Frequency Distribution Analysis
Frequency distribution analysis characterises adverse event occurrence patterns identifying rare and common safety signals. Reporting rate trends over time detect emerging adverse events. Disproportionality assessment compares observed versus expected frequencies. Signal detection methodologies identify statistically significant frequency increases. Statistical significance testing prevents chance fluctuation misinterpretation.
Population adjustments prevent reporting bias confounding frequency interpretation. International signal comparison identifies globally significant adverse events. Temporal clustering suggests causality. Dose-response frequency relationships support causal inference. Regulatory actions address identified frequency signals.
