Occurence or serious adverse events
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1])
Number of serious adverse events
Item
Number of serious adverse events
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Status of treatment blind
Item
Was the treatment blind broken during the study?
boolean
C2347038 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,3])
Date of break of treatment blind
Item
Date of break of treatment blind
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason for breaking treatment blind
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Reason for breaking treatment blind
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
Other reason for breaking treatment blind
Item
Other reason for breaking treatment blind, specify:
text
C3897431 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Elimination Criteria
Item
Did any elimination criteria become applicable during the study ?
boolean
C0680251 (UMLS CUI [1])
Elimination criteria, specification
Item
Elimination criteria, specify:
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Withdrawal from study
Item
Was the subject withdrawn from study?
boolean
C0422727 (UMLS CUI [1])
Item
Please tick the ONE most appropriate category for withdrawal.
text
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Please tick the ONE most appropriate category for withdrawal.
CL Item
Serious adverse event (Check Serious adverse Event form and specify SAE number below). (SAE)
CL Item
Non-serious adverse event (Check the Non-serious adverse Event section and specify unsolicited AE number or solicited AE code below) (AEX)
CL Item
protocol viloation (please specify below) (PTV)
CL Item
Consent withdrawal, not due to an adverse event. (CWS)
CL Item
migrated / moved from the study area (MIG)
CL Item
lost to follow-up (LFU)
CL Item
other (please, specify below) (OTH)
SAE number
Item
If SAE, please specify SAE number
integer
C1519255 (UMLS CUI [1,1])
C2349022 (UMLS CUI [1,2])
unsolicited AE number
Item
If unsolicited non-serious AE, please specify uncolicited AE number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])
Solicited AE code
Item
If solicited AE, please specify solicited AE code:
text
C1517001 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Protocol violation
Item
If protocol violation, please specify
text
C1709750 (UMLS CUI [1])
Other reason for withdrawal
Item
Other category, please specify:
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Please tick who took the decision:
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Please tick who took the decision:
CL Item
parents/guardians (P)
Date of last contact
Item
If withdrawn, Date of last contact
date
C0805839 (UMLS CUI [1])
Condition at last contact
Item
Was the subject in good condition at date of last contact?
boolean
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Investigator's signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below. Investigator's Signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Printed investigator's name
Item
Printed investigator's name
text
C2826892 (UMLS CUI [1])