Non-serious adverse event
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
Event
Item
Event
text
C1518404 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Start Date and Time
Item
Start Date and Time
datetime
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C1518404 (UMLS CUI [2,2])
Item
Outcome
integer
C1518404 (UMLS CUI [1,1])
C1274040 (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 and Time
Item
End Date and Time
datetime
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C1518404 (UMLS CUI [2,2])
Item
Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
CL Item
Single episode (1)
Item
Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C1522410 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
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
C1547656 (UMLS CUI [1,1])
C4688482 (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
Investigational product(s) withdrawn (1)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)
Withdrawal
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1547656 (UMLS CUI [1,1])
C1710677 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Relationship to Investigational Product(s)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0332149 (UMLS CUI [1,1])
C4688482 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])