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?
CL Item
Not applicable (4)
Non-serious adverse event
Item
Non-serious adverse events: Diagnosis only (if known) or signs / symptoms
text
C1518404 (UMLS CUI [1])
Start Date
Item
Start Date
text
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
CL Item
Resolved/Recovered (1)
CL Item
Resolving/Recovering (2)
CL Item
Resolved/Recovered with sequelae (4)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Not applicable (4)
Item
Action taken with investigational product(s) as a result of the non-serious AE
integer
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Investigational product(s) withdrawn (1)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 interrupted (4)
CL Item
Not applicable (6)
Item
Did subject withdraw from study as a result of this non-serious AE?
text
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Did subject withdraw from study as a result of this non-serious AE?
CL Item
Not applicable (4)
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Code List
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?