GPT and urinary tract infection: In cohort 7, serious TRAEs of grade 3 or higher occurred in 9 (22.5%) patients, including increased alanine aminotransferase, hemoptysis, sudden death, acute kidney injury, renal impairment, herpes zoster, urinary tract infection, pneumonia fungal, drug-induced liver injury, cerebral infarction, cerebral hemorrhage, arthralgia, hyperthyroidism, and hypertension (n = 1 for each; 2.4%) (Table S2.