Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Outcome
text
C1705586 (UMLS CUI [1])
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
Item
End Date
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Frequency
text
C0439603 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
CL Item
Single episode (1)
Item
Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C0877248 (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])
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) (1)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Item
Did the subject withdraw from study as a result of this AE?
text
C0422727 (UMLS CUI [1])
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?