Table 2.
Primary AEs observed in patients
| AE | Total AEs (N = 279) | Grade 1-2 (n = 155) (55.5%) | Grade 3-4 (n = 124) (44.5%) | SAEs (n = 56) |
|---|---|---|---|---|
| Hematologic | 82 (29.4) | 24 (8.6) | 58 (20.8) | 2 (3.6) |
| Neutropenia | 54 (19.4) | 9 (3.2) | 45 (16.1) | 1 (1.8) |
| Anemia | 16 (5.7) | 9 (3.2) | 7 (2.5) | 1 (1.8) |
| Thrombocytopenia | 12 (4.3) | 6 (2.2) | 6 (2.2) | 0 |
| Nonhematologic | 197 (70.6) | 131 (46.9) | 66 (23.6) | 54 (96.4) |
| Diarrhea | 24 (8.5) | 9 (3.2) | 15 (5.3) | 12 (21.4) |
| Hepatic cytolysis | 26 (9.3) | 7 (2.5) | 19 (6.8) | 4 (7.1) |
| Infections | 52 (18.6) | 44 (15.7) | 8 (2.8) | 13 (23.2) |
| Skin | 16 (5.7) | 11 (3.9) | 5 (1.8) | 3 (5.3) |
| IRR | 15 (5.4) | 15 (5.3) | 0 | 1 (1.8) |
| Others | 64 (22.9) | 45 (16.4) | 19 (6.8) | 21 (37.5) |
Only AEs with rates ≥ 5% are reported. Some patients exhibited grade 1-2 and grade 3-4 AEs, so that patient numbers do not add up to the total by row. Eight other malignancies were observed: 5 skin cancer (3 basocellular, 2 epidermoid), 1 prostatic adenocarcinoma, 1 myelodysplastic syndrome, and 1 glioblastoma.
IRR, infusion-related reaction.