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Table 2 Results of NAE review in 2 completed clinical trials

From: Methods for safety and endpoint ascertainment: identification of adverse events through scrutiny of negatively adjudicated events

Event categoryNumber of events (% of NAEs)
Trial A (N = 1774 NAEs; 26.2% of site-reported COEs)Trial B (N = 1208 NAEs; 44.1% of site-reported COEs)
Same causal pathwaya1168 (65.8%)490 (40.6%)
Not same causal pathwaya606 (34.2%)718 (59.4%)
AE/SAE already reported118 (6.7%)517 (42.8%)
Alternative COE369 (20.8%)71 (5.9%)
Potential new AE119 (6.7%)130 (10.8%)
New AE reported2 (0.1%)20 (1.7%)
SUSAR0 (0.0%)2 (0.2%)
  1. a Causal pathway designation determined by CEC adjudicator based on whether the NAE was caused by the same or similar pathophysiologic process as the site-reported potential clinical outcome event (i.e. myocardial infarction and unstable angina), or whether it was caused by an alternative pathophysiologic process. AE adverse event, COE clinical outcome event, NAE negatively adjudicated event, SAE serious adverse event, SUSAR suspected unexpected serious adverse reaction