Caliper validation of the submitted claim (drug=fezolinetant, AE=Hepatotoxicity). PRR = 3.86 (95% CI 1.93–7.71), n = 8 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.
PASSES_ALL_GATES — PRR=3.86 (95% CI 1.93–7.71), n=8 cases; flagged for clinical expert review, NOT for external escalation without manual verification| MedDRA PT | n |
|---|---|
| Hepatotoxicity | 8 |
| Hepatic enzyme increased | 2 |
| Blood pressure increased | 1 |
| Drug ineffective | 1 |
| Fatigue | 1 |
| Headache | 1 |
| Hot flush | 1 |
| Insomnia | 1 |
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