Serious adverse event
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1])
Total number of SAE's
Item
If you answered the previous question with Yes → Specify total number of SAE's:
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Treatment blind
Item
Was the treatment blind broken during the study?
boolean
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Treatment blind broken date
Item
If you answered the previous question with Yes → Complete date and tick one reason below.
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If you answered the previous question with Yes Complete date and tick one reason below.
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
If you answered the previous question with Yes Complete date and tick one reason below.
CL Item
[1] Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
[2] Other, specify: _______________________________________________ (2)
Item
Did any elimination criteria become applicable during the study?
integer
Code List
Did any elimination criteria become applicable during the study?
CL Item
Yes → Specify: __________________________________________________________ (2)
Subject withdrawal
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If you answered the previous question with Yes → Please tick the ONE most appropriate category for withdrawal.
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
If you answered the previous question with Yes → Please tick the ONE most appropriate category for withdrawal.
CL Item
[SAE] Serious adverse event (check Serious Adverse Event form) Please specify SAE N°: |__|__| (1)
CL Item
[PTV] Protocol violation, please specify: ________________________________ (2)
CL Item
[CWS] Consent withdrawal, not due to an adverse event. (3)
CL Item
[MIG] Migrated / moved from the study area (4)
CL Item
[LFU] Lost to follow-up. (5)
CL Item
[OTH] Other, please specify: _______________________________________ (6)
Item
Please tick who took decision:
integer
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Please tick who took decision:
CL Item
[I] Investigator (1)
CL Item
[P] Parents/Guardians (2)
Date of last contact
Item
Date of last contact:
date
C0805839 (UMLS CUI [1])
Item
Was the subject in good condition at date of last contact?
text
C0805839 (UMLS CUI [1,1])
C1142435 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
Code List
Was the subject in good condition at date of last contact?
CL Item
No, please give details within the Adverse Events section. (No, please give details within the Adverse Events section.)
Investigators 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.
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Investigator signature date
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])
