Valproate → neural tube defects — Null result

Drug: valproate · AE: neural tube defects

Caliper validation of the submitted claim (drug=valproate, AE=neural tube defects). BELOW_DEDUP_THRESHOLD — only 0 unique cases after dedup; insufficient signal density

Disproportionality

• PRR: 331.3086591715584 (95% CI 13.50–8133.02)
• Yates χ²: 247.99410750486194
• Cases (case-drug + AE): n = 0
• Verdict: BELOW_DEDUP_THRESHOLD — only 0 unique cases after dedup; insufficient signal density

Top reactions in cohort

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