CRF ID:
CDE ID:
PV Group Id:
Permissible Values:
Permissible Value Codes:
Additional Notes:
Unexpected Adverse Event
Disease Specific Instructions:
Choose Yes or No. This question should be answered YES if the AE was not previously identified as an adverse event associated with use of the investigational drug or medical device, based on those described in the Investigator's Brochure. An event may also be identified as unexpected if the adverse event increased in frequency or severity than what is described by the Investigator's Brochure.
Disease Specific Reference:
No references available
Population:
Adult;Pediatric
Classification:
Supplemental
CDE Order:
13
Notes:
Keywords:
Sub Set Id:
1576