Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Onset Date and Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
End Date and Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Item
Event course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Number of episodes
Item
No. of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
Code List
Intensity (maximum)
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
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
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
patient withdrawn due to this specific AE
Item
Was patient withdrawn due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Investigator signature
Item
Investigator signature:
text
C2346576 (UMLS CUI [1])
Date
Item
Date:
date
C0011008 (UMLS CUI [1])