Adverse experiences occurence
Item
Please mark this box if no adverse experiences occurred during the book.
boolean
C1518404 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Adverse Experience
Item
Adverse Experience
text
C1518404 (UMLS CUI [1])
Onset Date and Time
Item
Onset Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
End Date and Time
Item
End Date and Time (if ongoing please leave blank)
datetime
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
CL Item
Died (If patient died, STOP: go to SAE section and follow instructions given there) (3)
Item
Experience Course
integer
C1518404 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Experience Course
Number of episodes
Item
If experience course intermittend, please fill in number of episodes
integer
C1518404 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Intensity (maximum)
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Action Taken with Respect to Investigational Drug
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
Item
Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Relationship to Investigational Drug
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
Corrective Therapy
Item
Corrective Therapy
boolean
C0087111 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Item
Was patient withdrawn due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])