Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study?
CL Item
Not applicable (not of childbearing potential or male) (X)
Item
Did the female partner of a male patient become pregnant during the study?
text
C0919624 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Code List
Did the female partner of a male patient become pregnant during the study?
CL Item
Not applicable (subject is female, female partner not of childbearing potential or no female partner) (X)
Item
Did the subject complete the study as planned?
text
C2983670 (UMLS CUI [1,1])
C2986196 (UMLS CUI [1,2])
Code List
Did the subject complete the study as planned?
Item
If subject did not complete the study, please mark the one most appropriate category
integer
C3827242 (UMLS CUI [1])
Code List
If subject did not complete the study, please mark the one most appropriate category
CL Item
Adverse experience (1)
CL Item
Protocol deviation (including non-compliance) (2)
CL Item
Lost to follow-up (3)
Other reason
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Comments
Item
Comments on reason for withdrawal
text
C0947611 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Date of Withdrawal
Item
Date of Withdrawal
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Withdrawal
Item
Time of Withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of Final Dose
Item
Date of Final Dose
date
C1762893 (UMLS CUI [1])
Time of Final Dose
Item
Time of Final Dose
time
C0946444 (UMLS CUI [1])