Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Date of birth
Item
Patient date of birth
date
C0421451 (UMLS CUI [1])
Study site number
Item
Study site number
integer
C2825164 (UMLS CUI [1])
SAE number
Item
SAE number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Information on notification
Item
Date of first notification about the SAE
date
C0422202 (UMLS CUI [1,1])
C0589362 (UMLS CUI [1,2])
Information on notification
Item
Date of follow up notification about previously documented SAE (please specify number of SAE)
date
C0422202 (UMLS CUI [1,1])
C0589362 (UMLS CUI [1,2])
SAE number
Item
If you chose "Follow-up notification" please specify previously documented SAE number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Hospital Name
Item
Hospital Name/medical department
text
C2926025 (UMLS CUI [1])
Phone Number
Item
Phone number of hospital or medical department
integer
C1515258 (UMLS CUI [1])
Item
Diagnostic criteria for SAE
integer
C0679228 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Diagnostic criteria for SAE
CL Item
fatal outcome (1)
CL Item
life threatening event (2)
CL Item
lead to hospitalization or prolonged hospitalization (3)
CL Item
lead to permanent or significant disability/invalidity (4)
CL Item
congenital abnormality or birth defect (5)
CL Item
longterm artificial respiration 30 days after CABG/CAE (6)
Item
Correlation with trial procedure CABG +/- CEA
integer
C1707520 (UMLS CUI [1])
Code List
Correlation with trial procedure CABG +/- CEA
CL Item
no correlation (5)
CL Item
can not be assessed (6)
SAE diagnosis
Item
SAE diagnosis: please specify including symptoms if possible.
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
SAE Start date
Item
SAE Start date
date
C2697888 (UMLS CUI [1])
SAE End Date
Item
SAE End Date
date
C2697886 (UMLS CUI [1])
Date of death
Item
Date of death if applicable
date
C1148348 (UMLS CUI [1])
Item
Outcome of SAE
integer
C1705586 (UMLS CUI [1])
CL Item
not yet recovered (2)
CL Item
recovered with sequelae (4)
Cause of death
Item
Cause of death if SAE was fatal
text
C0007465 (UMLS CUI [1])
Date of completion
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature by investigator
text
C1519316 (UMLS CUI [1])
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI [1])