Ledger entry · null-result
Ozanimod → Bradycardia — Null result
Drug: ozanimod · AE: Bradycardia
Caliper validation of the submitted claim (drug=ozanimod, AE=Bradycardia). BELOW_PRR_THRESHOLD — disproportionality not significant (PRR=0.83, lower CI=0.54)
Disproportionality
- PRR: 0.8290981717050147
(95% CI 0.54–1.27)
- Yates χ2: 0.5803275837511528
- Cases (case-drug + AE): n = 21
- Verdict:
BELOW_PRR_THRESHOLD — disproportionality not significant (PRR=0.83, lower CI=0.54)
Top reactions in cohort
| MedDRA PT | n |
|---|
| Bradycardia | 20 |
| Dizziness | 4 |
| Headache | 2 |
| Vision blurred | 2 |
| Abdominal pain | 1 |
| Asthenia | 1 |
| Blood pressure decreased | 1 |
| COVID-19 | 1 |
Source: openFDA FAERS, Caliper Engine v0. Pre-registration sha1 locked at submission time; ledger entry signed with platform Ed25519 key.