
C2603343
UMLS CUI [1,4]
C0332152
Concomitant Medication Ongoing?
Description

Concomitant Medication Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826666
If concomitant medication not ongoing, specify End Date and Time.
Description

Concomitant Medication End Date | Pharmaceutical Preparations; Concomitant Therapy; End Time

Data type

datetime

Alias
UMLS CUI [1]
C2826744
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1707479
UMLS CUI [2,3]
C1522314
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Similar models

Logs and Repeats and Concomitant Medications

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of visit/ assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit/ assessment
Item
Date of visit/ assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Adverse Event/ Concomitant medication/ Repeat assessment check questions
C0877248 (UMLS CUI-1)
C2826666 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Pharmaceutical Preparations Concomitant Therapy; Concomitant Medications; Study; During
Item
Were any concomitant medications taken by the subject during the study?
boolean
C0013227 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
Non-serious Adverse Event; Study; During
Item
Did the subject experience any non- serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Serious Adverse Event; Study; During
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Hematologic Tests; Blood sample taken; Repeat | Chemistry, Clinical; Specimen Collection; Repeat
Item
Were any repeat hematology or clinical chemistry samples taken?
boolean
C0018941 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
Urinalysis; Specimen Collection; Repeat
Item
Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Electrocardiogram; Repeat
Item
Were any repeat ECGs performed?
boolean
C0013798 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
ECG abnormality; Clinically Significant Indicator
Item
Were any clinically significant ECG abnormaliites?
boolean
C1832603 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Vital signs; Repeat
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Blood sample taken; Drug Kinetics; Repeat
Item
Were any repeat PK blood samples taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Holter Electrocardiography; Repeat
Item
Was any repeat Holter monitoring performed?
boolean
C0013801 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Holter Electrocardiography; Electrocardiogram abnormal; Clinically Significant Indicator
Item
Were any clinically significant Holter abnormalities?
boolean
C0013801 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Item Group
Concomitant Medications
C0013227 (UMLS CUI-1)
C1707479 (UMLS CUI-2)
Pharmaceutical Preparations; Concomitant Therapy; Sequence Number
Item
Medication Sequence Number
integer
C0013227 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Medication name
Item
Drug Name (Trade Name preferred)
text
C2360065 (UMLS CUI [1])
Concomitant Medication Dose Unit
Item
Concomitant Medication Unit Dose
float
C2826646 (UMLS CUI [1])
Item
Units
integer
C0439148 (UMLS CUI [1])
Unit
Code List
Units
CL Item
Actuation (1)
CL Item
Ampoule (2)
CL Item
Application (3)
CL Item
Area under curve (4)
CL Item
Bottle (5)
CL Item
Capsule (6)
CL Item
Cubic centimeter (7)
CL Item
Cup (8)
CL Item
Gamma per kilogram per minute (9)
CL Item
Gram (10)
CL Item
Drops (11)
CL Item
100 International units/ml (12)
CL Item
Inhalation (13)
CL Item
International units (14)
CL Item
International units per kilogram (15)
CL Item
International units per kilogram per hour (16)
CL Item
International units per mililitre (17)
CL Item
Litre (18)
CL Item
Lozenge (19)
CL Item
Litre per minute (20)
CL Item
Minimum alveolar concentration (21)
CL Item
Mega becquerels (Mbq) (22)
CL Item
Microgram (MCG) (23)
CL Item
Micrograms per hour (24)
CL Item
Microgram/ kilogram (25)
CL Item
Microgram/ kilogram per minute (26)
CL Item
Micrograms per minute (27)
CL Item
Micrograms per mililitre (28)
CL Item
Microlitre (29)
CL Item
Milliequivalent (30)
CL Item
Milliequivalent per 24 hours (31)
CL Item
Miligram (32)
CL Item
Miligram per day (33)
CL Item
Miligram per hour (34)
CL Item
Miligram/ kilogram (35)
CL Item
Miligram/ kilogram per hour (36)
CL Item
Miligram/ kilogram per minute (37)
CL Item
Miligram/ metre squared (38)
CL Item
Miligram/ mililitre (39)
CL Item
Miligrams percent (40)
CL Item
Million international units (41)
CL Item
Mililitre (42)
CL Item
Mililitre per hour (43)
CL Item
Mililitre per minute (44)
CL Item
Milimole (45)
CL Item
Megaunits (million units) (46)
CL Item
Nebule (47)
CL Item
Ounce (48)
CL Item
Patch (49)
CL Item
Percent (50)
CL Item
Puff (51)
CL Item
Sachet (52)
CL Item
Spray (53)
CL Item
Suppository (54)
CL Item
Tablet (55)
CL Item
Tablespoon (56)
CL Item
Teaspoon (57)
CL Item
Microgram (UG) (58)
CL Item
Units per hour (59)
CL Item
Units per kilogram pe rminute (60)
CL Item
Units per minute (61)
CL Item
Units (62)
CL Item
Unknown (63)
CL Item
Vial (64)
Item
Mediacation Frequency
integer
C3476109 (UMLS CUI [1])
Medication frequency
Code List
Mediacation Frequency
CL Item
2 times per week (1)
CL Item
3 times per week (2)
CL Item
4 times per week (3)
CL Item
5 times per day (4)
CL Item
5 times per week (5)
CL Item
AC (6)
CL Item
BID (7)
CL Item
Continious infusion (8)
CL Item
HS (9)
CL Item
Once daily (10)
CL Item
Once only (11)
CL Item
PC (12)
CL Item
PRN (13)
CL Item
Q12H (14)
CL Item
Q2H (15)
CL Item
Every 2 Weeks (16)
CL Item
Q3D (17)
CL Item
Every 3 month (18)
CL Item
Every 3 weeks (19)
CL Item
Q4D (20)
CL Item
Q4H (21)
CL Item
Q6H (22)
CL Item
Q8H (23)
CL Item
QAM (24)
CL Item
QH (25)
CL Item
QID (26)
CL Item
Once a month (27)
CL Item
Every other day (28)
CL Item
QPM (29)
CL Item
Once a week (30)
CL Item
TID (31)
CL Item
Unknown (32)
Item
Medication Route
integer
C0013153 (UMLS CUI [1])
Drug Administration Routes
Code List
Medication Route
CL Item
Epidural (1)
CL Item
Gastrostomy tube (2)
CL Item
Intra- arterial (3)
CL Item
Intra- articular (4)
CL Item
Intra- brusa (5)
CL Item
Intradermal (6)
CL Item
Inhalation (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Injection (11)
CL Item
Intraocular (12)
CL Item
Intraosteal (13)
CL Item
Intraperitoneal (14)
CL Item
Intrathecal (15)
CL Item
Intrauterine (16)
CL Item
Intrevenous (17)
CL Item
Nasogastric (18)
CL Item
Nasal (19)
CL Item
Right exe (20)
CL Item
Ophthalmic (21)
CL Item
Left eye (22)
CL Item
Otic (23)
CL Item
Other (24)
CL Item
Both eyes (25)
CL Item
Oral (26)
CL Item
Rectal (27)
CL Item
Subcutaneous (28)
CL Item
Sublingual (29)
CL Item
Transdermal (30)
CL Item
Topical (31)
CL Item
Unknown (32)
CL Item
Vaginal (33)
Concomitant Medication Use Indication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Concomitant Medication Start Date | Pharmaceutical Preparations; Concomitant Therapy; Start time
Item
Start Date and Time
datetime
C2826734 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1707479 (UMLS CUI [2,2])
C1301880 (UMLS CUI [2,3])
Pharmaceutical Preparations; Concomitant Therapy; Study; Before
Item
Concomitant medication taken prior to study?
boolean
C0013227 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Concomitant Medication Ongoing
Item
Concomitant Medication Ongoing?
boolean
C2826666 (UMLS CUI [1])
Concomitant Medication End Date | Pharmaceutical Preparations; Concomitant Therapy; End Time
Item
If concomitant medication not ongoing, specify End Date and Time.
datetime
C2826744 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1707479 (UMLS CUI [2,2])
C1522314 (UMLS CUI [2,3])
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