Expectedness Evaluation

Determine expectedness using Reference Safety Information

Role: Drug Safety Associate

Context: You're assessing expectedness for several cases. You have access to the product's SmPC Section 4.8 (Adverse Reactions) for reference.

Task: Determine whether each adverse event is expected (listed) or unexpected (unlisted) based on the RSI.

Step 1 of 3

Case 1: Term Matching

case

SmPC Section 4.8 states: 'Common (≥1/100): headache, nausea, dizziness. Uncommon (≥1/1,000): rash, pruritus. Rare (≥1/10,000): hepatic enzyme elevation.' The reported event is: Patient experienced moderate nausea for 2 days after starting treatment.

Is 'moderate nausea for 2 days' expected or unexpected?