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Concomitant medication

1 Formulär  
  1. StudyEvent: ODM
    1. Concomitant medication
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Concomitant medication
Beskrivning

Concomitant medication

Alias
UMLS CUI-1
C2347852
Were any disease specific concomitant medications taken by the subject prior to screening and/or during the study?
Beskrivning

If Yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

Datatyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1883727
Drug name
Beskrivning

use of Trade Names is preferred.

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2347852
Unit Dose, medication
Beskrivning

Unit Dose, medication

Datatyp

integer

Alias
UMLS CUI [1]
C0869039
Units, medication
Beskrivning

Units, medication

Datatyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency, medication
Beskrivning

Frequency, medication

Datatyp

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Route, medication
Beskrivning

Route, medication

Datatyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Reason for medication
Beskrivning

Ensure that the 'Reason for Medication' is recorded on one of the following forms using the same terms: Current Medical Conditions, Non-Serious Adverse Events, Serious Adverse Events Form

Datatyp

text

Alias
UMLS CUI [1]
C2826696
Start date, medication
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C2826734
Start time, medication
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C2347852
Taken prior to study?
Beskrivning

Taken prior to study

Datatyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
Stop date, medication
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C2826744
Stop time, medication
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1]
C2826659
Ongoing medication?
Beskrivning

Ongoing medication

Datatyp

text

Alias
UMLS CUI [1]
C2826666
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Similar models

Concomitant medication

1 Formulär
  1. StudyEvent: ODM
    1. Concomitant medication
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Item
Were any disease specific concomitant medications taken by the subject prior to screening and/or during the study?
text
C2347852 (UMLS CUI [1,1])
C1883727 (UMLS CUI [1,2])
Concomitant medication taken
Code List
Were any disease specific concomitant medications taken by the subject prior to screening and/or during the study?
CL Item
Yes (Y)
CL Item
No (N)
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Unit Dose, medication
Item
Unit Dose, medication
integer
C0869039 (UMLS CUI [1])
Item
Units, medication
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Units, medication
Code List
Units, medication
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Frequency, medication
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Frequency, medication
Code List
Frequency, medication
CL Item
1 X Daily (OD/QD)
CL Item
2 X Daily (BID)
CL Item
3 x Daily (TIO)
CL Item
4 x Daily (QID)
CL Item
As required (PRN)
CL Item
Single dose (ONCE)
Item
Route, medication
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Route, medication
Code List
Route, medication
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Reason for medication
Item
Reason for medication
text
C2826696 (UMLS CUI [1])
Start date, medication
Item
Start date, medication
date
C2826734 (UMLS CUI [1])
Start time, medication
Item
Start time, medication
time
C1301880 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Taken prior to study?
text
C2347852 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Taken prior to study
Code List
Taken prior to study?
CL Item
Yes (Y)
CL Item
No (N)
Stop date, medication
Item
Stop date, medication
date
C2826744 (UMLS CUI [1])
Stop time, medication
Item
Stop time, medication
time
C2826659 (UMLS CUI [1])
Item
Ongoing medication?
text
C2826666 (UMLS CUI [1])
Ongoing medication
Code List
Ongoing medication?
CL Item
Yes (Y)
CL Item
No (N)
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