Country No.
Item
Country No.
integer
C0454664 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Centre No.
Item
Centre No.
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Study end date
Item
Date of end of study
date
C2983670 (UMLS CUI [1])
Item
Main reason for stopping study
integer
C1542147 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Code List
Main reason for stopping study
CL Item
Completed follow-up period (1)
CL Item
Lack of efficacy (2)
CL Item
Adverse event (3)
CL Item
Poor compliance to protocol (4)
CL Item
Subject's request (5)
CL Item
Subject lost to follow-up (6)
Specify other main reason for stopping study
Item
If other main reason for stopping study, specify
text
C1521902 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
Study code broken?
Item
Was the study code broken at any time?
boolean
C3897431 (UMLS CUI [1])
Specification of study code broken
Item
If yes, specify
text
C1521902 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's signature date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])