Diagnosis
Item
Adverse Event GSK Use
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Onset Date/Time
Item
Onset Date/Time
datetime
C2985916 (UMLS CUI [1])
End Date/Time
Item
End Date/Time (if ongoing, please leave blank)
datetime
C3899266 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Item
Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C0522510 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Intensity (maximum)
Item
Action taken with Respect to Investigational Drug
integer
C0441472 (UMLS CUI [1,1])
C0013230 (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
C0013230 (UMLS CUI [1])
Code List
Relationship to Investigational Drug
CL Item
Suspected (reasonable possibility) (3)
Corrective Therapy
Item
Corrective Therapy If ´Yes`, Please record on Concomitant Medication form.
boolean
C0087111 (UMLS CUI [1])
Withdrawal
Item
Was subject withdrawn due to this AE?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])