Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Treatment Blind
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Item
If 'Yes' complete the following: Reason?
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
If 'Yes' complete the following: Reason?
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
Reason Treatment Blind broken
Item
If Other, please specify
text
C3897431 (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)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
subject withdrawn
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
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
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
Insufficient therapeutic effect (6)
CL Item
Did not meet treatment eligibility criteria (7)
Primary reason for withdrawal
Item
Primary reason for withdrawal. If Other, please specify
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])