Item
Was the treatment blind broken during the study?
text
C3897431 (UMLS CUI [1])
Code List
Was the treatment blind broken during the study?
Date blind broken
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time blind broken
Item
Time blind broken
time
C3897431 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
Other Reason blind broken
Item
If other reason blind broken, please specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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Was the subject withdrawn from the study?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Was the subject withdrawn from the study?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])
C0392360 (UMLS CUI [1,2])
Code List
Primary reason for withdrawal
CL Item
Adverse Event (1)
CL Item
Protocol deviation (2)
CL Item
Subject reached protocol defined stopping criteria (3)
CL Item
Study closed/terminated (4)
CL Item
Lost to Follow-up (5)
CL Item
Investigator discretion (6)
CL Item
Withdrew consent (7)
Reason for withdrawal, Investigator discretion, specification
Item
If Investigator discretion for subject's withdrawal, please specify
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Case book ready for signature
Item
Case book ready for signature
boolean
C1706256 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Item
Office Use 1
text
C0008976 (UMLS CUI [1,1])
C1707478 (UMLS CUI [1,2])
C0442603 (UMLS CUI [1,3])
C1524063 (UMLS CUI [1,4])
Item
Office Use 2
integer
C0008976 (UMLS CUI [1,1])
C1707478 (UMLS CUI [1,2])
C0442603 (UMLS CUI [1,3])
C1524063 (UMLS CUI [1,4])
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
C0086287 (UMLS CUI [1,1])
C3887537 (UMLS CUI [1,2])
C3828490 (UMLS CUI [1,3])
Code List
Did a female partner of the male subject become pregnant during the study?