Table 2.
Incidence of all-grade TRAEs ≥ 10% and grade 3 or higher TRAEs ≥ 3%
| TEAE, n (%) | Safety population (n = 150) | B2 cohort (n = 121) | ||
|---|---|---|---|---|
| All grade | Grade ≥ 3 | All grade | Grade ≥ 3 | |
| Any | 147 (98.0) | 93 (62.0) | 119 (98.3) | 79 (65.3) |
| Rash | 118 (78.7) | 32 (21.3) | 96 (79.3) | 26 (21.5) |
| Diarrhea | 98 (65.3) | 16 (10.7) | 80 (66.1) | 14 (11.6) |
| Dry skin | 88 (58.7) | 7 (4.7) | 67 (55.4) | 5 (4.1) |
| Decreased appetite | 85 (56.7) | 4 (2.7) | 67 (55.4) | 3 (2.5) |
| Paronychia | 81 (54.0) | 3 (2.0) | 64 (52.9) | 2 (1.7) |
| AST increased | 57 (38.0) | 2 (1.3) | 44 (36.4) | 2 (1.7) |
| ALT increased | 54 (36.0) | 0 | 44 (36.4) | 0 |
| Weight decreased | 52 (34.7) | 6 (4.0) | 50 (41.3) | 6 (5.0) |
| Vomiting | 50 (33.3) | 3 (2.0) | 39 (32.2) | 3 (2.5) |
| Oral mucositis | 47 (31.3) | 4 (2.7) | 37 (30.6) | 3 (2.5) |
| Nausea | 43 (28.7) | 1 (0.8) | 36 (29.8) | 1 (0.7) |
| Pruritus | 42 (28.0) | 2 (1.3) | 29 (24.0) | 2 (1.7) |
| Anemia | 40 (26.7) | 5 (3.3) | 33 (27.3) | 4 (3.3) |
| Malaise | 39 (26.0) | 5 (3.3) | 29 (24.0) | 5 (4.1) |
| White blood cell decreased | 37 (24.7) | 4 (2.7) | 33 (27.3) | 4 (3.3) |
| Platelet count decreased | 36 (24.0) | 7 (4.7) | 35 (28.9) | 6 (5.0) |
| Hypoalbuminemia | 36 (24.0) | 0 | 28 (23.1) | 0 |
| Neutrophil count decreased | 29 (19.3) | 8 (5.3) | 28 (23.1) | 8 (6.6) |
| Fever | 29 (19.3) | 0 | 21 (17.4) | 0 |
| Skin hypopigmentation | 29 (19.3) | 0 | 21 (17.4) | 0 |
| Dizziness | 26 (17.3) | 0 | 18 (14.9) | 0 |
| Hyponatremia | 24 (16.0) | 1 (0.7) | 20 (16.5) | 1 (0.8) |
| Proteinuria | 22 (14.7) | 0 | 21 (17.4) | 0 |
| Stomal ulcer | 22 (14.7) | 0 | 20 (16.5) | 0 |
| Hypokalemia | 21 (14.0) | 2 (1.3) | 10 (8.3) | 0 |
| CPK increased | 20 (13.3) | 5 (3.3) | 20 (16.5) | 5 (4.1) |
| Headache | 19 (12.7) | 1 (0.7) | 12 (9.9) | 1 (0.8) |
| Skin fissures | 18 (12.0) | 0 | 16 (13.2) | 0 |
| QT interval prolonged | 16 (10.7) | 0 | 16 (13.2) | 0 |
| Blood LDH increased | 16 (10.7) | 0 | 14 (11.6) | 0 |
| Blood creatinine increased | 16 (10.7) | 0 | 13 (10.7) | 0 |
| Hypocalcemia | 15 (10.0) | 0 | 14 (11.6) | 0 |
TRAEs treatment-related adverse events, AST aspartate aminotransferase, ALT alanine aminotransferase, CPK creatine phosphate kinase, LDH lactate dehydrogenase.