Signal Detection Basics

Recognize patterns that may indicate emerging safety signals

Role: Signal Detection Lead

Context: Your quarterly signal detection review is due. You're analyzing data from your safety database for Cardizol (antihypertensive, marketed 3 years, ~500,000 patient-years exposure).

Task: Evaluate each data pattern and determine if signal investigation is warranted.

Step 1 of 3

Pattern 1: The Frequency Shift

case

Disproportionality analysis for 'tendon rupture' with Cardizol: PRR (Proportional Reporting Ratio): 3.8 (threshold: >2.0) Reporting Rate: Q1: 2 cases, Q2: 3 cases, Q3: 8 cases, Q4: 12 cases Total cases: 25 Tendon rupture is NOT in Cardizol labeling. Background incidence: ~3 per 100,000 per year.

Does this pattern warrant signal investigation?