Item
Would the subject be willing to participate in a follow-up study?
integer
C2348568 (UMLS CUI [1])
Code List
Would the subject be willing to participate in a follow-up study?
CL Item
No, please specify the reason (2)
participation status study subject adverse event
Item
Adverse Events, or Serious Adverse Events:
boolean
C2348568 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
participation status study subject adverse event specify
Item
please specify
text
C2348568 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
participation status study subject other reason
Item
Other
boolean
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
participation status study subject specify other reason
Item
please specify:
text
C2348568 (UMLS CUI [1,1])
C0566251 (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)
Item
Did any elimination criteria become applicable during the study?
integer
C0680251 (UMLS CUI [1])
Code List
Did any elimination criteria become applicable during the study?
CL Item
Yes, please specify (2)
specify elimination criteria
Item
please specify
text
C0680251 (UMLS CUI [1])
Item
Has the subject dropped out of the study?
integer
C2348568 (UMLS CUI [1])
Code List
Has the subject dropped out of the study?
CL Item
Yes, (SAE) Serious adverse event (complete the Serious Adverse Event form). (2)
CL Item
Yes, (AEX) Non-Serious adverse event (complete the Non-serious Adverse Event form). (3)
CL Item
Yes, (PTV) Protocol violation, please specify: (4)
CL Item
Yes, (CWS) Consent withdrawal, not due to an adverse event. (5)
CL Item
Yes, (MIG) Migrated / moved from the study area (6)
CL Item
Yes, (LFU) Lost to follow-up. (7)
CL Item
Yes, (OTH) Other, please specify: (8)
drop out NAE
Item
If Non-Serious adverse Event, please specify AE N°:
text
C2348568 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
drop out protocol violation
Item
If Protocol violation, please specify:
text
C2348568 (UMLS CUI [1,1])
C1709750 (UMLS CUI [1,2])
drop out other reason
Item
If Other, please specify:
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
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?
integer
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Code List
Was the subject in good condition at date of last contact?
CL Item
No, please give details within the Adverse Events section (1)