Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Continuation status, Clinical Trials
Item
Did the subject come at visit 3?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Same reason and decision as previous visit. (1)
CL Item
Serious adverse event (Please specify SAE N°) (2)
CL Item
Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (3)
CL Item
Other, please specify (e.g. consent withdrawal, Protocol violation, ...) (4)
Item
Specify
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item
Please tick who took the decision
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Code List
Please tick who took the decision
CL Item
Parents/Guardians (2)
Collection of blood specimen for laboratory procedure, Post-vaccination precautions
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1,1])
C1443955 (UMLS CUI [1,2])
Collection of blood specimen for laboratory procedure, Post-vaccination precautions, Date in time
Item
Please complete only if different from visit date
date
C0005834 (UMLS CUI [1,1])
C1443955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Gastroenteritis
Item
Did the subject present Gastroenteritis anytime starting from day 8 after dose 2 until visit 3?
boolean
C0017160 (UMLS CUI [1])