End of Study: End of Treatment/ Premature Discontinuation [DS_1] NCT01117584

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
Date of Collection
Item
Date of Last Treatment Evaluation Through Visit 7
datetime
C0557980 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Study day of collection
Item
Study day of collection
text
C0557980 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,3])
Complete Study Drug Treatment
Item
Did subject complete Study Drug Treatment?
boolean
C0008972 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Study Drug Treatment
Item
If no, please provide details below.
text
C0008972 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item
End of Treatment
text
C0087111 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
Code List
End of Treatment
CL Item
Not fulfill inclusion or exclusion criteria  (1)
CL Item
Adverse event (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal by subject (4)
CL Item
Subject lost to follow-up (5)
CL Item
Protocol violation (6)
CL Item
Randomized/registered but never received/dispensed study drug (7)
CL Item
Other (8)
Item
If reason is `Withdrawal by Subject` please speficy follow-up allowance
integer
C0589120 (UMLS CUI [1])
Code List
If reason is `Withdrawal by Subject` please speficy follow-up allowance
CL Item
Allows follow-up after withdrawal (1)
CL Item
Does not allow follow-up after withdrawal (2)
Date of Withdrawal
Item
Date of Withdrawal
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Did AE result in death?
text
C1705232 (UMLS CUI [1])
Code List
Did AE result in death?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Protocol Violation
Item
If "Protocol Violation", please specify
text
C1709750 (UMLS CUI [1])
Other
Item
If "Other" please specify
text

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