TRAE | 250 mg (n = 3) | 300 mg (n = 25) | 350 mg (n = 53) | Total (n = 81) | ||||
---|---|---|---|---|---|---|---|---|
G-Alla | ≥ G3 | G-All | ≥ G3 | G-All | ≥ G3 | G-All | ≥ G3 | |
Gastrointestinal disorders (n, %) | Â | Â | Â | Â | Â | Â | Â | Â |
Diarrhea | 3 (100) | 0 | 16 (64.0) | 1 (4.0) | 36 (67.9) | 1 (1.9) | 55 (67.9) | 2 (2.5) |
Oral ulcer | 0 | 0 | 4 (16.0) | 0 | 21 (39.6) | 1 (1.9) | 25 (30.9) | 1 (1.2) |
Vomiting | 1 (33.3) | 0 | 8 (32.0) | 1 (4.0) | 11 (20.8) | 0 | 20 (24.7) | 1 (1.2) |
Nausea | 1 (33.3) | 0 | 8 (32.0) | 1 (4.0) | 7 (13.2) | 1 (1.9) | 16 (19.8) | 2 (2.5) |
Oral mucositis | 0 | 0 | 3 (12.0) | 0 | 7 (13.2) | 0 | 10 (12.3) | 0 |
Skin and subcutaneous tissue disorders (n, %) | Â | Â | Â | Â | Â | Â | Â | Â |
Rash | 1 (33.3) | 0 | 10 (40.0) | 0 | 41 (77.4) | 7 (13.2) | 52 (64.2) | 7 (8.6) |
Palmar-plantar erythrodysesthesia syndrome | 1 (33.3) | 1 (33.3) | 7 (28.0) | 1 (4.0) | 24 (45.3) | 2 (3.8) | 32 (39.5) | 4 (4.9) |
Investigations (n, %) | Â | Â | Â | Â | Â | Â | Â | Â |
Elevated AST | 0 | 0 | 4 (16.0) | 0 | 17 (32.1) | 4 (7.5) | 21 (25.9) | 4 (4.9) |
Elevated ALT | 0 | 0 | 5 (20.0) | 0 | 15 (28.3) | 2 (3.8) | 20 (24.7) | 2 (2.5) |
Leukopenia | 0 | 0 | 3 (12.0) | 0 | 6 (11.3) | 0 | 9 (11.1) | 0 |
Metabolism and nutrition disorders (n, %) | Â | Â | Â | Â | Â | Â | Â | Â |
Anorexia | 0 | 0 | 2 (8.0) | 0 | 10 (18.9) | 1 (1.9) | 12 (14.8) | 1 (1.2) |
Hypoalbuminemia | 0 | 0 | 0 | 0 | 12 (22.6) | 0 | 12 (14.8) | 0 |
Infections and infestations (n, %) | Â | Â | Â | Â | Â | Â | Â | Â |
Paronychia | 0 | 0 | 4 (16.0) | 0 | 7 (13.2) | 1 (1.9) | 11 (13.6) | 1 (1.2) |
General disorders and administration site conditions (n, %) | Â | Â | Â | Â | Â | Â | Â | Â |
Fatigue | 0 | 0 | 3 (12.0) | 1 (4.0) | 9 (17.0) | 2 (3.8) | 12 (14.8) | 3 (3.7) |
Blood and lymphatic system disorders (n, %) | Â | Â | Â | Â | Â | Â | Â | Â |
Anemia | 1 (33.3) | 1 (33.3) | 4 (16.0) | 1 (4.0) | 20 (37.7) | 3 (5.7) | 25 (30.9) | 5 (6.2) |
Renal and urinary disorders (n, %) | Â | Â | Â | Â | Â | Â | Â | Â |
Proteinuria | 0 | 0 | 3 (12.0) | 0 | 13 (24.5) | 0 | 16 (19.8) | 0 |