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Concomitant Medication

1 forms  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Cohort
Description

Cohort

Data type

integer

Alias
UMLS CUI [1]
C0599755
Visit Type
Description

Visit Type

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Have any medications/treatments been administered during the time frame as specified in the Protocol?
Description

If yes, fill in the itemgroup below for each medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1948053
UMLS CUI [1,4]
C2348563
Concomitant Medication Details
Description

Concomitant Medication Details

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C2348235
Concomitant Medication Name
Description

Generic names; trade names are allowed for combination drugs only

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Medical Indication
Description

Medical Indication

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Prophylactic Indication
Description

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 < 38.0°C or oral/axillary/ tympanic temperature <37.5 °C] and any other symptom, to prevent fever from oc curring). Any concomitant medication administered prophylactically in anticipation of reaction to the vaccination must be recorded in the eCRF 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’. It has been noted that prophylactic administration of antipyretics before or immediately after vaccine administration can reduce the incidence and intensity of post-vaccination febrile reactions. Data however suggest that the use of prophylactic paracetamol might reduce the immune response to pneumococcal vaccines. The clinical relevance of this observation remains unknown.

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0199176
Total daily dose
Description

Total daily dose

Data type

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
Administration Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Medication Start Date
Description

Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Medication End Date
Description

Medication End Date

Data type

date

Alias
UMLS CUI [1]
C2826744
continuing at end of study
Description

continuing at end of study

Data type

boolean

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C2983670
Sponsor Comment
Description

(for GSK)

Data type

text

Alias
UMLS CUI [1,1]
C2347796
UMLS CUI [1,2]
C0947611
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Similar models

Concomitant Medication

1 forms
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
HIV-pos. (1)
CL Item
HIV-neg. exposed (2)
CL Item
HIV-neg. unexposed, 3+1 schedule (3)
CL Item
HIV-neg. unexposed, 3+0 schedule (4)
CL Item
HIV-neg. unexposed, 2+1 schedule (5)
Item
Visit Type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Interim Analysis at/after Visit 6 (1)
CL Item
End of Study Analysis at/after Visit 10 (2)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant agents during protocol-specified period?
Item
Have any medications/treatments been administered during the time frame as specified in the Protocol?
boolean
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
Item Group
Concomitant Medication Details
C2347852 (UMLS CUI-1)
C2348235 (UMLS CUI-2)
Concomitant Medication Name
Item
Concomitant Medication Name
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical Indication
Code List
Medical Indication
Prophylactic Indication
Item
Prophylactic Indication
boolean
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0199176 (UMLS CUI [1,3])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Item
Administration Route
text
C0013153 (UMLS CUI [1])
Administration Route
Code List
Administration Route
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (IN)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication End Date
Item
Medication End Date
date
C2826744 (UMLS CUI [1])
continuing at end of study
Item
continuing at end of study
boolean
C1553904 (UMLS CUI [1,1])
C2983670 (UMLS CUI [1,2])
Sponsor Comment
Item
Sponsor Comment
text
C2347796 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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