treatment-emergent adverse event
An adverse event that occurs after the start of study treatment and was not present at baseline.
Full Definition
A treatment-emergent adverse event (TEAE) is any adverse event that begins on or after the first dose of study medication, or any pre-existing condition that worsens in severity after treatment initiation. This distinction is crucial in clinical trials to determine whether adverse events are potentially related to the investigational treatment rather than pre-existing conditions or the underlying disease being studied. TEAEs are typically categorized by severity, relationship to study drug, and whether they lead to study discontinuation. In psychiatric research, careful documentation of TEAEs is particularly important due to the potential for neuropsychiatric side effects and the need to distinguish treatment effects from disease progression.
Usage
Usage note: Use 'treatment-emergent adverse event' in full on first mention, then 'TEAE' for subsequent references.
In Context
- "Treatment-emergent adverse events were reported by 78% of patients in the active treatment group." — safety results section
- "The most common treatment-emergent adverse event was mild nausea, occurring in 15% of subjects." — safety summary