follow-up study
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1])
Item
No, please specify the most appropriate reason
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
No, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events (1)
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1])
number of SAEs
Item
If Yes, Specify total number of SAE's:
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
treatment blind
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
treatment blind broken date
Item
treatment blind broken date
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
reason treatment blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
reason treatment blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
reason treatment blind broken
Item
reason treatment blind broken. If Other, please specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
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 ? If Yes, please specify
text
C0680251 (UMLS CUI [1])
subject withdrawn from study
Item
Was the subject withdrawn from study?
boolean
C0422727 (UMLS CUI [1])
Item
If Yes, Please tick the ONE most appropriate category for withdrawal.
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
If Yes, Please tick the ONE most appropriate category for withdrawal.
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Protocol violation (3)
CL Item
Consent withdrawal, not due to an adverse event (4)
CL Item
Migrated / moved from the study area (5)
CL Item
Lost to follow-up (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
Parents/Guardians (2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
subject condition
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
Investigator's signature
text
C2346576 (UMLS CUI [1])