Item
Did the subject experience any non-serious adverse events during the study?
text
C0877248 (UMLS CUI [1])
Code List
Did the subject experience any non-serious adverse events during the study?
Event
Item
Event
text
C0877248 (UMLS CUI [1])
adverse event start date
Item
Start Date
date
C2697888 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Recovered / Resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / Resolved with sequelae (4)
adverse event end date
Item
End Date
date
C2697886 (UMLS CUI [1])
Item
Maximum Intensity
text
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Not applicable (X)
Item
Action taken with investigational product(s) as a result of the non-serious AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
Investigational Product(s) withdrawn (1)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this AE?
text
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Did the subject withdraw from study as a result of this AE?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?