Table 6.

Assigning Type of AE/AR through causality

Relationship	Description	AE type
Unrelated	There is no evidence of any causal relationship.	Unrelated AE
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 the administration of the trial medication). There is another reasonable explanation for the event (for example, the patient’s clinical condition, and other concomitant treatment).	Unrelated AE
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 patient’s clinical condition, and other concomitant treatments).	AR
Probable	There is evidence to suggest a causal relationship and the influence of other factors is unlikely.	AR
Definitely	There is clear evidence to suggest a causal relationship and other possible contributing factors can be ruled out.	AR