Item
Did the subject complete the study as planned?
text
C2348568 (UMLS CUI [1])
Code List
Did the subject complete the study as planned?
Item
If subject did not complete the study as planned, mark one most appropriate category
integer
C1709849 (UMLS CUI [1])
Code List
If subject did not complete the study as planned, mark one most appropriate category
CL Item
Adverse event (complete adverse event form) (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Deviation from protocol (including non-compliance) (3)
CL Item
Lost to Follow-Up (4)
Other reason
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1])
reason for withdrawal
Item
Comments on reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Date of withdrawal
Item
Date of withdrawal
date
C0011008 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Time of withdrawal
Item
Time of withdrawal
time
C0040223 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Date of final dose
Item
Date of final dose
date
C1531784 (UMLS CUI [1])
Time of final dose
Item
Time of final dose
time
C1522314 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Did subject become pregnant during the study?
text
C0549206 (UMLS CUI [1])
Code List
Did subject become pregnant during the study?
CL Item
Not applicable (Not of child bearing potential or male) (X)
Item
Did the female partner of a male subject become pregnant during the study?
text
C0549206 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
Code List
Did the female partner of a male subject become pregnant during the study?
CL Item
Not applicable (Subject is female, female partner not of childbearing potential or female partner) (X)
Adverse Event
Item
Check all Adverse Event forms are up to date and complete
boolean
C0877248 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Concomitant Medication
Item
Check that the Concomitant Medication form is up to date
boolean
C2347852 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Completion
Item
Check that all appropriate pages are signed (thus indicating completion) and dated
boolean
C0805732 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Laboratory results
Item
Check that laboratory results are included
boolean
C1254595 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])