Ledger entry · null-result
Tezepelumab → Headache — Null result
Drug: tezepelumab · AE: Headache
Caliper validation of the submitted claim (drug=tezepelumab, AE=Headache). BELOW_PRR_THRESHOLD — disproportionality not significant (PRR=1.27, lower CI=1.12)
Disproportionality
- PRR: 1.2713367511506966
(95% CI 1.12–1.45)
- Yates χ2: 13.102968027653922
- Cases (case-drug + AE): n = 224
- Verdict:
BELOW_PRR_THRESHOLD — disproportionality not significant (PRR=1.27, lower CI=1.12)
Top reactions in cohort
| MedDRA PT | n |
|---|
| Headache | 176 |
| Arthralgia | 26 |
| Nausea | 25 |
| Dyspnoea | 23 |
| Fatigue | 23 |
| Asthma | 20 |
| Dizziness | 20 |
| Back pain | 16 |
Source: openFDA FAERS, Caliper Engine v0. Pre-registration sha1 locked at submission time; ledger entry signed with platform Ed25519 key.