Any Adverse Event
Item
Was any adverse event reported or observed?
boolean
C0877248 (UMLS CUI [1])
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Onset Date
Item
Onset Date
date
C0877248 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Outcome
text
C1705586 (UMLS CUI [1])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not Resolved (3)
CL Item
Recovered/Resolved with Sequelae (4)
Item
Course of Event
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Course of Event
CL Item
Single Episode (1)
Item
Severity
text
C1710066 (UMLS CUI [1])
Serious AE
Item
Serious AE?
boolean
C1519255 (UMLS CUI [1])
Serious AE Number
Item
Serious AE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Death
Item
Death
boolean
C1705232 (UMLS CUI [1])
Requires or prolongs hospitalization
Item
Requires or prolongs hospitalization
boolean
C0877248 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Congenital anomaly
Item
Congenital anomaly
boolean
C2826727 (UMLS CUI [1])
Life-threatening
Item
Life-threatening
boolean
C1517874 (UMLS CUI [1])
Disability
Item
Persistent or significant disability/incapacity
boolean
C0877248 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Medical Importance
Item
Other medical importance
boolean
Item
Action Taken for Study Drug
text
C2826626 (UMLS CUI [1])
Code List
Action Taken for Study Drug
CL Item
Dose Not Changed (1)
CL Item
Drug Interrupted (2)
CL Item
Drug Withdrawn (3)
CL Item
Not Applicable (4)
Treatment
Item
Was there any treatment required?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Medication Therapy
Item
Medication Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Non-Medication Therapy
Item
Non-Medication Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item
Relationship to Study Drug
text
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Code List
Relationship to Study Drug