An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

A Dose Limiting Toxicity (DLT) is a treatment-related adverse event that is severe enough to prevent an increase in dose or continuation of therapy. DLTs include specific hepatic, hematologic, dermatologic, and other toxicities, such as Grade 4 liver enzyme elevations, Grade 4 cytopenias, persistent Grade 3 rashes, or serious organ toxicities unresponsive to treatment. Certain Grade 3 events (e.g., transient nausea, electrolyte imbalances) are excluded if they resolve quickly or with standard care.