Caliper validation of the submitted claim (drug=isotretinoin, AE=depression). PRR = 6.04 (95% CI 5.79–6.31), n = 1943 cases. Pre-reg locked at submission; awaiting Adam's review before public ship.
PASSES_ALL_GATES — PRR=6.04 (95% CI 5.79–6.31), n=1943 cases; flagged for clinical expert review, NOT for external escalation without manual verification| MedDRA PT | n |
|---|---|
| Depression | 1901 |
| Suicidal ideation | 317 |
| Anxiety | 241 |
| Mood altered | 144 |
| Inflammatory bowel disease | 98 |
| Mood swings | 83 |
| Colitis ulcerative | 82 |
| Dry skin | 81 |
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