Treatment-related adverse events (≥ 10% or any toxicities with grade 3 or higher).
| Cohort A (MSI-H) | Cohort B (MSS) | |||
|---|---|---|---|---|
| n = 10 | n = 40 | |||
| Adverse event, n (%) | All grades | Grade ≥3 | All grades | Grade ≥3 |
| All events | 10 (100) | 1 (10) | 40 (100) | 10 (25) |
| Diarrhea | 8 (80) | 0 (0) | 35 (87.5) | 2 (5.0) |
| Decreased appetite | 0 (0) | 0 (0) | 13 (32.5) | 3 (7.5) |
| Nausea | 4 (40) | 0 (0) | 11 (27.5) | 1 (2.5) |
| Vomiting | 1 (10) | 0 (0) | 7 (17.5) | 0 (0) |
| Fever | 4 (40) | 1 (10) | 6 (15.0) | 0 (0) |
| Malaise | 0 (0) | 0 (0) | 6 (15.0) | 0 (0) |
| Fatigue | 0 (0) | 0 (0) | 5 (12.5) | 0 (0) |
| Hypothyroidism | 2 (20) | 0 (0) | 5 (12.5) | 0 (0) |
| Rash | 2 (20) | 0 (0) | 3 (7.5) | 1 (2.5) |
| Abdominal pain | 2 (20) | 0 (0) | 2 (5.0) | 1 (2.5) |
| Anemia | 0 (0) | 0 (0) | 2 (5.0) | 1 (2.5) |
| Hypokalemia | 0 (0) | 0 (0) | 2 (5.0) | 1 (2.5) |
| Alanine aminotransferase increased | 0 (0) | 0 (0) | 2 (5.0) | 0 (0) |
| Infusion-related reaction | 1 (10) | 0 (0) | 1 (2.5) | 0 (0) |
| Hearing impaired | 0 (0) | 0 (0) | 1 (2.5) | 1 (2.5) |
| Colitis | 0 (0) | 0 (0) | 1 (2.5) | 1 (2.5) |
| Serum amylase increased | 0 (0) | 0 (0) | 1 (2.5) | 1 (2.5) |
| Alkaline phosphatase increased | 0 (0) | 0 (0) | 1 (2.5) | 1 (2.5) |
| Platelet count decreased | 1 (10) | 0 (0) | 0 (0) | 0 (0) |
| Cheilitis | 1 (10) | 0 (0) | 0 (0) | 0 (0) |