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

Table 2 Results of NAE review in 2 completed clinical trials

Event category	Number of events (% of NAEs)
Event category	Trial A (N = 1774 NAEs; 26.2% of site-reported COEs)	Trial B (N = 1208 NAEs; 44.1% of site-reported COEs)
Same causal pathway^a	1168 (65.8%)	490 (40.6%)
Not same causal pathway^a	606 (34.2%)	718 (59.4%)
AE/SAE already reported	118 (6.7%)	517 (42.8%)
Alternative COE	369 (20.8%)	71 (5.9%)
Potential new AE	119 (6.7%)	130 (10.8%)
New AE reported	2 (0.1%)	20 (1.7%)
SUSAR	0 (0.0%)	2 (0.2%)

^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

ISSN: 1745-6215