Was this subject a run-in failure?
Item
Was this subject a run-in failure?
boolean
Item
If YES, complete run-in reason
text
Code List
If YES, complete run-in reason
CL Item
Adverse event (record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate) (1)
CL Item
Protocol Deviation (2)
CL Item
Study closed/terminated (3)
CL Item
Lost to Follow-up (4)
CL Item
Investigator discretion (5)
CL Item
Withdrew consent (6)
CL Item
Did not meet continuation criteria (7)
If INVESTIGATOR DISCRETION, specify
Item
If INVESTIGATOR DISCRETION, specify
text
If WITHDREW CONSENT, specify
Item
If WITHDREW CONSENT, specify
text
Run-In Failure Date
Item
Run-In Failure Date
date