Table 2 Treatment-related Adverse Events (SS*)
Preferred Term | No. (%) | |||
|---|---|---|---|---|
Phase 1 (N = 160) | Phase 2 (N = 48) | |||
All | ≥ Grade 3 | All | ≥ Grade 3 | |
Any | 157 (98.1) | 64 (40.0) | 46 (95.8) | 30 (62.5) |
Diarrhea | 122 (76.3) | 11 (6.9) | 35 (72.9) | 5 (10.4) |
Rash | 90 (56.3) | 9 (5.6) | 29 (60.4) | 1 (2.1) |
Prolonged QT interval | 79 (49.4) | 24 (15.0) | 20 (41.7) | 14 (29.2) |
Proteinuria | 48 (30.0) | 0 | 16 (33.3) | 0 |
ALT increased | 54 (33.8) | 2 (1.3) | 20 (41.7) | 2 (4.2) |
AST increased | 52 (32.5) | 3 (1.9) | 19 (39.6) | 1 (2.1) |
Hypokalemia | 27 (16.9) | 4 (2.5) | 8 (16.7) | 3 (6.3) |
Blood creatinine increased | 36 (22.5) | 2 (1.3) | 8 (16.7) | 0 |
Nausea | 40 (25.0) | 2 (1.3) | 3 (6.3) | 0 |
Vomiting | 32 (20.0) | 2 (1.3) | 5 (10.4) | 0 |
Hypoalbuminemia | 21 (13.1) | 1 (0.6) | 4 (8.3) | 0 |
Decreased appetite | 28 (17.5) | 3 (1.9) | 4 (8.3) | 1 (2.1) |
Asthenia | 22 (13.8) | 0 | 6 (12.5) | 0 |
Anemia | 14 (8.8) | 1 (0.6) | 5 (10.4) | 0 |
Fecal occult blood positive | 10 (6.3) | 0 | 0 | 0 |
Hypertriglyceridemia | 13 (8.1) | 0 | 5 (10.4) | 0 |
Hypertension | 17 (10.6) | 6 (3.8) | 10 (20.8) | 8 (16.7) |
White blood cell count decreased | 13 (8.1) | 2 (1.3) | 8 (16.7) | 1 (2.1) |
Blood ALP increased | 14 (8.8) | 0 | 5 (10.4) | 0 |
Dizziness | 10 (6.3) | 0 | 3 (1.9) | 0 |
Neutrophil count decreased | 13 (8.1) | 2 (1.3) | 7 (14.6) | 2 (4.2) |
Platelet count decreased | 13 (8.1) | 1 (0.6) | 6 (12.5) | 0 |
Hyponatremia | 10 (6.3) | 1 (0.6) | 6 (12.5) | 0 |
GGT increased | 13 (8.1) | 3 (1.9) | 6 (12.5) | 0 |
Sinus tachycardia | 8 (5.0) | 0 | 5 (10.4) | 0 |
Cough | 2 (1.3) | 0 | 0 | 0 |
Weight loss | 7 (4.4) | 0 | 5 (10.4) | 0 |
Electrocardiogram T wave abnormal | 9 (5.6) | 0 | 0 | 0 |
COVID-19 | 0 | 0 | 0 | 0 |
Urinary tract infection | 2 (1.3) | 0 | 0 | 0 |
