Adverse Event
Item
Did Adverse Events occur?
boolean
C0877248 (UMLS CUI [1])
Adverse Event
Item
Adverse Event:
text
C0877248 (UMLS CUI [1])
Adverse Event Start Date Time
Item
Adverse Event Start Date Time
datetime
C2826806 (UMLS CUI [1])
Adverse Event End Date Time
Item
Adverse Event End Date Time
datetime
C2826793 (UMLS CUI [1])
Serious adverse event
Item
Serious adverse event, SAE
text
C1519255 (UMLS CUI [1])
Item
Connection with intervention
text
C0184661 (UMLS CUI [1])
Code List
Connection with intervention
CL Item
no connection (1)
CL Item
connection exists (2)
Item
Degree of severity
text
C1710066 (UMLS CUI [1])
Code List
Degree of severity
CL Item
life-threatening (4 )
CL Item
fatal (death) (5 )
Item
Measures taken regarding adverse event
text
C1608430 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
Code List
Measures taken regarding adverse event
CL Item
dose reduction (2 )
CL Item
dose increase (3 )
CL Item
drug interrupted (4 )
CL Item
drug discontinued (5 )
CL Item
adjunctive therapy (6 )
Item
Adverse Event outcome
text
C1705586 (UMLS CUI [1])
Code List
Adverse Event outcome
CL Item
recovered with consequential damages (2 )