Table 3 TEAEs in the safety analysis set
Event, n (%) | Cohort 4A + 4B (n = 77) | |
|---|---|---|
Any grade | 76 (98.7) | |
Grade ≥3 | 51 (66.2) | |
Serious | 29 (37.7) | |
Leading to discontinuation of any drug | 38 (49.4) | |
TEAEs in ≥10% of patients by preferred terms | Any grade | Grade ≥3 |
Nausea | 62 (80.5) | 0 |
Decreased appetite | 56 (72.7) | 6 (7.8) |
Neutrophil count decreased | 35 (45.5) | 25 (32.5) |
Peripheral sensory neuropathy | 35 (45.5) | 2 (2.6) |
Vomiting | 29 (37.7) | 3 (3.9) |
Diarrhea | 28 (36.4) | 1 (1.3) |
Pyrexia | 24 (31.2) | 0 |
Anemia | 19 (24.7) | 2 (2.6) |
Constipation | 17 (22.1) | 0 |
Asthenia | 15 (19.5) | 1 (1.3) |
Abdominal pain upper | 13 (16.9) | 0 |
Aspartate aminotransferase increased | 13 (16.9) | 2 (2.6) |
Stomatitis | 13 (16.9) | 1 (1.3) |
Alanine aminotransferase increased | 11 (14.3) | 2 (2.6) |
Edema peripheral | 11 (14.3) | 0 |
Abdominal pain | 10 (13.0) | 0 |
Dysgeusia | 10 (13.0) | 0 |
White blood cell count decreased | 10 (13.0) | 5 (6.5) |
Gastritis | 9 (11.7) | 0 |
Paresthesia | 9 (11.7) | 0 |
Platelet count decreased | 9 (11.7) | 2 (2.6) |
Rash | 9 (11.7) | 0 |
Weight decreased | 9 (11.7) | 0 |
COVID-19 | 8 (10.4) | 0 |
Hepatic function abnormal | 8 (10.4) | 2 (2.6) |
Hypoalbuminemia | 8 (10.4) | 5 (6.5) |
Malaise | 8 (10.4) | 0 |
Neutropenia | 8 (10.4) | 5 (6.5) |
