an outcome reflecting the patient’s perspective on treatment-related adverse events in people with rheumatic and musculoskeletal diseases enrolled in clinical trials. It focuses on the severity, frequency, and interference of symptoms (as distinct from “signs”) across different body systems. This outcome captures how tolerable or disruptive side effects are from the patient’s point of view, providing a fuller picture of a therapy’s overall impact.
Example
In a phase III trial of a new biologic therapy for rheumatoid arthritis, safety outcomes included patient-reported data on nausea, headaches, and fatigue (severity and frequency), along with how much these symptoms interfered with daily activities. These data were compared to the placebo group to evaluate the drug’s overall tolerability.