Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item
AE No.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-Serious Adverse Event, Description
Item
Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Description
text
C1518404 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
CL Item
Administration sites (1)
CL Item
Non-administration sites (2)
Item
If Administrazion site, Vaccine
text
C1518404 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Code List
If Administrazion site, Vaccine
CL Item
Hib-MenCY-TT vaccine (1)
CL Item
Infanrix® penta vaccine (2)
CL Item
Prevenar® vaccine (3)
CL Item
ActHIB® vaccine (4)
CL Item
Meningitec® vaccine (5)
Non-Serious Adverse Event, Chronic disease
Item
Please check box in case of onset of chronic illness
boolean
C1518404 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
Non-Serious Adverse Event, Start Date
Item
Date started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-Serious Adverse Event, End Date
Item
Date stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Non-Serious Adverse Event, Relationship, Experimental drug
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
CL Item
Recovered / Resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / Resolved with sequelae (4)
Non-Serious Adverse Event, Visit, advice, medical
Item
Medically attended visit (Refer to protocol for full definition.) If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
boolean
C1518404 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Non-Serious Adverse Event, Visit, advice, medical, Type
Item
Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
boolean
C1518404 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])