Table 3. Treatment-Related Adverse Events, Infusion-Related Reactions, and Immune-Related Adverse Eventsa,b.
Adverse Event | Patients, No. (%) (N = 125) | |
---|---|---|
Any Grade | Grade 3 or 4 | |
Any treatment-relatedc | 86 (68.8) | 9 (7.2) |
Fatigue | 17 (13.6) | 0 |
Diarrhea | 15 (12.0) | 0 |
Nausea | 14 (11.2) | 1 (0.8) |
Rash | 9 (7.2) | 1 (0.8) |
Lipase-level increase | 3 (2.4) | 3 (2.4) |
Amylase-level increase | 2 (1.6) | 1 (0.8) |
Peripheral edema | 2 (1.6) | 1 (0.8) |
Localized edema | 2 (1.6) | 1 (0.8) |
Colitis | 1 (0.8) | 1 (0.8) |
Type 2 diabetes | 1 (0.8) | 1 (0.8) |
Myositis | 1 (0.8) | 1 (0.8) |
Any infusion-related reactiond | 25 (20.0) | 0 |
Any immune-related adverse event | 21 (16.8) | 3 (2.4) |
Colitis | 1 (0.8) | 1 (0.8) |
Type 2 diabetes | 1 (0.8) | 1 (0.8) |
Myositis | 1 (0.8) | 1 (0.8) |
Hypothyroidism | 8 (6.4) | 0 |
Maculopapular rash | 3 (2.4) | 0 |
Rash | 2 (1.6) | 0 |
Autoimmune hypothyroidism | 1 (0.8) | 0 |
Pruritus | 1 (0.8) | 0 |
Diarrhea | 1 (0.8) | 0 |
Erythema | 1 (0.8) | 0 |
Pneumonitis | 1 (0.8) | 0 |
Psoriasis | 1 (0.8) | 0 |
Thyroiditis | 1 (0.8) | 0 |
Any grade in 10% or more of patients or grade 3 or higher in any patient.
Any grade in any patient.
The incidence of treatment-related infusion-related reaction based on the single Medical Dictionary for Regulatory Activities preferred term is not listed.
Composite term, which includes 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).