Date of visit; Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [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])
Hematology finding, Sampling, Repeat; Chemistry, Clinical, Sampling, Repeat; Urinalysis, Sampling, Repeat
Item
Were any repeat haematology, clinical chemistry, or urinalysis 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])
C0042014 (UMLS CUI [3,1])
C0870078 (UMLS CUI [3,2])
C0205341 (UMLS CUI [3,3])
Vital signs, Repeat
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Pharmacokinetic aspects, Sampling, Repeat
Item
Were any repeat PK blood samples taken?
boolean
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Serious Adverse Event, Suicide
Item
Did the subject experience any possible suicidality-related serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1,1])
C0038661 (UMLS CUI [1,2])
Dose Reduced
Item
Did the subject have a dose reduction?
text
C1707814 (UMLS CUI [1])