Name
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1])
Diagnosis
Item
Serious Adverse Event (Please print clearly) GSK Use
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this a serious AE. Mark all that apply.
integer
C0392360 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Specify reason(s) for considering this a serious AE. Mark all that apply.
CL Item
results in Death (1)
CL Item
life threatening (2)
CL Item
requires hospitalization or prolongation of existing hospitalization (3)
CL Item
results in disability/incapacity (4)
CL Item
congenital anomaly/birth defect (5)
CL Item
other (see definition) (6)
Specify other reason
Item
Specify other reason
text
C0392360 (UMLS CUI [1,1])
C1519255 (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 *If subject died, please inform GSK within 24 hours and complete Form D.
integer
C1705586 (UMLS CUI [1])
Code List
Outcome *If subject died, please inform GSK within 24 hours and complete Form D.
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Was subject withdrawn due to this AE?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])
SAE Abation
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
Trial medication
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
boolean
C0013227 (UMLS CUI [1])
SAE
Item
If yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1])
Item
The SAE is probably associated with:
integer
C1706737 (UMLS CUI [1])
Code List
The SAE is probably associated with:
CL Item
Protocol design or procedures (but not to study drug) (1)
CL Item
Another condition (eg, condition under study, intercurrent illness) (2)
Specify SAE
Item
Please specify
text
C0392360 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])