<p>FAERS de-duplicated event-level analytic dataset.</p>

Representative shared PT signals included dizziness (12.94/14.33), taste disorder (38.03/13.28), renal impairment (6.89/8.18), blood creatinine increased (8.31/24.99), cardiac failure (7.57/8.90), cognitive disorder (18.04/78.29), ataxia (51.73/351.45), syncope (8.87/89.45), myocarditis (3.47/5.91), electrocardiogram QT prolonged (4.01/5.35), and hyperuricaemia (7.36/59.63). Subgroup analyses suggested exploratory age- and sex-related reporting heterogeneity, including relatively more renal and mobility-related reports in older patients and female predominance for ataxia in FAERS.

In the FAERS-based time-to-onset analysis, 203 of 520 reports (39.0%) had valid onset data. The median time to onset was 13 days, 70.94% of evaluable reports had onset dates within 30 days, and Weibull analysis suggested an early-failure pattern.</p> <p>Conclusions</p><p>Entrectinib-associated reports in NSCLC showed reproducible neurologic, cardiac, renal, and laboratory-related disproportional reporting signals across FAERS and JADER.

These findings may help prioritize early safety monitoring but should be interpreted as hypothesis-generating signals rather than evidence of incidence or causality.</p></div>