Table 3 Causality of adverse events
Causality | Definition |
|---|---|
Almost certainly | Starts within a time related to the operation of the device, and No obvious alternative medical explanation |
Probably | Starts within a time related to the operation of the device, and Cannot be reasonably explained by known characteristics of the patient’s clinical state |
Possibly | Starts within a time related to the operation of the device, and A causal relationship between the operation of the device and the adverse event is at least a reasonable possibility |
Unrelated | The AE is definitely not associated with the study device |