Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Code List
Did the subject experience any non-serious adverse events during the study?
diagnosis or signs/symptoms
Item
Diagnosis or signs/symptoms
text
C0011900 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
date and time of onset of adverse event
Item
Date and time of onset
datetime
C0332162 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1717740 (UMLS CUI [1,3])
Item
Maximum intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Maximum intensity
Item
Event course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Item
Outcome
text
C1705586 (UMLS CUI [1])
date and time of resolution
Item
Date and time of resolution
datetime
C1717740 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
Item
Action taken with study drug(s) as a result of the non-serious AE
integer
C0580105 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2])
Code List
Action taken with study drug(s) as a result of the non-serious AE
CL Item
Dose increased (2)
CL Item
Drug interrupted/restarted (3)
Item
Withdrawal
text
C0422727 (UMLS CUI [1])
Item
Relationship to study drug(s)
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Relationship to study drug(s)
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
Item
Corrective therapy
text
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Code List
Corrective therapy