Patients, n (%) | 1 L-mn subgroup (n = 90) | 2 L subgroup (n = 60) | ||||||
---|---|---|---|---|---|---|---|---|
Any grade | Grade 3 | Grade 4 | Grade 5 | Any grade | Grade 3 | Grade 4 | Grade 5 | |
Any TRAEa | 57 (63.3) | 7 (7.8) | 0 | 1 (1.1) | 28 (46.7) | 3 (5.0) | 2 (3.3) | 0 |
Fatigue | 10 (11.1) | 2 (2.2) | 0 | 0 | 5 (8.3) | 0 | 0 | 0 |
Decreased appetite | 3 (3.3) | 0 | 0 | 0 | 2 (3.3) | 1 (1.7) | 0 | 0 |
Asthenia | 1 (1.1) | 0 | 0 | 0 | 3 (5.0) | 2 (3.3) | 0 | 0 |
Colitis | 2 (2.2) | 1 (1.1) | 0 | 0 | 0 | 0 | 0 | 0 |
Elevated amylase | 2 (2.2) | 0 | 0 | 0 | 1 (1.7) | 1 (1.7) | 0 | 0 |
Elevated lipase | 2 (2.2) | 1 (1.1) | 0 | 0 | 1 (1.7) | 0 | 1 (1.7) | 0 |
Elevated γ-glutamyltransferase | 2 (2.2) | 1 (1.1) | 0 | 0 | 0 | 0 | 0 | 0 |
Anemia | 1 (1.1) | 1 (1.1) | 0 | 0 | 1 (1.7) | 1 (1.7) | 0 | 0 |
Decreased platelet count | 1 (1.1) | 1 (1.1) | 0 | 0 | 1 (1.7) | 0 | 1 (1.7) | 0 |
Abdominal pain | 1 (1.1) | 1 (1.1) | 0 | 0 | 0 | 0 | 0 | 0 |
Adrenal insufficiency | 1 (1.1) | 0 | 0 | 0 | 1 (1.7) | 1 (1.7) | 0 | 0 |
Autoimmune hepatitisb | 1 (1.1) | 0 | 0 | 1 (1.1) | 0 | 0 | 0 | 0 |
Decreased hemoglobin | 1 (1.1) | 1 (1.1) | 0 | 0 | 0 | 0 | 0 | 0 |
Hepatic failureb | 1 (1.1) | 0 | 0 | 1 (1.1) | 0 | 0 | 0 | 0 |
Hyperglycemia | 1 (1.1) | 1 (1.1) | 0 | 0 | 0 | 0 | 0 | 0 |
Hypokalemia | 1 (1.1) | 1 (1.1) | 0 | 0 | 0 | 0 | 0 | 0 |
Peripheral motor neuropathy | 1 (1.1) | 1 (1.1) | 0 | 0 | 0 | 0 | 0 | 0 |
Infusion-related reactionc | 20 (22.2) | 1 (1.0) | 0 | 0 | 11 (18.3) | 0 | 0 | 0 |
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