Center:
PI:
Subject #_____________________
ADVERSE EVENT LOG
No
Adverse Event
Serious
(Yes/No)
Start Date
dd/mmm/yyyy
End Date
dd/mmm/yyyy
□ Yes
Specify #
__
___________________
______
___/___/____
___/___/____
□ No
Initials (study nurse) :
Specify #
___________________
______
__/___/____
__/___/____
□ No
Initials (study nurse) :
Specify #
___________________
□ Yes
□ No
______
__/___/____
__/___/____
□ No
Initials (study nurse) :
□0
□1
□2
□3
□4
□5
□ Yes
□ No
□0
□1
□2
□3
□4
□5
□ Yes
□ No
□I
□ II
□ III
□ IV
□V
- Mild; asymptomatic or mild symptoms
- Clinical or diagnostic observation only
- Intervention not indicated
Grade II - Moderate –minimal, local, or non-invasive intervention indicated
Or limiting age-appropriate instrumental activities of daily living
Unrelated:
Unlikely:
Possible:
Probable:
Very Likely:
□
□
□
□
□
Investigator Signature
and Date
Signature:
_____________
Date:
__/___/____
Signature:
□I
□ II
□ III
□ IV
□V
Signature:
_____________
Date:
__/___/____
_____________
Date:
__/___/____
SAE
AEs that are not defined in the CTCAE should be evaluated according
to the following scale:
Grade I
Relationship to
study drug
(Done by the
investigator)
□I
□ II
□ III
□ IV
□V
Date : ___/____/______
Grade / CTCAE V4.03
Grade IV - Life-Threatening consequences
- Urgent intervention indicated
Grade V - Death related to adverse event
Grade III - Severe or medically significant, but not immediately life-threatening;
- Hospitalization or prolongation of hospitalization indicated;
- Disabling; limiting self-care activities of daily living
Page _____ of _____
Version 06 mars 2018
Grade
Date : ___/____/______
□ Yes
__
□0
□1
□2
□3
□4
□5
Concomitant
medication
was taken?
(Yes/No)
Date : ___/____/______
□ Yes
__
Action
taken
1- Results in death
2- Life threatening
3- Requires or prolongs hospitalization
4- Congenital anomaly or birth defect
5- Persistent or significant disability/incapacity
6- Other medically important serious event
Action Taken
0- Dose withdrawn
1- Dose interrupted
2- Dose reduced
3- Dose not changed
4- Not applicable
5- Unknown