Table 2.

Assessment of causality and severity of adverse events

Assessment of causality	Assessment of severity
Unrelated: where an event is not considered to be related to the study intervention	Mild: an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with every day activities.
Possibly: although a relationship to the study intervention cannot be completely ruled out, the nature of the event, the underlying disease, concomitant medication or temporal relationship make other explanations possible.	Moderate: an event that is sufficiently discomforting to interfere with normal everyday activities.
Probably: the temporal relationship and absence of a more likely explanation suggest the event could be related to the study intervention.	Severe: an event that prevents normal everyday activities
Definitely: The known effects of the study intervention or its physiological mechanisms suggest that study intervention is the most likely cause.