Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Time of withdrawal
Item
Time of withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
subject withdrawn from the study
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If Yes, check the primary reason for withdrawal:
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
If Yes, check the primary reason for withdrawal:
CL Item
Adverse event (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Other, specify (5)
reason for withdrawal
Item
If Other reason for withdrawal, specify
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item
Did the subject become pregnant during the study?
integer
C0032961 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study?
CL Item
Not Applicable (not of childbearing potential or male) (3)
Item
Did a female partner of the male subject become pregnant during the study?
integer
C0919624 (UMLS CUI [1])
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Not applicable (subject is female, female partner not of childbearing potential or no female partner) (3)