Table 1 SAE causality rating
Relationship | Description | Event type |
|---|---|---|
Unrelated | There is no evidence of any causal relationship | Unrelated SAE |
Unlikely to be related | There is little evidence to suggest that there is a causal relationship (e.g. the event did not occur within a reasonable time after administration of the trial treatment). There is another reasonable explanation for the event (e.g. the participant’s clinical condition or other concomitant treatment) | Unrelated SAE |
Possibly related | There is some evidence to suggest a causal relationship (e.g. because the event occurs within a reasonable time after administration of the trial treatment). However, the influence of other factors may have contributed to the event (e.g. the participant’s clinical condition or other concomitant treatment) | SAR |
Probably related | There is evidence to suggest a causal relationship and the influence of other factors is unlikely | SAR |
Definitely related | There is clear evidence to suggest a causal relationship and other possible contributing factors can be ruled out | SAR |