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.