Table 8 Assigning type of SAE through causality
Relationship | Description | SAE type |
|---|---|---|
Definitely | There is clear evidence to suggest a causal relationship and other possible contributing factors can be ruled out | SAR |
Probable | There is evidence to suggest a causal relationship and the influence of other factors is unlikely | SAR |
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 child’s clinical condition, other concomitant treatments) | SAR |
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 child’s clinical condition, other concomitant treatment) | Unrelated SAE |
Unrelated | There is no evidence of any causal relationship | Unrelated SAE |