Table 5. Assigning type of SAE through causality.

Relationship	Description	SAE type
Unrelated	There is no evidence of any causal relationship	Unrelated SAE
Unlikely	There is little evidence to suggest that there is a causal relationship (for example, the event did not occur within a reasonable time after administration of the trial medication). There is another reasonable explanation for the event (for example, the participant’s clinical condition, other concomitant treatment).	Unrelated SAE
Possible	There is some evidence to suggest a causal relationship (for example, because the event occurs within a reasonable time after administration of the trial medication). However, the influence of other factors may have contributed to the event (for example, the participant’s clinical condition, other concomitant treatments).	SAR
Probable	There is evidence to suggest a causal relationship and the influence of other factors is unlikely.	SAR
Definitely	There is clear evidence to suggest a causal relationship and other possible contributing factors can be ruled out.	SAR

SAE, serious adverse event; SAR, serious adverse reaction.