Tezepelumab → Headache — Null result

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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.

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Reference: 060e0cb6a21f5650d11e4438ccd499c7cf24804a