Adverse Events (AE)
1.
Study Identifier
2.
Subject Identifier
3.
Visit
4.
Visit Number
(integer only)
5.
Visit Date
/
/
(mm/dd/yyyy)
6.
Sequence Number
(integer only)
7.
Reported Term for the Adverse Event
8.
Start Date of Event
/
/
(mm/dd/yyyy)
9.
End Date of Event
/
/
(mm/dd/yyyy)
10.
Body System or Organ Class
11.
Severity
Mild
Moderate
Severe
12.
Serious?
Yes
No
13.
Action Taken with Study Treatment
None
Reduce dose of study drug
Temperate stop study drug
Permanente stop study drug
Other
If last category is checked, please specify:
14.
Other Action Taken
15.
Causality
Not related
Possible
Probable
Very likely
16.
Relationship to Non-Study Treatment
17.
Outcome of Event
Resolved
Peresisting
Unknown
18.
Outcome of Event
mm
01
02
03
04
05
06
07
08
09
10
11
12
/
dd
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
/
(mm/dd/yyyy)
19.
Date of Collection
/
/
(mm/dd/yyyy)
20.
Involves Cancer?
Yes
No
21.
AE lead to Disability?
Permanent
Serious
Disable
Incapacitating
Other
If last category is checked, please specify:
22.
Results in Death?
Yes
No
23.
Requires or Prolongs Hospitalization?
Yes
No
24.
Is Life Threatening?
Yes
No
25.
Occurred with Overdose?
Yes
No
26.
Other Medically Important Serious Event
27.
Description of Other Medical Important Serious Events
28.
Concomitant or Additional Treatment Given
29
Comment
CDISC AE domain ODM metadata