Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1])
Code List
Were any concomitant medications taken by the subject during the study?
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Code List
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1])
Code List
Did the subject experience any serious adverse events during the study?
Item
Were any repeat ECGs performed?
text
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Code List
Were any repeat ECGs performed?
Item
Were any repeat vital signs recorded?
text
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Code List
Were any repeat vital signs recorded?
Item
Were any repeat PK blood samples taken?
text
C0205341 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
Code List
Were any repeat PK blood samples taken?
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
text
C0023884 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
Code List
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?