Institution name, Identifier
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Non-serious Adverse Event
Item
Adverse Experience
text
C1518404 (UMLS CUI [1])
Non-serious Adverse Event, Start Date, Start Time
Item
Onset Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Non-serious Adverse Event, End Date, End Time
Item
End Date and Time (If ongoing please leave blank)
datetime
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Item
Experience Course
text
C1518404 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Experience Course
Non-serious Adverse Event. Course, Number of episodes
Item
No. of episodes
integer
C1518404 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
Non-serious Adverse Event, Toxicity Grade
Item
Common Toxicity Grade
integer
C1518404 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Item
Action Taken with Respect to Investigational Drug
text
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Code List
Action Taken with Respect to Investigational Drug
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Dose delayed & decreased (7)
Item
Relationship to Investigational Drug
text
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Relationship to Investigational Drug
CL Item
Suspected (reasonable possibility) (3)
Non-serious Adverse Event, Therapeutic Procedure
Item
Corrective Therapy
boolean
C1518404 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Non-serious Adverse Event, Withdraw
Item
Was patient withdrawn due to this specific AE?
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])