non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Diagnosis or serious signs/symptoms of NSAE
Item
Diagnosis only (if known) or signs/symptoms
text
C0011900 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Date of onset NSAE
Item
Date of onset
date
C0574845 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time of onset NSAE
Item
Time of onset
time
C0449244 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Not applicable (4)
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
CL Item
Resolved with Sequelae (2)
Date of resolution
Item
Date of resolution
date
C2985918 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time of resolution
Item
Time of resolution
time
C0040223 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Action taken with investigational product(s) as a result of the non-serious AE
integer
C0013230 (UMLS CUI [1,1])
C1608430 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
Dose adjusted (2)
CL Item
Temporarily interrupted (3)
CL Item
Permanently discontinued (4)
CL Item
Not applicable (5)
Withdrawal from study as result of NSAE
Item
Did the subject withdraw from study as a result of this non-serious AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Relationship to investigational product
Item
Is there a reasonable possibility the non-serious AE may have been caused by the investigational product(s)?
boolean
C1518404 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Definition of Seriousness
Item
Does the AE meet the definition of serious?
boolean
C1704788 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])