Safety evaluation of afatinib in patients with a history of interstitial lung disease using data from an administrative claims database in Japan

In patients with a history of ILD, the incidence of severe ILD following afatinib treatment was clarified. CART-derived findings should be interpreted as exploratory signals suggesting clustering of severe ILD events within particular patient profiles. However, as severe ILD was identified using claims-based operational definitions, outcome misclassification cannot be excluded despite sensitivity analyses. Further studies are warranted to validate these findings in independent real-world datasets with richer clinical detail and to support more precise stratification of severe ILD occurrence.