Real-world safety profile of mitotane in adrenocortical carcinoma: a retrospective cross‑sectional study integrating pharmacovigilance and interpretable machine learning

Cancer research · Adrenocortical carcinoma

This large-scale study provides a real‑world safety assessment of mitotane.

Mitotane remains the cornerstone of adrenocortical carcinoma. However, its real‑world safety profile is poorly defined. This study systemically evaluated mitotane‑associated adverse events (AEs) and characterized multivariable patterns of serious outcomes using a combined pharmacovigilance and machine learning approach.

Mitotane is the only FDA‑approved pharmacologic agent for adrenocortical carcinoma, but its safety profile in routine clinical practice is uncertain.

Evidence level: Korai humán adat. Kis vagy feltáró emberi adat.

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