Serious Adverse Event (SAE)
Item
Did the subject experience a serious adverse events during the study? If YES, record details below.
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptoms e.g. Anaphylaxis
text
C1519255 (UMLS CUI [1])
Start Date
Item
Start Date (Day Month Year) (e.g. 25 JAN 03)
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time
Item
Start time (e.g. 13:25)
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
integer
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 e.g. 27 Jan 03
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time
Item
End Time e.g. 10:20
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
integer
C1704758 (UMLS CUI [1])
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
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)
Withdrawal
Item
Withdrawal Did the subject withdraw from study as a result of this SAE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to Investigational Product
Item
Relationship to Investigational Product(s) Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])