Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
non-serious adverse event
Item
Did the subject experience a non-serious adverse event during the study?
boolean
C1518404 (UMLS CUI [1])
Non-serious Adverse Event
Item
Non-serious Adverse Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C1518404 (UMLS CUI [1])
Onset Date
Item
Onset Date
date
C1518404 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
End Date
Item
End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Outcome
integer
C1624730 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal, record Date of Death (5)
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Item
Intensity (maximum)
integer
C0518690 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Intensity (maximum)
Item
Action Taken with Respect to Investigational Drug
integer
C1547656 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Action Taken with Respect to Investigational Drug
CL Item
lnvestigational product(s) withdrawn (1)
CL Item
Dose not changed (2)
CL Item
Dose interrupted (3)
CL Item
Not applicable (4)
Relationship investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])