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) |