Safety evaluation
pneumonitis, death, congenital malformations/birth defects, interstitial lung disease
ADVERSE EVENTS, DRUG-INDUCED LIVER INJURY, INTERSTITIAL LUNG DISEASE, PNEUMONITIS
TEAEs were recorded and graded using the CTCAE 5.0 criteria. SAEs were defined as TEAEs resulting in death, hospitalization or prolongation of hospitalization, life-threatening consequences, permanent or severe disability/loss of function, or congenital malformations/birth defects. Non-serious adverse events of special interest included potential drug-induced liver injury and interstitial lung disease or pneumonitis.