Person Reporting SAE
Item
Person Reporting SAE
text
AEGIS Number
Item
AEGIS Number
integer
Serious Adverse Experience
Item
Serious Adverse Experience
text
Item
Reasons for considering a serious AE
text
Code List
Reasons for considering a serious AE
CL Item
results in death (1)
CL Item
life threatening (2)
CL Item
results in hospitalization or prolongation of existing hospitalization (3)
CL Item
Results in disability/incapacity (4)
CL Item
congenital abnormality/birth defect (5)
CL Item
Other (please specify below) (6)
Specification of other reason for considering a serious AE
Item
Specification of other reason for considering a serious AE
text
Onset Date and Time
Item
Onset Date and Time
datetime
End Date and Time
Item
End Date and Time (if ongoing please leave blank)
datetime
Item
Experience Course
text
Code List
Experience Course
CL Item
Intermittend -> Please fill in No. of episodes below (1)
Number of episodes
Item
If experience course intermittent, please fill in no. of episodes
integer
Item
Intensity (maximum)
text
Code List
Intensity (maximum)
Item
Action Taken with Respect to Investigational Drug
text
Code List
Action Taken with Respect to Investigational Drug
CL Item
Dose increased (3)
CL Item
Drug interrupted restarted (4)
Abatement
Item
Did the SAE abate?
boolean
Reintroduction of product
Item
If Investgational product was interrupted, stopped or dose reduced: Was investigational product reintroduced (or dose increased)?
boolean
Recurrence of SAE
Item
If yes, did SAE recur?
boolean
Item
Relationship to Investigational Drug
text
Code List
Relationship to Investigational Drug
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
Item
The SAE is probably associated with
text
Code List
The SAE is probably associated with
CL Item
Protocol design or procedures (but not to study drug) -> please specify below (1)
CL Item
Another condition (e.g condition under study, intercurrent illness) -> please specify below (2)
CL Item
Another drug (please specify below) (3)
Specification of Assessment
Item
Please specify Assessment
text
Item
Corrective Therapy
text
Code List
Corrective Therapy
CL Item
Yes (If "Yes", record details in the Concomitant Medication or Medical Procedures section) (1)
Withdrawal
Item
Was patient withdrawn due to this specific SAE?
text
Remarks
Item
Remarks
text
Randomizatin code broken
Item
If applicable, was randomization code broken at investigational side?
boolean
Randomization number
Item
Randomization Number (please do NOT enter the container number)
integer
Investigators signature
Item
Investigators signature (confirming that the above data are accurate and complete)
text
SB Medical Monitor´s Signature
Item
SB Medical Monitor´s Signature
text