Caliper validation of the submitted claim (drug=empagliflozin, AE=acute kidney injury). PRR = 3.05 (95% CI 2.82–3.31), n = 583 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.
PASSES_ALL_GATES — PRR=3.05 (95% CI 2.82–3.31), n=583 cases; flagged for clinical expert review, NOT for external escalation without manual verification| MedDRA PT | n |
|---|---|
| Acute kidney injury | 429 |
| Diabetic ketoacidosis | 79 |
| Dehydration | 50 |
| Vomiting | 50 |
| Metabolic acidosis | 47 |
| Nausea | 40 |
| Hyperglycaemia | 38 |
| Ketoacidosis | 29 |
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