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])
Adverse Event
Item
Did the subject experience any adverse events during the study?
boolean
C0877248 (UMLS CUI [1])
Hematology finding, Sampling, Repeat; Chemistry, Clinical, Sampling, Repeat
Item
Were any repeat hematology or clinical chemistry samples taken?
boolean
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2,1])
C0870078 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
Urinalysis, Sampling, Repeat
Item
Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
12 lead ECG, Repeat
Item
Were any repeat/unscheduled 12-Lead ECGs performed?
boolean
C0430456 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
12 lead ECG, Abnormality
Item
Were there 12-Lead ECGs, Holter or Telemetry abnormalities recorded?
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Vital signs, Repeat
Item
Were any repeat/unscheduled vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Pharmacokinetic aspects, Sampling, Repeat
Item
Were any repeat/unscheduled PKs samples taken?
boolean
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])