Caliper validation of the submitted claim (drug=fezolinetant, AE=Hepatic enzyme increased). PRR = 27.01 (95% CI 23.41–31.15), n = 172 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.
PASSES_ALL_GATES — PRR=27.01 (95% CI 23.41–31.15), n=172 cases; flagged for clinical expert review, NOT for external escalation without manual verification| MedDRA PT | n |
|---|---|
| Hepatic enzyme increased | 171 |
| Fatigue | 8 |
| Abdominal pain | 5 |
| Off label use | 5 |
| Drug ineffective | 4 |
| Nausea | 4 |
| Abdominal pain upper | 3 |
| Alanine aminotransferase increased | 3 |
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