ID

31482

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 (1)
  1. 8/27/18 8/27/18 -
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

Non- Serious and Serious Adverse Event

1 forms  
Non- serious Adverse Event
Description

Non- serious Adverse Event

Alias
UMLS CUI-1
C1518404
Non- Serious Adverse Event (Diagnosis only [if known], otherwise Sign/ Symptoms)
Description

Non-serious adverse event; Diagnosis | Non-serious adverse event; Signs and Symptoms

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0037088
Non- Serious Adverse Event Start Date and Time
Description

Adverse Event Start Date Time

Data type

datetime

Alias
UMLS CUI [1]
C2826806
Non- Serious Adverse Event Outcome
Description

Adverse Event Outcome; Non-serious Adverse Event

Data type

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
If Non- Serious Adverse Event Outcome was Recovered/ Resolved or Recovered/ Resolved with sequelae, pleas provide End Date and Time
Description

Adverse Event Outcome | Adverse Event End Date Time

Data type

datetime

Alias
UMLS CUI [1]
C1705586
UMLS CUI [2]
C2826793
Non- Serious Adverse Event Frequency
Description

Non- serious adverse event; Frequencies (time pattern)

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Intensity of Non- Serious Adverse Event
Description

Severity of Adverse Event

Data type

integer

Alias
UMLS CUI [1]
C1710066
Maximum Grade of Adverse Event
Description

Non-serious adverse event; Grade

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0441800
Maximum Grade or Intensity of Non- serious Adverse Event
Description

Adverse event; Grade | Severity of Adverse Event

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0441800
UMLS CUI [2]
C1710066
Action taken with Investigational Product(s) as a Result of the Non- serious Adverse Event
Description

Experimental drug; Treatment modification | Non-serious Adverse event

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1299575
UMLS CUI [2]
C1518404
Did the subject withdraw from study as a result of this Non- serious Adverse Event?
Description

Study Withdrawn | Non- serious Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C2348571
UMLS CUI [2]
C1518404
Is there a reasonable possibility that the Non- serious Adverse Event may have been caused by the investigational product?
Description

Experimental drug; Non-serious Adverse event; Causations

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C0085978
Duration of Non- serious Adverse Event if <24 hours
Description

Non-serious Adverse event; Duration (temporal concept)

Data type

durationDatetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449238
Time to Onset of Non- serious Adverse Event Since Last Dose
Description

Non-serious Adverse event; Time of onset; Date last dose

Data type

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0449244
UMLS CUI [1,3]
C1762893
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Type of Report
Description

Report type

Data type

integer

Alias
UMLS CUI [1]
C0585733
Did Serious Adverse Event occur after initiation of study medication?
Description

Serious Adverse Event; Experimental drug; Post

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0687676
Serious Adverse Event (Diagnosis only [if known], otherwise Signs/ Symptoms)
Description

Serious Adverse Event; Diagnosis | Serious Adverse Event; Signs and Symptoms

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0037088
Serious Adverse Event Start Date and Time
Description

Serious Adverse Event; Start Date | Serious Adverse Event; Start time

Data type

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1301880
Serious Adverse Event Outcome
Description

Adverse Event Outcome; Serious Adverse Event

Data type

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
If Serious Adverse Event Outcome was Recovered/ Resolved or Recovered/ Resolved with sequelae, pleas provide End Date and Time
Description

Adverse Event Outcome | Adverse Event End Date Time

Data type

datetime

Alias
UMLS CUI [1]
C1705586
UMLS CUI [2]
C2826793
Maximum Intensity of Serious Adverse Event
Description

Severity of Adverse Event

Data type

integer

Alias
UMLS CUI [1]
C1710066
Maximum Grade of Serious Adverse Event
Description

Serious Adverse event; Grade

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
Maximum Grade or Intensity of Serious Adverse Event
Description

Serious Adverse event; Grade | Severity of Adverse Event

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [2]
C1710066
Action taken with Investigational Product(s) as a Result of the Serious Adverse Event
Description

Experimental drug; Treatment modification | Serious Adverse event

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1299575
UMLS CUI [2]
C1519255
Did the subject withdraw from study as a result of this Serious Adverse Event?
Description

Study Withdrawn | Serious Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C2348571
UMLS CUI [2]
C1519255
Is there a reasonable possibility that the Serious Adverse Event may have been caused by the investigational product?
Description

Experimental drug; Serious Adverse event; Causations

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0085978
Duration of Serious Adverse Event if <24 hours
Description

Serious Adverse event; Duration (temporal concept)

Data type

durationDatetime

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0449238
Time to Onset of Serious Adverse Event Since Last Dose
Description

Serious Adverse event; Time of onset; Date last dose

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449244
UMLS CUI [1,3]
C1762893
Was the Serious Adverse Event caused by activities related to study participation (e. g. procedures?)
Description

Serious Adverse Event; Study Treatment Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3641099
Was the event serious?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Specify Seriousness of Serious Adverse Event
Description

Seriousness of Adverse Event; Serious Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
Relevant Concomitant/ Tratment Medications
Description

Relevant Concomitant/ Tratment Medications

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C1707479
Drug Name (Trade Name preferred)
Description

Medication name

Data type

text

Alias
UMLS CUI [1]
C2360065
Concomitant Medication Dose
Description

Concomitant Therapy; Medication dose

Data type

text

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C3174092
Unit
Description

Unit

Data type

text

Alias
UMLS CUI [1]
C0439148
Medication 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
Concomitant Medication 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 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
Primary Indication for Concomitant Medication
Description

Concomitant Medication Use Indication

Data type

text

Alias
UMLS CUI [1]
C2826696
Drug Type
Description

Types of drugs

Data type

text

Alias
UMLS CUI [1]
C0457591
Relevant medical conditions/ risk factors
Description

Relevant medical conditions/ risk factors

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0035648
Specific Condition Name
Description

Disease; Specification

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Date of Onset
Description

Date of onset

Data type

date

Alias
UMLS CUI [1]
C0574845
Is disease/ risk factor continuing?
Description

Disease; Continuous | risk factors; Continuous

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0549178
If disease/ risk factors are not continuing, specify date of last occurence.
Description

Disease; Occurrence; Date in time | risk factors; Occurrence; Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C2745955
UMLS CUI [2,3]
C0011008
Relevant Medical History/ Risk Factors not noted above
Description

Medical History | risk factors

Data type

text

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0035648
Relevant Diagnostic Results
Description

Relevant Diagnostic Results

Alias
UMLS CUI-1
C0430022
UMLS CUI-2
C1274040
Diagnostic Test Name
Description

diagnostic procedure; Test Name

Data type

integer

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C2826273
Test Date
Description

Test Date

Data type

date

Alias
UMLS CUI [1]
C2826247
Test Result
Description

Test Result

Data type

text

Alias
UMLS CUI [1]
C0456984
Relevant diagnostic results not noted above
Description

diagnostic procedure; Result

Data type

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1274040
Investigational Products
Description

Investigational Products

Alias
UMLS CUI-1
C0304229
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) werde administered?
Description

Experimental drug; Adverse event; Recurrence

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0034897
General Narrative Comments
Description

General Narrative Comments

Alias
UMLS CUI-1
C0947611
General Narrative Comments
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Non- Serious and Serious Adverse Event

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Non- serious Adverse Event
C1518404 (UMLS CUI-1)
Non-serious adverse event; Diagnosis | Non-serious adverse event; Signs and Symptoms
Item
Non- Serious Adverse Event (Diagnosis only [if known], otherwise Sign/ Symptoms)
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
Adverse Event Start Date Time
Item
Non- Serious Adverse Event Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Item
Non- Serious Adverse Event Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Adverse Event Outcome
Code List
Non- Serious Adverse Event Outcome
CL Item
Recovered/ Resolved (provide End Date and Time) (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (provide End Date and Time) (4)
Adverse Event Outcome | Adverse Event End Date Time
Item
If Non- Serious Adverse Event Outcome was Recovered/ Resolved or Recovered/ Resolved with sequelae, pleas provide End Date and Time
datetime
C1705586 (UMLS CUI [1])
C2826793 (UMLS CUI [2])
Item
Non- Serious Adverse Event Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
undefined item
Code List
Non- Serious Adverse Event Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity of Non- Serious Adverse Event
integer
C1710066 (UMLS CUI [1])
Severity of Adverse Event
Code List
Maximum Intensity of Non- Serious Adverse Event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Maximum Grade of Adverse Event
integer
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
undefined item
Code List
Maximum Grade of Adverse Event
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Maximum Grade or Intensity of Non- serious Adverse Event
integer
C0877248 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C1710066 (UMLS CUI [2])
undefined item
Code List
Maximum Grade or Intensity of Non- serious Adverse Event
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Action taken with Investigational Product(s) as a Result of the Non- serious Adverse Event
integer
C0304229 (UMLS CUI [1,1])
C1299575 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
undefined item
Code List
Action taken with Investigational Product(s) as a Result of the Non- serious Adverse Event
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Study Withdrawn | Non- serious Adverse event
Item
Did the subject withdraw from study as a result of this Non- serious Adverse Event?
boolean
C2348571 (UMLS CUI [1])
C1518404 (UMLS CUI [2])
Experimental drug; Non-serious Adverse event; Causations
Item
Is there a reasonable possibility that the Non- serious Adverse Event may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Non-serious Adverse event; Duration (temporal concept)
Item
Duration of Non- serious Adverse Event if <24 hours
durationDatetime
C1518404 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Non-serious Adverse event; Time of onset; Date last dose
Item
Time to Onset of Non- serious Adverse Event Since Last Dose
time
C1518404 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Item
Type of Report
integer
C0585733 (UMLS CUI [1])
undefined item
Code List
Type of Report
CL Item
Initial report (1)
CL Item
Follow- Up (2)
Serious Adverse Event; Experimental drug; Post
Item
Did Serious Adverse Event occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Serious Adverse Event; Diagnosis | Serious Adverse Event; Signs and Symptoms
Item
Serious Adverse Event (Diagnosis only [if known], otherwise Signs/ Symptoms)
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
Serious Adverse Event; Start Date | Serious Adverse Event; Start time
Item
Serious Adverse Event Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Item
Serious Adverse Event Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Adverse Event Outcome; Serious Adverse Event
Code List
Serious Adverse Event Outcome
CL Item
Recovered/ Resolved (provide End Date and Time)  (1)
CL Item
Recovering/ Resolving  (2)
CL Item
Not recovered/ Not resolved  (3)
CL Item
Recovered/ Resolved with sequelae (provide End Date and Time) (4)
Adverse Event Outcome | Adverse Event End Date Time
Item
If Serious Adverse Event Outcome was Recovered/ Resolved or Recovered/ Resolved with sequelae, pleas provide End Date and Time
datetime
C1705586 (UMLS CUI [1])
C2826793 (UMLS CUI [2])
Item
Maximum Intensity of Serious Adverse Event
integer
C1710066 (UMLS CUI [1])
Severity of Adverse Event
Code List
Maximum Intensity of Serious Adverse Event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe  (3)
CL Item
Not applicable (4)
Item
Maximum Grade of Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Serious Adverse event; Grade
Code List
Maximum Grade of Serious Adverse Event
CL Item
Grade 1  (1)
CL Item
Grade 2  (2)
CL Item
Grade 3  (3)
CL Item
Grade 4  (4)
CL Item
Grade 5  (5)
CL Item
Not applicable (6)
Item
Maximum Grade or Intensity of Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C1710066 (UMLS CUI [2])
Serious Adverse event; Grade | Severity of Adverse Event
Code List
Maximum Grade or Intensity of Serious Adverse Event
CL Item
Mild or Grade 1  (1)
CL Item
Moderate or Grade 2  (2)
CL Item
Severe or Grade 3  (3)
CL Item
Grade 4  (4)
CL Item
Grade 5  (5)
CL Item
Not applicable (6)
Item
Action taken with Investigational Product(s) as a Result of the Serious Adverse Event
integer
C0304229 (UMLS CUI [1,1])
C1299575 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Experimental drug; Treatment modification | Serious Adverse event
Code List
Action taken with Investigational Product(s) as a Result of the Serious Adverse Event
CL Item
Investigational product(s) withdrawn  (1)
CL Item
Dose reduced  (2)
CL Item
Dose increased  (3)
CL Item
Dose not changed  (4)
CL Item
Dose interrupted  (5)
CL Item
Not applicable (6)
Study Withdrawn | Serious Adverse event
Item
Did the subject withdraw from study as a result of this Serious Adverse Event?
boolean
C2348571 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Experimental drug; Serious Adverse event; Causations
Item
Is there a reasonable possibility that the Serious Adverse Event may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Serious Adverse event; Duration (temporal concept)
Item
Duration of Serious Adverse Event if <24 hours
durationDatetime
C0449238 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Serious Adverse event; Time of onset; Date last dose
Item
Time to Onset of Serious Adverse Event Since Last Dose
time
C1519255 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
Serious Adverse Event; Study Treatment Causality
Item
Was the Serious Adverse Event caused by activities related to study participation (e. g. procedures?)
boolean
C1519255 (UMLS CUI [1,1])
C3641099 (UMLS CUI [1,2])
Serious Adverse Event
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Item
Specify Seriousness of Serious Adverse Event
text
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Seriousness of Adverse Event; Serious Adverse Event
Code List
Specify Seriousness of Serious Adverse Event
CL Item
Results in Death (A)
CL Item
Is life- threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/ incapacity (D)
CL Item
Congenital anormaly/ borth defect (E)
CL Item
Other, specify within general narrative comment (F)
Item Group
Relevant Concomitant/ Tratment Medications
C0013227 (UMLS CUI-1)
C1707479 (UMLS CUI-2)
Medication name
Item
Drug Name (Trade Name preferred)
text
C2360065 (UMLS CUI [1])
Concomitant Therapy; Medication dose
Item
Concomitant Medication Dose
text
C1707479 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Item
Unit
text
C0439148 (UMLS CUI [1])
Unit
Code List
Unit
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
Medication Frequency
integer
C3476109 (UMLS CUI [1])
Medication frequency
Code List
Medication 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
Every 2 weeks (8)
CL Item
Every 3 weeks (9)
CL Item
Evey 3 month (10)
CL Item
Every other day (11)
CL Item
At Bedtime (12)
CL Item
Once a month (13)
CL Item
Once a week (14)
CL Item
Once daily (15)
CL Item
Once only (16)
CL Item
PC (17)
CL Item
PRN (18)
CL Item
Q2H (19)
CL Item
Q3D (20)
CL Item
Q4D (21)
CL Item
Q4H (22)
CL Item
Q6H (23)
CL Item
Q8H (24)
CL Item
Q12H (25)
CL Item
QAM (26)
CL Item
QH (27)
CL Item
QID (28)
CL Item
QPM (29)
CL Item
TID (30)
CL Item
Unknown (31)
Item
Medication Route
integer
C0013153 (UMLS CUI [1])
Drug Administration Routes
Code List
Medication Route
CL Item
Both eyes (1)
CL Item
Epidural (2)
CL Item
Gastrostomy tube (3)
CL Item
Inhalation (4)
CL Item
Injection (5)
CL Item
Intra- arterial (6)
CL Item
Intra- brusa (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
Nasal (18)
CL Item
Oral (19)
CL Item
Rectal (20)
CL Item
Subcutaneous (21)
CL Item
Sublingual (22)
CL Item
Topical (23)
CL Item
Transdermal (24)
CL Item
Unknown (25)
CL Item
Vaginal  (26)
Concomitant Medication Start Date | Pharmaceutical Preparations; Concomitant Therapy; Start time
Item
Concomitant Medication Start Date and Time
datetime
C2826734 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1707479 (UMLS CUI [2,2])
C1301880 (UMLS CUI [2,3])
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])
Concomitant Medication Use Indication
Item
Primary Indication for Concomitant Medication
text
C2826696 (UMLS CUI [1])
Item
Drug Type
text
C0457591 (UMLS CUI [1])
Types of drugs
Code List
Drug Type
CL Item
Concomitant (2)
CL Item
Treatment (T)
CL Item
Cause of SAE (1)
Item Group
Relevant medical conditions/ risk factors
C0012634 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
Disease; Specification
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Date of onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1])
Item
Is disease/ risk factor continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
Disease; Continuous | risk factors; Continuous
Code List
Is disease/ risk factor continuing?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Disease; Occurrence; Date in time | risk factors; Occurrence; Date in time
Item
If disease/ risk factors are not continuing, specify date of last occurence.
date
C0012634 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
Medical History | risk factors
Item
Relevant Medical History/ Risk Factors not noted above
text
C0262926 (UMLS CUI [1])
C0035648 (UMLS CUI [2])
Item Group
Relevant Diagnostic Results
C0430022 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
Item
Diagnostic Test Name
integer
C0430022 (UMLS CUI [1,1])
C2826273 (UMLS CUI [1,2])
undefined item
Code List
Diagnostic Test Name
CL Item
Activated partial thromboplastin time (1)
CL Item
Albumin (2)
CL Item
Alkaline phosphatase (3)
CL Item
Amylase (4)
CL Item
Basophils (5)
CL Item
Bicarbonate (6)
CL Item
Bilirubin (7)
CL Item
Bilirubin direct (8)
CL Item
Bilirubin total (9)
CL Item
Blood myoglobin (10)
CL Item
Blood pH (11)
CL Item
Blood pressure (12)
CL Item
Blood urea nitrogen (13)
CL Item
Body temperature (14)
CL Item
Calcium (15)
CL Item
CD4 lymphoctes (16)
CL Item
CD8 lymphocytes (17)
CL Item
Chloride (18)
CL Item
Cholesterol total (19)
CL Item
C- reactive protein (20)
CL Item
Creatine (21)
CL Item
Creatine phosphokinase (22)
CL Item
Creatine phosphokinase MB (23)
CL Item
Creatinine (24)
CL Item
Creatinine clearance (25)
CL Item
Diastolic blood pressure (26)
CL Item
Eosinophils (27)
CL Item
Erythrocyte sedimentation rate (28)
CL Item
Fasting blood glucose (29)
CL Item
FEV 1 (30)
CL Item
Gamme- glutamyltransferase (31)
CL Item
Glutamic- oxaloacetic transferase (32)
CL Item
Glumatic- pyruvate transaminase (33)
CL Item
HbA1c (34)
CL Item
HBV- DNA decreased (35)
CL Item
HBV- DNA increased (36)
CL Item
Heart rate (37)
CL Item
Hematocrit (38)
CL Item
Hemoglobin (39)
CL Item
High density lipoprotein (40)
CL Item
HIV viral load (41)
CL Item
INR (42)
CL Item
Lactic dehydrogenase (43)
CL Item
Lipase (44)
CL Item
Low density lipoprotein (45)
CL Item
Lymphocytes (46)
CL Item
Magnesium (47)
CL Item
Mean cell hemoglobin concentration (48)
CL Item
Mean corpuscular volume (49)
CL Item
Monocytes (50)
CL Item
Neutrophils (51)
CL Item
Oxygen saturation (52)
CL Item
pCO2 (53)
CL Item
pH (54)
CL Item
Phosphate (55)
CL Item
Platelet count (56)
CL Item
pO2 (57)
CL Item
pO2 (58)
CL Item
Potassium (59)
CL Item
Protein total (60)
CL Item
Prothrombin time (61)
CL Item
Red blood cell count (62)
CL Item
Respiratory rate (63)
CL Item
Reticulocyte count (64)
CL Item
Serum glucose (65)
CL Item
Serum uric acid (66)
CL Item
Sodium (67)
CL Item
Systolic blood pressure (68)
CL Item
Thrombin time (69)
CL Item
Total lung capacity (70)
CL Item
Triglycerides (71)
CL Item
Troponin (72)
CL Item
Troponin I (73)
CL Item
Troponin T (74)
CL Item
Urine myoglobin (75)
CL Item
Urine pH (76)
CL Item
Vital capacity (77)
CL Item
White blood cell count (78)
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0456984 (UMLS CUI [1])
diagnostic procedure; Result
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item Group
Investigational Products
C0304229 (UMLS CUI-1)
Item
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) werde administered?
text
C0304229 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,3])
Experimental drug; Adverse event; Recurrence
Code List
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) werde administered?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
General Narrative Comments
C0947611 (UMLS CUI-1)
Comment
Item
General Narrative Comments
text
C0947611 (UMLS CUI [1])
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