Any-grade TRAEs occurring in ≥10% of patients or grade ≥3 in any patient and infusion-related reactions in the first-line switch-maintenance or second-line subgroup

Patients, n (%)1 L-mn subgroup (n = 90)2 L subgroup (n = 60)
Any gradeGrade 3Grade 4Grade 5Any gradeGrade 3Grade 4Grade 5
Any TRAEa57 (63.3)7 (7.8)01 (1.1)28 (46.7)3 (5.0)2 (3.3)0
 Fatigue10 (11.1)2 (2.2)005 (8.3)000
 Decreased appetite3 (3.3)0002 (3.3)1 (1.7)00
 Asthenia1 (1.1)0003 (5.0)2 (3.3)00
 Colitis2 (2.2)1 (1.1)000000
 Elevated amylase2 (2.2)0001 (1.7)1 (1.7)00
 Elevated lipase2 (2.2)1 (1.1)001 (1.7)01 (1.7)0
 Elevated γ-glutamyltransferase2 (2.2)1 (1.1)000000
 Anemia1 (1.1)1 (1.1)001 (1.7)1 (1.7)00
 Decreased platelet count1 (1.1)1 (1.1)001 (1.7)01 (1.7)0
 Abdominal pain1 (1.1)1 (1.1)000000
 Adrenal insufficiency1 (1.1)0001 (1.7)1 (1.7)00
 Autoimmune hepatitisb1 (1.1)001 (1.1)0000
 Decreased hemoglobin1 (1.1)1 (1.1)000000
 Hepatic failureb1 (1.1)001 (1.1)0000
 Hyperglycemia1 (1.1)1 (1.1)000000
 Hypokalemia1 (1.1)1 (1.1)000000
 Peripheral motor neuropathy1 (1.1)1 (1.1)000000
Infusion-related reactionc20 (22.2)1 (1.0)0011 (18.3)000

aThe incidence of treatment-related infusion-related reaction based on the single MedDRA preferred term is not listed

bOccurred in the same patient

cIncludes adverse events categorized as infusion-related reaction, drug hypersensitivity, or hypersensitivity reaction that occurred on the day of infusion or day after infusion, in addition to signs and symptoms of infusion-related reaction that occurred on the same day of infusion and resolved within 2 days (including adverse events classified by investigators as related or unrelated to treatment)

1 L-mn first-line switch-maintenance, 2 L second line, TRAE treatment-related adverse event