Skip to main content

Advertisement

Table 3 Causality of adverse events

From: Extracorporeal shockwave therapy for the treatment of lower limb intermittent claudication: study protocol for a randomised controlled trial (the SHOCKWAVE 1 trial)

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