Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Return
Item
Return of diary card
text
C0018700 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
Item
Did the subject come at visit 3?
text
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Did the subject come at visit 3?
CL Item
Yes (Please complete the date of visit) (Yes (Please complete the date of visit))
CL Item
No (Please complete below) (No (Please complete below))
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0008972 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (OTH)
CL Item
Same reason and decision as previous visit (SAM)
Serious adverse event Number | Unsolicited Adverse Event Number | Solicited Adverse Event code
Item
Please specify SAE N°; Please specify unsolicited AE N° or solicited AE code
integer
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1])
Code List
Please tick who took the decision
CL Item
Parents/Guardians (P)