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Concomitant Vaccination, Concomitant Medication

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Workbook Number
Description

Workbook Number

Data type

integer

Alias
UMLS CUI [1]
C2986015
Concomitant Vaccination
Description

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Description

If you tick yes, please record concomitant vaccination with trade name and / or generic name, route and vaccine administration date.

Data type

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Trade / Generic Name of vaccine
Description

Trade / Generic Name of vaccine

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0042210
Route of vaccine administration
Description

Route of vaccine administration

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration date of concomitant vaccine
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
Comment for GSK
Description

Comment for GSK

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0013227
Have any medications/treatments been administered during study period?
Description

All concomitant medication, with the exception of vitamins and/or dietary supplements, administered at ANY time during the period starting with administration of each dose of study vaccine and ending one month (minimum 30 days) after each dose of study vaccine are to be recorded with generic name of the medication (trade names are allowed for combination drugs, i.e. multi-component drugs), medical indication, total daily dose, route of administration, start and end dates of treatment. Any treatments and/or medications specifically contraindicated, e.g., any immunoglobulins, other blood products and any immune modifying drugs administered since birth or at any time during the active phase of the study are to be recorded with generic name of the medication (trade names are allowed for combination drugs only), medical indication, total daily dose, route of administration, start and end dates of treatment.

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2347852
Trade / Generic Name of medication
Description

Trade / Generic Name of medication

Data type

text

Alias
UMLS CUI [1]
C2360065
Medical indication of concomitant medication
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] 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 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’.

Data type

integer

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
If other medical indication of concomitant medication, please specify
Description

Other medical indication

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0013227
Total daily dose
Description

Total daily dose

Data type

text

Alias
UMLS CUI [1]
C2826638
Route of medication administration
Description

Route of medication administration

Data type

text

Alias
UMLS CUI [1]
C0013153
Start date of concomitant medication
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2826734
End date of concomitant medication
Description

day month year. Or check box below, if continuing

Data type

date

Alias
UMLS CUI [1]
C2826744
Tick if concomitant medication continuing
Description

Concomitant medication, continious

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Comment for GSK
Description

Comment for GSK

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961
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Similar models

Concomitant Vaccination, Concomitant Medication

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
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)
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
text
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant vaccination
Code List
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
CL Item
No (N)
CL Item
Yes (Y)
Trade / Generic Name of vaccine
Item
Trade / Generic Name of vaccine
text
C2360065 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Route of vaccine administration
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route of vaccine administration
Code List
Route of vaccine administration
CL Item
Intradermal  (ID)
CL Item
Parenteral (PE)
CL Item
Inhalation  (IH)
CL Item
Oral (PO)
CL Item
Intramuscular  (IM)
CL Item
Subcutaneous (SC)
CL Item
Intravenous  (IV)
CL Item
Sublingual (SL)
CL Item
Intranasal  (NA)
CL Item
Transdermal (TD)
CL Item
Other  (OTH)
CL Item
Unknown (UNK)
Administration date of concomitant vaccine
Item
Administration date of concomitant vaccine
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Comment for GSK
Item
Comment for GSK
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Item
Have any medications/treatments been administered during study period?
text
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant medication
Code List
Have any medications/treatments been administered during study period?
CL Item
No (N)
CL Item
Yes (Y)
Trade / Generic Name of medication
Item
Trade / Generic Name of medication
text
C2360065 (UMLS CUI [1])
Item
Medical indication of concomitant medication
integer
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical indication
Code List
Medical indication of concomitant medication
CL Item
Prophylactic (1)
Other medical indication
Item
If other medical indication of concomitant medication, please specify
text
C0205394 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Total daily dose
Item
Total daily dose
text
C2826638 (UMLS CUI [1])
Item
Route of medication administration
text
C0013153 (UMLS CUI [1])
Route of medication administration
Code List
Route of medication administration
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 (NA)
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)
Start date of concomitant medication
Item
Start date of concomitant medication
date
C2826734 (UMLS CUI [1])
End date of concomitant medication
Item
End date of concomitant medication
date
C2826744 (UMLS CUI [1])
Concomitant medication, continious
Item
Tick if concomitant medication continuing
boolean
C2826666 (UMLS CUI [1])
Comment for GSK
Item
Comment for GSK
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
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