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?
integer
C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008972 (UMLS CUI [1,5])
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?
integer
C1518404 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008972 (UMLS CUI [1,4])
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?
integer
C1519255 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008972 (UMLS CUI [1,4])
Code List
Did the subject experience any serious adverse events during the study?
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
integer
C0681850 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
C1832603 (UMLS CUI [1,4])
C2985739 (UMLS CUI [1,5])
Code List
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Item
Were any repeat haematology, clinical chemistry or urinalysis samples taken?
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C0042014 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
C0205341 (UMLS CUI [3,3])
Code List
Were any repeat haematology, clinical chemistry or urinalysis samples taken?
Item
Were any repeat ECGs performed?
integer
C0013798 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Code List
Were any repeat ECGs performed?
Item
Were any repeat vital signs recorded?
integer
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?
integer
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Code List
Were any repeat PK blood samples taken?
Item
Were any repeat PD samples taken?
integer
C0205341 (UMLS CUI [1,1])
C0851347 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Code List
Were any repeat PD samples taken?