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Table 2 Serious Adverse Event (SAE) causality definitions

From: Protocol for a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care homes: the CHIPPS study

Event typeCausality assessmentDescription
SAEUnrelatedThere is no evidence or rationale for any causal relationship
SUSAR (Sudden Unexpected Serious Adverse Event)Likely to be relatedThere is evidence, and a rationale, to suggest a causal relationship and other possible contributing factors can be ruled out