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 |