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Concomitant Medication

1 Formulieren  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Workbook number
Beschrijving

Workbook number

Datatype

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Beschrijving

Visit type

Datatype

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Concomitant medication
Beschrijving

Concomitant medication

Alias
UMLS CUI-1
C2347852
Have any medications/treatments been administered during the timeframe as specified by the protocol?
Beschrijving

If you tick "yes" please fill in following items. At each study visit/contact, the investigator should question the subject about any medication(s) taken.

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
Trade/ (Generic) Name
Beschrijving

Trade/ (Generic) Name

Datatype

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C2347852
Medical Indication
Beschrijving

A prophylactic medication is a medication administered in the absence of ANY symptom and in anticipation of a reaction to the vaccination (e.g. an anti-pyretic is considered to be prophylactic when it is given in the absence of fever [rectal temperature < 38°C] and any other symptom, to prevent fever from occurring). Any concomitant medication administered prophylactically in anticipation of reaction to the vaccination must be recorded in the CRF with generic name of the medication (trade names are allowed for combination drugs only), total daily dose, route of administration, start and end dates of treatment and coded as ‘Prophylactic’.

Datatype

integer

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
Total daily dose
Beschrijving

Total daily dose

Datatype

integer

Alias
UMLS CUI [1]
C2826638
Route of administration
Beschrijving

Route of administration

Datatype

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Start date of medication
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C2826734
End date of medication
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C2826744
Continuation of medication
Beschrijving

Tick if medication is continuing

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0805733
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Similar models

Concomitant Medication

1 Formulieren
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Workbook number
Code List
Workbook number
CL Item
WB 1 (1)
CL Item
WB 2 (2)
CL Item
WB 3 (3)
CL Item
WB 4 (4)
Item
Visit type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Visit Day 21 (all WB's) (1)
CL Item
Visit Day 42 (WB3+4) (2)
CL Item
Visit Month 6 (all WB's) (3)
CL Item
Visit Month 6+7D (WB1+3) (4)
CL Item
Visit Month 6+21D (WB1+3) (5)
CL Item
Visit Month 12 (all WB's) (6)
CL Item
Visit Month 12+7D (WB2+4) (7)
CL Item
Visit Month 12+21D (WB2+4) (8)
CL Item
Visit Month 18 (all WB's) (9)
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Item
Have any medications/treatments been administered during the timeframe as specified by the protocol?
text
C2347852 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Administration of other vaccines
Code List
Have any medications/treatments been administered during the timeframe as specified by the protocol?
CL Item
Yes (Y)
CL Item
No (N)
Trade/ (Generic) Name
Item
Trade/ (Generic) Name
text
C0027365 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Medical Indication
integer
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medical Indication
Code List
Medical Indication
CL Item
Prophylactic (1)
Total daily dose
Item
Total daily dose
integer
C2826638 (UMLS CUI [1])
Item
Route of administration
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route of administration
Code List
Route of administration
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Other (OTH)
CL Item
Unknown (UNK)
CL Item
External (EXT)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Rectal (PR)
CL Item
Topical (TO)
CL Item
Vaginal (VA)
Start date
Item
Start date of medication
date
C2826734 (UMLS CUI [1])
End date
Item
End date of medication
date
C2826744 (UMLS CUI [1])
Continuation of medication
Item
Continuation of medication
boolean
C2347852 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
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