Question

A participant reported migraine headache and missed work for a day. Is this an AE?
A. Check baseline medical history
B. Assess the severity level
C. Assess if there is change from baseline.
D. All of the above.

Answer 1

"(b) Assess the severity level"

Explanation:

AE - Adverse Event

The person who have an unexpected medical problem, is called as AE.

AE happens during treatment with a drug or other therapy.Normally, adverse events may be mild, moderate or severe.that may be caused by other than the therapy being given, this is also called as AE  .

Here, A participant reported migraine headache and missed work for a day. It should be assess the severity level first.

option (b) Assess the severity level is an AE