Date of Final Contact
Item
Date of Final Contact
date
Date of Last Dose
Item
Date of Last Dose
date
Did subject complete the study?
Item
Did subject complete the study?
boolean
Date of discontinuation
Item
Date of discontinuation
date
Item
If subject discontinued the study, mark one reason
text
Code List
If subject discontinued the study, mark one reason
CL Item
Liver chemistry stopping criteria (record AE Number below in a corresponding line) (1)
CL Item
Adverse Event (record AE number below in a corresponding line) (2)
CL Item
Severe or repeated occurrences of hypoglycemia (record AE number below in a corresponding line) (3)
CL Item
Consent withdrawal (4)
CL Item
Lost to Follow-Up (5)
CL Item
Protocol violation (6)
CL Item
Noncompliance with study visit schedule (7)
CL Item
Termination of study by sponsor (8)
If Other, specify
Item
If Other, please specify details
text
AE Number in case of liver chemistry stopping criteria
Item
AE Number in case of liver chemistry stopping criteria
integer
AE Number in case of adverse event
Item
AE Number in case of adverse event
integer
AE Number in case of severe or repeated occurrences of hypoglycemia
Item
AE Number in case of severe or repeated occurrences of hypoglycemia
integer