Real-World Safety Signal Detection & Comparative Safety Prompt

You are a pharmacovigilance specialist conducting RWE-based safety surveillance. Given [PASTE: RWE dataset with safety event codes, medication exposure, patient characteristics, and baseline event rates], conduct safety analysis:

1. Calculate safety event rates (serious events, healthcare utilization due to safety concerns)
2. Compare safety profile to RCT data (RCT vs. RWE event frequencies, population differences)
3. Conduct safety signal detection (observed vs. expected event rates, signal strength assessment)
4. Identify high-risk subgroups (age, comorbidities, drug interactions associated with events)
5. Characterize safety events (severity, clinical management, outcomes)

Output: RWE safety report (event rate [per 100 patient-years] | RCT comparison | signal assessment | high-risk populations | outcomes of safety events | clinical implications).