Hydroxychloroquine → Malaise — Audit-grade candidate (scan)

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Ledger entry · candidate

Hydroxychloroquine → Malaise — Audit-grade candidate (scan)

Drug: hydroxychloroquine · AE: Malaise

Discovered via single-drug scan of hydroxychloroquine. PRR = 2.22 (95% CI 2.10–2.35), n = 1235 cases. Pre-reg locked at submission time.

Disproportionality

PRR: 2.2218904563848922 (95% CI 2.10–2.35)
Yates χ²: 844.3339629149606
Cases (case-drug + AE): n = 1235
Verdict: PASSES_ALL_GATES — PRR=2.22 (95% CI 2.10–2.35), n=1235 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
No reactions surfaced in cohort.

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: 5c425e86fbc6c99b187057aa2c75e2fbdee92fcd