TABLE 2.
Treatment-Related Adverse Events (n = 19)
| Any Grade, No. (%) | Grade 3–5, No. (%) | |
|---|---|---|
| Any | 16 (84.2) | 7 (36.8) |
| Serious | 6 (31.6) | 4 (21.1) |
| Led to discontinuation | 0 (0.0) | 0 (0.0) |
| Lead to death | 0 (0.0) | 0 (0.0) |
| >10% of patients | ||
| Fatigue | 7 (36.8) | 0 (0) |
| Rash, maculopapular | 5 (26.3) | 3 (15.8) |
| Nausea | 4 (21.1) | 1 (5.3) |
| Aspartate aminotransferase increased | 4 (21.1) | 0 (0) |
| Lipase increased | 3 (15.8) | 2 (10.5) |
| Alanine aminotransferase increased | 3 (15.8) | 0 (0) |
| Hypothyroidism | 3 (15.8) | 0 (0) |
| Pruritus | 3 (15.8) | 0 (0) |
| Vomiting | 3 (15.8) | 0 (0) |
| Anemia | 2 (10.5) | 1 (5.3) |
| Alkaline phosphatase increased | 2 (10.5) | 0 (0) |
| Chills | 2 (10.5) | 0 (0) |
| Pain | 2 (10.5) | 0 (0) |
| Immune-mediated | 13 (68.4) | 4 (21.1) |
| Rash, maculopapular | 5 (26.3) | 3 (15.8) |
| Aspartate aminotransferase increased | 4 (21.1) | 0 (0) |
| Lipase increased | 3 (15.8) | 2 (10.5) |
| Alanine aminotransferase increased | 3 (15.8) | 0 (0) |
| Hypothyroidism | 3 (15.8) | 0 (0) |
| Pruritus | 3 (15.8) | 0 (0) |
| Diarrhea | 1 (5.3) | 0 (0) |
| Hyperthyroidism | 1 (5.3) | 0 (0) |
| Infusion-related reaction | 1 (5.3) | 0 (0) |
| Serum amylase increased | 1 (5.3) | 0 (0) |