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. Headache
text
C151925 (UMLS CUI [1])
Start Date
Item
Start Date (Day Month Year) (e.g. 25 JAN 03)
date
C0808070 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Single episode (1)
End Date
Item
End Date e.g. 27 Jan 03
date
C0806020 (UMLS CUI [1])
Item
Frequency
integer
C3476109 (UMLS CUI [1])
CL Item
Single episode (1)
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (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])
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
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Fatal
Item
If fatal, was a post-mortem/autopsy performed? If yes, summaries findings in Section 11 Narrative Remarks of this SAE form.
boolean
C1705586 (UMLS CUI [1])
Item
Specify reson(s) for considering this a SAE, check all that apply:
integer
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
Specify reson(s) for considering this a SAE, check all that apply:
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalization (3)
CL Item
Results in disability/incapicity (4)
CL Item
Congenital abnormality/birth defect (5)
Specification other
Item
Specify other:
text
C2348235 (UMLS CUI [1])