treatment-emergent adverse event
An adverse event that occurs during treatment and was not present at baseline, or worsens from baseline during therapy.
Full Definition
A treatment-emergent adverse event (TEAE) is any untoward medical occurrence that arises during the course of treatment with a pharmaceutical product, regardless of suspected causal relationship. TEAEs include new events that were not present before treatment initiation, as well as pre-existing conditions that worsen in severity, frequency, or character during treatment. In clinical trials, TEAEs are systematically collected and analyzed to assess drug safety profiles. The temporal relationship between drug exposure and adverse event onset is a key factor in causality assessment.
Usage
Usage note: Often abbreviated as TEAE; ensure consistent terminology when distinguishing from other adverse event categories.
In Context
- "The most common treatment-emergent adverse events were sedation, weight gain, and dry mouth." — Clinical trial safety summary
- "No treatment-emergent adverse events leading to discontinuation were reported in the placebo group." — Safety analysis report