| アブストラクト | INTRODUCTION: Pediatric adverse drug reactions are difficult to evaluate after approval because pediatric trial evidence is limited and spontaneous-report systems differ in product naming, event coding, seriousness fields, and duplicate submissions. METHODS: We developed a manufacturer-aware benchmark for pediatric pharmacovigilance signal concordance using the FDA Adverse Event Reporting System (FAERS)/AERS as the source system, Canada Vigilance as a cross-system reporting-signal comparator, and JADER for descriptive third-country context. Active ingredients and five clinically adjudicated serious endpoint families were harmonized before detectable manufacturer cross-filing was screened. RESULTS: The supervised benchmark contained 628 drug-endpoint-period rows: 147 manufacturer-screened Canada Vigilance reporting-signal positives and 481 Canada Vigilance co-report-absent comparators. An endpoint-conditioned FAERS co-reporting comparator achieved an area under the precision-recall curve (AUPRC) of 0.753. Elastic-net logistic regression reached 0.767, and a LightGBM comparator reached 0.774, but clustered paired-difference intervals versus the conditioned co-report comparator included zero. In 30 repeated drug-held-out partitions, chemical structure increased the mean AUPRC from 0.764 to 0.796, but the corresponding increment was -0.003 under unseen-scaffold partitions; target and pathway indicators produced no further material increase. Future-period support was concentrated in anaphylaxis: 40 drug pairs remained after manufacturer screening, including 37 with FAERS source exposure, and four of five FAERS scores ranked supported pairs above permutation expectations. DISCUSSION: Clinical label specificity, detectable duplicate screening, and fair source-signal comparators materially influenced model evaluation. The resulting resource provides a reproducible reference for pediatric signal triage and for testing whether new pharmacological features or models add information beyond established reporting statistics. |
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| ジャーナル名 | Frontiers in pharmacology |
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| Pubmed追加日 | 2026/9/22 |
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| 投稿者 | Shi, Jinwan; Xia, Jieting; Li, Huanqiong; Zhang, Shuyan; Shi, Bowen |
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| 組織名 | Foshan Sanshui District People's Hospital, Foshan, Guangdong, China.;School of Medical Information Engineering, Guangdong Pharmaceutical University,;Guangzhou, Guangdong, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42769231/ |
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