Item
Did the subject become pregnant during the study? (Check that responses provided correspond with the sex of the subject) If `Yes`, complete Pregnancy Notification
integer
C0032961 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study? (Check that responses provided correspond with the sex of the subject) If `Yes`, complete Pregnancy Notification
CL Item
Not Applicable (not of childbearing potential or male) (3)
End Date
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Withdrawal
Item
Was the subject withdrawn from the study?
boolean
C2349954 (UMLS CUI [1])
Item
What was the primary reason for withdrawal?
integer
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Code List
What was the primary reason for withdrawal?
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropriate) (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
Sponsor terminated study (5)
CL Item
Non-compliance (6)
Withdrawal Other
Item
What was the primary reason for withdrawal? If other, specify:
text
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])