A novel standard to evaluate the impact of therapeutic agents on patient safety - The BURDEN OF THERAPY™.

Purpose: Currently, treatment-emergent adverse events (TEAEs) during a clinical study are summarized over the entire study period.

Objective: Develop and validate a novel methodology, BURDEN OF THERAPY (BOTh), to quantify presence and severity of TEAEs on each day of study.

Methods: BOTh utilizes patient-level safety data to derive a quantitative estimate for the burden of TEAEs that all or individual patients experience on each day of a clinical study.