1. SAE Start Date
Item
1. SAE Start Date
date
2. SAE Stop Date
Item
2. SAE Stop Date
date
3. Location of serious adverse event
Item
3. Location of serious adverse event
text
4. Was this an unexpected adverse event?
Item
4. Was this an unexpected adverse event?
boolean
Item
5. Brief description of participant(s) with no personal identifiers: Sex
text
Code List
5. Brief description of participant(s) with no personal identifiers: Sex
5. Brief description of participant(s) with no personal identifiers
Item
5. Brief description of participant(s) with no personal identifiers: Age
integer
6. Brief description of the nature of the serious adverse event
Item
6. Brief description of the nature of the serious adverse event
text
Item
7. Category of the serious adverse event
text
Code List
7. Category of the serious adverse event
CL Item
death - date:____ (1)
CL Item
life-threatening (2)
CL Item
hospitalization-initial or prolonged (3)
CL Item
disability/incapacity (4)
CL Item
congenital anomaly / birth defect (5)
CL Item
required intervention to prevent permanent impairment (6)
If Other, please specify
Item
If Other, please specify
text
8. Intervention type
Item
8. Intervention type: Medication or Nutritional Supplement
boolean
Specification
Item
Please specify
text
Intervention type
Item
Intervention type: Device
boolean
Specification
Item
Please specify
text
Intervention type
Item
Intervention type: Surgery
boolean
Specification
Item
Please specify
text
Intervention type
Item
Intervention type: Behavioral/ Life Style
boolean
Specification
Item
Please specify
text
Item
9. Relationship of intervention
text
Code List
9. Relationship of intervention
CL Item
unrelated (clearly not related to the intervention) (1)
CL Item
possible (may be related to intervention) (2)
CL Item
definite (clearly related to intervention) (3)
10. Was study intervention discontinued due to event?
Item
10. Was study intervention discontinued due to event?
boolean
11. What medications or other steps were taken to treat serious adverse event?
Item
11. What medications or other steps were taken to treat serious adverse event?
text
12. List any relevant tests, laboratory data, history, including preexisting medical conditions
Item
12. List any relevant tests, laboratory data, history, including preexisting medical conditions
text
Item
13. Type of report
text
Code List
13. Type of report
Signature of Principal Investigator
Item
Signature of Principal Investigator
text