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.