Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
date
Item
Date on which adverse event began
date
C0011008 (UMLS CUI [1])
Item
Is it a systemic reaction? (based on SLIT)
text
C1710276 (UMLS CUI [1])
Code List
Is it a systemic reaction? (based on SLIT)
CL Item
nonspecific symptoms (e.g. headache, apprehension) (1)
CL Item
slight specific symptoms (local urticaria, rhinitis or slight asthma (PEF<20%)) (2)
CL Item
medium specific symptoms (slow onset of (> 15 min) of urticaria and/ or medium asthma (PEF < 40%)) (3)
CL Item
serious (not life threatening) systemic symptoms (rapid onset (< 15min) of urticaria, Angioedema or serious asthma (PEF > 40%)) (4)
CL Item
anaphylactic shock (please document additionally as SAE) (5)
CL Item
not applicable (6)
Item
Relation to medication
text
C0013227 (UMLS CUI [1])
Code List
Relation to medication
CL Item
may be related (2)
Item
Frequency of adverse event
text
C0439603 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Frequency of adverse event
Item
Seriousness of adverse event
text
C0871902 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Seriousness of adverse event
Item
Course of adverse event
text
C0750729 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Course of adverse event
CL Item
finished/ resulting in additional symptoms (4)
Item
Measures related to study medication
text
C0013227 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Code List
Measures related to study medication
CL Item
dose adjustment (2)
CL Item
second interruption of therapy (3)
CL Item
discontinuation of therapy (4)
Item
Other taken measures
text
C2347852 (UMLS CUI [1])
C0019994 (UMLS CUI [2])
Code List
Other taken measures
CL Item
change of concomitant medication (2)
CL Item
hospitalization/ extension of a hospital stay (3)
CL Item
additional therapeutic or diagnostic measure (4)
date
Item
Date on which adverse event ended
date
C0011008 (UMLS CUI [1])
ongoing adverse event
Item
Ongoing of adverse event (beyond V7)?
boolean
C0549178 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])