Table 4 Treatment-related adverse events
Toxicity | Immune checkpoint inhibitor (n = 127) | Irinotecan-based chemotherapy (n = 233) |  | ||
|---|---|---|---|---|---|
No. of patients (%) | No. of patients (%) | Â | |||
| Â | Any grade | G3-4 | Any grade | G3-4 | P-value for any grade/G3-4 AE |
Hematologic | Â | Â | Â | Â | Â |
 Neutropenia | 5 (3.9) | 2 (1.6) | 85 (36.5) | 47 (20.2) | < 0.001/<0.001 |
 Febrile neutropenia | - | - | 5 (2.1) | 5 (2.1) | 0.166/0.166 |
 Anemia | 77 (60.6) | 15 (11.8) | 166 (71.2) | 51 (21.9) | 0.040/0.018 |
 Thrombocytopenia | 17 (13.4) | 7 (5.5) | 51 (21.9) | 12 (5.2) | 0.049/0.883 |
Non-hematologic | Â | Â | Â | Â | Â |
 Nausea | 7 (5.5) | 1 (0.8) | 45 (19.4) | 18 (7.8) | < 0.001/0.005 |
 Vomiting | 11 (8.7) | 5 (3.9) | 32 (13.7) | 11 (4.7) | 0.156/0.730 |
 Mucositis | 1 (0.8) | - | 7 (3.0) | 1 (0.4) | 0.173/0.999 |
 Diarrhea | 6 (4.7) | 1 (0.8) | 29 (12.4) | 8 (3.4) | 0.018/0.168 |
 Fatigue | 22 (17.3) | 3 (2.4) | 45 (19.3) | 4 (1.7) | 0.643/0.701 |
 AST/ALT elevation | 24 (18.9) | 3 (2.4) | 37 (15.9) | 5 (2.1) | 0.466/0.999 |
 Hypothyroidism | 4 (3.1) | 1 (0.8) | - | - |  |
 Adrenal insufficiency | 2 (1.6) | - | - | - |  |