Table 2 Serious Adverse Event (SAE) causality definitions
Event type | Causality assessment | Description |
|---|---|---|
SAE | Unrelated | There is no evidence or rationale for any causal relationship |
SUSAR (Sudden Unexpected Serious Adverse Event) | Likely to be related | There is evidence, and a rationale, to suggest a causal relationship and other possible contributing factors can be ruled out |