Was this subject a run-in failure?
Item
Was this subject a run-in failure?
boolean
C1710476 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Item
If YES, complete run-in reason
text
C1710476 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
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
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
If WITHDREW CONSENT, specify
Item
If WITHDREW CONSENT, specify
text
C1707492 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Run-In Failure Date
Item
Run-In Failure Date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])