Center ID
Item
ID of Center
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient ID
Item
ID of Patient
text
C2348585 (UMLS CUI [1])
Adverse Event Number
Item
Number of current Adverse Event:
float
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Adverse Event Diagnosis
Item
Adverse Event Diagnosis specify diagnosis if known, otherwise symptoms:
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Max. intensity:
text
C0522510 (UMLS CUI [1])
Code List
Max. intensity:
CL Item
life-threatening (4)
CL Item
death realted to AE (5)
Therapy of adverse event
Item
Therapy of adverse event
boolean
C0087111 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Therapy of adverse event: specification
Item
Therapy of adverse event: If "yes", please comment:
text
C0087111 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Outcome of event:
text
C1705586 (UMLS CUI [1])
Code List
Outcome of event:
CL Item
not recovered (3)
CL Item
recovered with sequel (4)
Serious adverse event
Item
Serious adverse event?
boolean
C2985919 (UMLS CUI [1])
Item
Why was this event serious?
text
C2985919 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
Why was this event serious?
CL Item
hospitalisation (3)
CL Item
medically important condition (6)
Serious adverse event: specification
Item
Serious adverse event? If "yes", please verify immedietly, if SAE reporting is necessary according to protocol.
text
C2985919 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
SAE report
Item
If serious, SAE report necessary according to protocol?
boolean
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
Item
Causal relationship with regional citrate anticoagulation
text
C0974442 (UMLS CUI [1])
Code List
Causal relationship with regional citrate anticoagulation
Item
Action taken with regional citrate anticoagulation due to event
text
C0441472 (UMLS CUI [1,1])
C0974442 (UMLS CUI [1,2])
Code List
Action taken with regional citrate anticoagulation due to event
CL Item
no action taken (0)
CL Item
therapy interrupted (1)
CL Item
therapy discontinued (2)
Item
Causal relationship with Renal Replacement Therapy
text
C0206074 (UMLS CUI [1])
Code List
Causal relationship with Renal Replacement Therapy
Comment
Item
Comment (please refer to AE No.):
text
C0947611 (UMLS CUI [1])
Case report form date
Item
Date of confirmation of CRF:
date
C1516308 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Doctor's Name
Item
Name of authorized trial physician:
text
C0027365 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Doctor's signature
Item
Signature of authorized trial physician:
text
C1519316 (UMLS CUI [1])