Table 3 Definitions of causality
Relationship | Description |
|---|---|
Unrelated | There is no evidence of any causal relationship |
Unlikely | There is little evidence to suggest there is a causal relationship (e.g. the event did not occur within a reasonable time after administration of the study procedure). There is another reasonable explanation for the event (e.g. the participant’s clinical condition or other concomitant treatment) |
Possible | There is some evidence to suggest a causal relationship (e.g. because the event occurs within a reasonable time after administration of the study procedure). However, the influence of other factors may have contributed to the event (e.g. the participant’s clinical condition or other concomitant treatments) |
Probable | There is evidence to suggest a causal relationship and the influence of other factors is unlikely |
Definitely | There is clear evidence to suggest a causal relationship and other possible contributing factors can be ruled out |
Not assessable | There is insufficient or incomplete evidence to make a clinical judgement of the causal relationship |