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 |
a
Any grade in 10% or more of patients or grade 3 or higher in any patient.
b
Any grade in any patient.
c
The incidence of treatment-related infusion-related reaction based on the single Medical Dictionary for Regulatory Activities preferred term is not listed.
d
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).