Item
End of treatment
integer
C0087111 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
Code List
End of treatment
CL Item
regular termination of treatment (V6) (1)
CL Item
premature termination of treatment (2)
Study medication end date
Item
Date of last intake
date
C1521826 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Premature termination of treatment by:
integer
C0087111 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Code List
Premature termination of treatment by:
Item
Reason
integer
C0087111 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C3166257 (UMLS CUI [1,3])
CL Item
Hepatotoxicity (3)
CL Item
other (specify) (4)
premature treatment termination specify
Item
Specify other reason for premature treatment termination
text
C0871548 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
End of study
integer
C0444496 (UMLS CUI [1])
CL Item
regular termination after last visit (Visit 7) (1)
CL Item
premature termination (2)
Date of end of study
Item
Date
date
C2983670 (UMLS CUI [1])
Item
Last regular visit/interview
integer
C0545082 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
Code List
Last regular visit/interview
Item
Premature termination of study by:
integer
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Premature termination of study by:
Withdrawal of informed consent
Item
Withdrawal of informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1710677 (UMLS CUI [1,2])
Date of withdrawal of consent
Item
Date of withdrawal of consent
date
C2349954 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
adverse event or serious adverse event
Item
AE/SAE
boolean
C0877248 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
AE code
Item
AE number according to AE report form
text
C0877248 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Death of patient
Item
Death
boolean
C0011065 (UMLS CUI [1])
Date of death
Item
Date
date
C1148348 (UMLS CUI [1])
Cause of death
Item
Cause of death
text
C0007465 (UMLS CUI [1])
Eligibilty criteria
Item
Patient did not meet Inclusion/Exclusion Criteria.
boolean
C0013893 (UMLS CUI [1])
Pregnancy
Item
Pregnancy
boolean
C0032961 (UMLS CUI [1])
Compliance
Item
Patient's non-compliance
boolean
C1321605 (UMLS CUI [1])
protocol violation
Item
Significant protocol violations
boolean
C1709750 (UMLS CUI [1])
protocol violations
Item
Significant protocol violations
text
C1709750 (UMLS CUI [1])
Lost to follow-up
Item
Lost to follow-up
boolean
C1302313 (UMLS CUI [1])
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Lost to follow-up reason
Item
Reason
text
C1302313 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
premature termination other reason
Item
other (please specify)
text
C2718058 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Unblinding
Item
Unblinding (independent from regular or premature study termination)
boolean
C3897431 (UMLS CUI [1])
Unblinding date
Item
Date
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Unblinding Specification
Item
Specification
text
C3897431 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Investigator Signature Date
Item
Date of Investigator Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Name of investigator
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])