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oai:figshare.com:article/33811144 2026-09-15T17:36:33Z category_4 category_7 category_12 category_13 category_21 category_106 category_61 category_62 category_64 category_132 portal_5 item_type_3 month_year_09_2026

FAERS de-duplicated event-level analytic dataset. JiaLe Yang (24948415) JiaWen Liu (24948418) GuanBo Zhao (24948421) HeChen Li (24948424) Ge Sun (332789) Biochemistry Medicine Cell Biology Genetics Biotechnology Science Policy Developmental Biology Marine Biology Cancer Infectious Diseases world reporting patterns whereas 58 pts reporting odds ratio molecular fusion status four disproportionality methods database pharmacovigilance study 2020q1 &# 8211 related reporting heterogeneity weibull analysis suggested generating signals rather 45 ), syncope 45 ), myocarditis valid onset data xlink "> entrectinib xlink "> reports 29 ), ataxia jader related reports onset analysis 43 ), 35 ), 23 signals evaluable reports associated reports 520 reports urinary disorders safety profile positive non older patients nsclc ), median time including relatively identify cross female predominance explore age evaluate time characterize real based time 92 ). 63 ). 573 preferred 520 patients 254 patients 0 %) <div> BackgroundEntrectinib is effective for ROS1-positive non-small cell lung cancer (NSCLC), but its postmarketing safety profile remains incompletely characterized outside clinical trials. We conducted a dual-database pharmacovigilance study to characterize real-world reporting patterns, identify cross-database replicated adverse event signals, explore age- and sex-related reporting heterogeneity, and evaluate time-to-onset patterns. MethodsReports were retrieved from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS; 2020Q1–2025Q4; 520 patients; 1,573 preferred-term [PT] events) and the Japanese Adverse Drug Event Report database (JADER; 2020Q1–2025Q3; 254 patients; 393 PT events). Molecular fusion status was not available for verification. Four disproportionality methods were applied, with reporting odds ratio (ROR) as the primary signal criterion. ResultsAt the system organ class level, shared positive signals involved nervous system disorders (FAERS/JADER ROR: 4.48/4.76), cardiac disorders (3.20/5.43), and renal and urinary disorders (2.04/3.92). At the PT level, 23 signals were detected in both databases, whereas 58 PTs were unique to FAERS and 8 to JADER. 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. ConclusionsEntrectinib-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.</div> 2026-09-15T17:36:21Z Dataset Dataset 10.1371/journal.pone.0358331.s009 https://figshare.com/articles/dataset/_p_FAERS_de-duplicated_event-level_analytic_dataset_p_/33811144 CC BY 4.0