Non serious adverse event
Item
Did the subject experience any non-serious adverse events during the study? If YES, record details below.
boolean
C1518404 (UMLS CUI [1])
Non-Serious Adverse Event
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptoms e.g. Headache
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Start Date
Item
Start Date (Day Month Year) (e.g. 25 JAN 03)
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time
Item
Start time (e.g. 13:25)
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Single episode (1)
End Date
Item
End Date e.g. 27 Jan 03
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time
Item
End Time e.g. 10:20
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Frequency
integer
C3476109 (UMLS CUI [1])
CL Item
Single episode (1)
Item
Maximum Intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Single episode (1)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
integer
C1704758 (UMLS CUI [1])
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Single episode (1)
Withdrawal
Item
Withdrawal
boolean
C2349954 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Relationship to Investigational Product
Item
Relationship to Investigational Product(s) Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])