Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Start date
Item
Start date of adverse event
date
C0808070 (UMLS CUI [1])
Serious Adverse Event
Item
Serious Adverse Event
boolean
C1519255 (UMLS CUI [1])
Item
Intensity
text
C0518690 (UMLS CUI [1])
CL Item
slight, no effect on daily activities (e.g, cooking, shopping) (1)
CL Item
moderate, daily activity impaired (2)
CL Item
severe, daily activity not possible (3)
Item
Relation to study medication
text
C0013227 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0869014 (UMLS CUI [2])
Code List
Relation to study medication
CL Item
no reasonable connection (1)
CL Item
reasonable connection (2)
Item
Measures taken regarding study medication
text
C0013227 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0079809 (UMLS CUI [1,3])
Code List
Measures taken regarding study medication
CL Item
dose reduction (2)
CL Item
dose increase (3)
CL Item
temporarily stopped (4)
CL Item
ultimately stopped (5)
CL Item
not applicable (7)
Adverse Event Caused Study Discontinuation
Item
Adverse event leading to study discontinuation
boolean
C2826233 (UMLS CUI [1])
Adverse Event End Date
Item
Adverse event end date
date
C2697886 (UMLS CUI [1])
Item
Adverse Event Outcome
text
C1705586 (UMLS CUI [1])
Code List
Adverse Event Outcome
CL Item
still not improved (3)
CL Item
restored with permanent damage (4)