follow-up study
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
reason for non participation
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
reason for non participation
CL Item
Adverse Events, or Serious Adverse Events (1)
reason for non participation
Item
Reason for non participation: Adverse Events, or Serious Adverse Events, please specify
text
C0877248 (UMLS CUI [1])
C0558080 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
reason for non participation
Item
Reason for non participation: Other, please specify
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
exclusion criteria
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
exclusion criteria
Item
Did any elimination criteria become applicable during the study? If Yes, please specify
text
C0680251 (UMLS CUI [1])
study drop out
Item
Has the subject dropped out of the study?
boolean
C2348568 (UMLS CUI [1])
Item
Has the subject dropped out of the study? If Yes, please mark the ONE most appropriate category for drop out.
integer
C1444662 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Code List
Has the subject dropped out of the study? If Yes, please mark the ONE most appropriate category for drop out.
CL Item
Serious adverse event (complete the Serious Adverse Event form). (1)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event form). (2)
CL Item
Protocol violation, please specify (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)
CL Item
Other, please specify (7)
AE Number
Item
If Non-Serious adverse event, Please specify AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1444662 (UMLS CUI [2,1])
C0392360 (UMLS CUI [2,2])
Protocol violation,
Item
If Protocol violation, please specify
text
C1709750 (UMLS CUI [1])
C1444662 (UMLS CUI [2,1])
C0392360 (UMLS CUI [2,2])
reason for study drop out
Item
If Other, please specify
text
C1444662 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Date of last contact
Item
Date of last contact
date
C1705415 (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])
Item
Has the subject become pregnant during the study?
integer
C0032961 (UMLS CUI [1])
Code List
Has the subject become pregnant during the study?
CL Item
Yes, please complete the Pregnancy Report Form. (2)