Adverse event number
Item
Adverse event number
integer
C0877248 (UMLS CUI [1])
Adverse event
Item
Adverse event:
text
C0877248 (UMLS CUI [1])
Adverse event starting date
Item
Adverse event starting date
date
C0877248 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Severe adverse event?
integer
C0877248 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Code List
Severe adverse event?
CL Item
Yes, severe adverse event documented (1)
CL Item
Yes, but due to protocol 10.2 no severe adverse event documentation necessary (2)
Item
Measures taken regarding investigational agent
integer
C0013227 (UMLS CUI [1,1])
C0079809 (UMLS CUI [1,2])
Code List
Measures taken regarding investigational agent
CL Item
No change of dose (1)
CL Item
Medication momentarily stopped (2)
CL Item
Medication definitely stopped (3)
CL Item
Not applicable (5)
Adverse event leads to study termination
Item
Does the adverse event lead to study termination?
boolean
C0877248 (UMLS CUI [1,1])
C2348581 (UMLS CUI [1,2])
Item
Connection between adverse event and investigational agent
integer
C1875319 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0449379 (UMLS CUI [1,3])
Code List
Connection between adverse event and investigational agent
CL Item
no suspicion of there being a connection between adverse event and investigational agent (1)
CL Item
suspicion of there being a connection between adverse event and investigational agent (2)
Item
intensitiy of the adverse event
integer
C0522510 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
intensitiy of the adverse event
CL Item
light (activities of daily living are not affected) (1)
CL Item
medium (activities of daily living are affected) (2)
CL Item
severe (activities of daily living or work is impossible) (3)
end date of adverse event
Item
end date of adverse event
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Adverse event still ongoing at transferal
Item
Adverse event still ongoing at transferal
boolean
C0877248 (UMLS CUI [1,1])
C0030704 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Item
Outcome of the adverse event
integer
C1705586 (UMLS CUI [1])
Code List
Outcome of the adverse event
CL Item
not improved yet (3)
CL Item
restored with damage (4)
Any further adverse event subject to documentation
Item
Any further adverse event subject to documentation
boolean
C0877248 (UMLS CUI [1])