Which best describes how safety findings should be presented in the final report?

• A. Narrative only
• B. Only the most common adverse events
• C. Without any numbers
• D. Present safety findings in aggregated summaries by system organ class and preferred terms, incidence rates, and time-to-event analyses as appropriate

Answer: (D)

In final trial reporting, safety findings are most informative when presented in aggregated summaries by system organ class and preferred term, with incidence rates and, where appropriate, time-to-event analyses. This standardizes how events are described using MedDRA terms (SOC and PT), making it easier to spot patterns across organ systems and treatment groups. Including incidence rates provides a clear sense of how often adverse events occur, while time-to-event analyses reveal when they tend to happen, helping to identify early toxicities or timing trends related to the investigational product. This approach supports transparent risk assessment and regulatory review, and can accommodate serious events within the same structured framework when relevant.

Narrative-only reporting can obscure the scope and frequency of safety signals, and focusing only on the most common adverse events may miss less frequent but clinically important signals. Presenting safety data without numbers leaves readers unable to gauge the true magnitude of risk.