Center ID
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Study Continuation
Item
Did the subject come at visit 2?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Did the subject not come at visit 2?
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Did the subject not come at visit 2?
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
C1519255 (UMLS CUI-1)
(Comment:en)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
C1518404 (UMLS CUI-1)
(Comment:en)
CL Item
Other, please specify (OTH)
C0205394 (UMLS CUI-1)
C2368628 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
C1272696 (UMLS CUI-4)
(Comment:en)
Serious adverse event
Item
If SAE, please specify SAE N°
integer
C1519255 (UMLS CUI [1])
Non-serious adverse event
Item
If AEX, please specify AE N° (Unsol.) or code (Solicited)
integer
C1518404 (UMLS CUI [1])
Other reason for non-administration
Item
If other, please specify
text
C0205394 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
Item
Who took the decision?
text
C0679006 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1548562 (UMLS CUI [1,3])
Code List
Who took the decision?
CL Item
Investigator (I)
C0008961 (UMLS CUI-1)
(Comment:en)
CL Item
Parents/Guardians (P)
C0030551 (UMLS CUI-1)
C0023226 (UMLS CUI-3)
(Comment:en)
blood sample
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1])
date of blood sample
Item
Date of blood sample only if different from visit date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])