Valproate → Neural tube defect — Audit-grade candidate

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Ledger entry · candidate

Valproate → Neural tube defect — Audit-grade candidate

Drug: valproate · AE: Neural tube defect

Caliper validation of the submitted claim (drug=valproate, AE=Neural tube defect). PRR = 12.74 (95% CI 6.60–24.59), n = 9 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.

Disproportionality

PRR: 12.743274030249802 (95% CI 6.60–24.59)
Yates χ²: 84.90979527853689
Cases (case-drug + AE): n = 9
Verdict: PASSES_ALL_GATES — PRR=12.74 (95% CI 6.60–24.59), n=9 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
Foetal exposure during pregnancy	8
Neural tube defect	8
Arnold-Chiari malformation	2
Autism spectrum disorder	2
Cognitive disorder	2
Disturbance in attention	2
Hydrocephalus	2
Learning disorder	2

Source: openFDA FAERS, Caliper Engine v0. Pre-registration sha1 locked at submission time; ledger entry signed with platform Ed25519 key.

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Reference: 1e8ca65cd73b0d9ca7d3b5d39525cd9348173123