Aspirin → headache — Null result

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Ledger entry · null-result

Aspirin → headache — Null result

Drug: aspirin · AE: headache

Caliper validation of the submitted claim (drug=aspirin, AE=headache). BELOW_PRR_THRESHOLD — disproportionality not significant (PRR=0.86, lower CI=0.80)

Disproportionality

PRR: 0.8633132315453584 (95% CI 0.80–0.93)
Yates χ²: 15.363064049534309
Cases (case-drug + AE): n = 695
Verdict: BELOW_PRR_THRESHOLD — disproportionality not significant (PRR=0.86, lower CI=0.80)

Top reactions in cohort

MedDRA PT	n
Headache	50
Nausea	15
Dizziness	13
Dyspnoea	11
Drug ineffective	10
Pain	9
Feeling abnormal	8
Fall	7

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: 33fb95387128d6d63e1d2068a5c36f514c936307