Non-Serious Adverse Events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Non-serious adverse events
Item
Non-serious adverse event: Diagnosis only (if known) or signs / symptoms (list one per line)
text
C1518404 (UMLS CUI [1])
Date of onset Non-Serious Adverse Event
Item
Date of onset Non-Serious Adverse Event
date
C2985916 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time of onset Non-Serious Adverse Event
Item
Time of onset Non-Serious Adverse Event
time
C2697889 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Toxicity Non-Serious Adverse Event
integer
C0518690 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Maximum Toxicity Non-Serious Adverse Event
CL Item
Not applicable (6)
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End date Non-Serious Adverse Event
Item
End date Non-Serious Adverse Event
date
C1518404 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
End time Non-Serious Adverse Event
Item
End time Non-Serious Adverse Event
time
C1518404 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
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
Investigationalproduct(s) withdrawn (1)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
subject withdraw from study
Item
Did 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 that the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])