Adverse Event Causality Sample Clauses

Adverse Event Causality. The Investigator will make a judgment regarding the relationship of the AE to study treatment (for each study drug), as defined below. • Not related: These events will lack a strong temporal relationship of the event to the study treatment, making a causal relationship not reasonably possible. Exposure to other drugs, therapeutic interventions, or underlying conditions may provide a sufficient explanation for the event. • Related: There is a temporal relationship of the event to the study treatment making a definitive or reasonably possible relationship, and the event is more likely explained by exposure to the study treatment than by any other drugs, therapeutic interventions, or underlying conditions.