Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Code List
Was the subject withdrawn from the study?
Date of decision to withdraw
Item
Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Code List
Primary reason for withdrawal
CL Item
Adverse Event (1)
CL Item
Protocol deviation (2)
CL Item
Study closed/terminated (3)
CL Item
Lost to follow-up (4)
CL Item
investigator discretion (5)
CL Item
Withdrew consent (6)
CL Item
Lack of efficacy (7)
CL Item
Subject reached protocol-defined stopping criteria (8)
Investigator discretion
Item
If you tick in "reason for withdrawal" investigator discretion, please specify
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
Item
Case book ready for signature [hidden]
text
C1519316 (UMLS CUI [1])
Code List
Case book ready for signature [hidden]
Item
Office Use 1 [hidden)
text
C0442603 (UMLS CUI [1])
Code List
Office Use 1 [hidden)
Item
Office Use 2 [hidden]
integer
C0442603 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Code List
Office Use 2 [hidden]
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study?
Item
Did a female partner of the male subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
C0919624 (UMLS CUI [2,1])
C0086287 (UMLS CUI [2,2])
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Not Applicable (X)