dose-limiting toxicity
Severe adverse effect that prevents further dose escalation in clinical trials.
Full Definition
Dose-limiting toxicity (DLT) refers to a severe adverse effect that occurs at a specific dose level and prevents further dose escalation in a clinical trial. DLTs are predefined in clinical trial protocols and typically include life-threatening or severe toxicities that significantly impact patient safety or quality of life. The identification of DLTs helps determine the maximum tolerated dose (MTD) of investigational agents and establishes safe dosing recommendations for subsequent clinical development phases.
Usage
Usage note: Hyphenate when used as adjective. Abbreviate as DLT after first use.
In Context
- "Two patients experienced dose-limiting toxicity at the 400mg dose level." — Phase I trial report
- "The protocol defined dose-limiting toxicity as any grade 4 non-hematologic toxicity." — Clinical trial protocol