Rosiglitazone → Myocardial infarction — Audit-grade candidate

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Ledger entry · candidate

Rosiglitazone → Myocardial infarction — Audit-grade candidate

Drug: rosiglitazone · AE: Myocardial infarction · vs pioglitazone

Caliper validation of the submitted claim (drug=rosiglitazone, AE=Myocardial infarction, comparator=pioglitazone). PRR = 20.93 (95% CI 19.72–22.21), n = 863 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.

Disproportionality

PRR: 20.927150295465278 (95% CI 19.72–22.21)
Yates χ²: 16450.385802908935
Cases (case-drug + AE): n = 863
Verdict: PASSES_ALL_GATES — PRR=20.93 (95% CI 19.72–22.21), n=863 cases; flagged for clinical expert review, NOT for external escalation without manual verification

Top reactions in cohort

MedDRA PT	n
MYOCARDIAL INFARCTION	587
Myocardial infarction	246
CARDIAC FAILURE CONGESTIVE	154
DEATH	100
Cardiac failure congestive	98
Coronary artery disease	98
CEREBROVASCULAR ACCIDENT	66
CORONARY ARTERY DISEASE	49

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: c65c10e1e85c090edbe282f414ed841519fadf9c