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

General Information
Description

General Information

Date of Last Treatment Evaluation Through Visit 7
Description

Date of Collection

Data type

datetime

Study day of collection
Description

Study day of collection

Data type

text

Did subject complete Study Drug Treatment?
Description

Complete Study Drug Treatment

Data type

boolean

If no, please provide details below.
Description

Study Drug Treatment

Data type

text

End of Treatment
Description

End of Treatment

Data type

text

If reason is `Withdrawal by Subject` please speficy follow-up allowance
Description

Withdrawal by subject

Data type

integer

Date of Withdrawal
Description

Date of Withdrawal

Data type

date

Did AE result in death?
Description

Result in Death

Data type

text

If "Protocol Violation", please specify
Description

Protocol Violation

Data type

text

If "Other" please specify
Description

Other

Data type

text

Similar models

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
Study day of collection
Item
Study day of collection
text
Complete Study Drug Treatment
Item
Did subject complete Study Drug Treatment?
boolean
Study Drug Treatment
Item
If no, please provide details below.
text
Item
End of Treatment
text
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
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
Item
Did AE result in death?
text
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
Other
Item
If "Other" please specify
text