Follow-up study participation
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item
No, please specify the most appropriate reason
text
C3274571 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Code List
No, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events, please specify: (Adverse Events, or Serious Adverse Events, please specify:)
CL Item
Other, please specify: (Other, please specify:)
Serious adverse event
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1])
Number of serious adverse events
Item
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
C2347038 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,3])
Date of unblinding
Item
Complete date of unblinding
date
C0011008 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Item
Tick one reason below Complete Non-Serious Adverse Event section or Serious Adverse Event form as appropriate.
integer
C0566251 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Code List
Tick one reason below Complete Non-Serious Adverse Event section or Serious Adverse Event form as appropriate.
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other, specify: (9)
Elimination criteria
Item
Did any elimination criteria become applicable during the study ?
boolean
C0680251 (UMLS CUI [1])
Elimination criteria
Item
Did any elimination criteria become applicable during the study? Please specify
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Study subject participation
Item
Was the subject withdrawn from study?
boolean
C2348568 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
Item
Please tick the ONE most appropriate category for withdrawal.
text
C2349954 (UMLS CUI [1,1])
C1549995 (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) Please specify SAE N°: (SAE)
CL Item
Non-Serious adverse event (check the Non-serious Adverse Event section) Please specify unsolicited AE N° or solicited AE code : (AEX)
CL Item
Protocol violation, please specify (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: (OTH)
Item
Please tick who took decision:
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Please tick who took decision:
CL Item
Parents/Guardians (P)
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
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1705415 (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. Investigator's signature:
text
C2346576 (UMLS CUI [1])
Signature Date
Item
Date
date
C0807937 (UMLS CUI [1])
Printed Investigator's name:
Item
Printed Investigator's name:
text
C2826892 (UMLS CUI [1])