Subject Unblinding Event Record
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Subject Unblinding Event Record, Date in time, Time
Item
Yes, Date/time blind broken
datetime
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Yes, Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Yes, Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further investigation (1)
CL Item
Other, specify (2)
Subject Unblinding Event Record, Reason and justification
Item
Other, specify
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])