Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Concomitant medication
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Serious adverse events
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Repeat haematology or clinical chemistry samples taken
Item
Were any repeat haematology or clinical chemistry samples taken?
boolean
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])
Repeat urinalysis samples
Item
Were any repeat urinalysis samples taken?
boolean
C0200345 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
Repeat ECGs
Item
Were any repeat ECGs performed?
boolean
C0013798 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Repeat vital signs
Item
Were any repeat vital signs recorded?
boolean
C0205341 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Possible suicidality-related adverse event
Item
Did the subject experience any possible suicidality-related adverse events during the study?
boolean
C0877248 (UMLS CUI [1,1])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
Liver chemistry results reached investigational product stopping criteria
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])