treatment-emergent
Adverse events or symptoms that occur or worsen after treatment initiation, used to establish causal relationship with study drug.
Full Definition
Treatment-emergent refers to adverse events, side effects, or symptoms that either begin after treatment initiation or worsen from baseline during the treatment period. This temporal relationship is crucial for regulatory submissions as it helps establish potential causality between the investigational drug and observed adverse events. Treatment-emergent adverse events (TEAEs) are typically defined as events occurring on or after the first dose of study medication through a specified follow-up period. The distinction between treatment-emergent and pre-existing conditions is essential for safety analysis and regulatory review.
Usage
Usage note: Always hyphenate when used as a compound modifier before a noun.
In Context
- "Treatment-emergent sexual dysfunction was reported in 23% of patients receiving the active drug." — Safety results
- "Only treatment-emergent adverse events were included in the causality assessment." — Safety analysis methodology