Date of visit, Assessment date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Concomitant Agent
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Non-serious Adverse Event
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Serious Adverse Event
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Disease
Item
Does the subject have any past or current Medical Conditions?
boolean
C0012634 (UMLS CUI [1])
Surgical and medical procedures
Item
Has the subject had any Medical/Surgical Procedures?
boolean
C1948041 (UMLS CUI [1])
Electrocardiogram abnormal
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
C0522055 (UMLS CUI [1])
Electrocardiogram, Repeat
Item
Were any repeat ECGs performed?
boolean
C0013798 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Vital Signs, Repeat
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Pharmacokinetic study, Blood sample taken, Repeat
Item
Were any repeat PK blood samples taken?
boolean
C0201734 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Experimental drug, Dispensing medication; Experimental drug, Return
Item
Were there any Unscheduled Investigational Product dispensed or returned?
boolean
C0304229 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0332156 (UMLS CUI [2,2])
Liver Function, Chemistry, Laboratory test finding
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])