Table 1 Treatment-emergent adverse events (AEs; ≥ 10% of patients), regardless of relationship to study drug.
Category, n (%)a | All patients N = 115 | |
|---|---|---|
All grades | Grade ≥ 3 | |
Number of patients with ≥ 1 event | 115 (100) | 88 (76.5) |
Arthralgia | 47 (40.9) | 3 (2.6) |
Lipase increasedb | 45 (39.1) | 25 (21.7) |
Fatigue | 44 (38.3) | 2 (1.7) |
Headache | 44 (38.3) | 3 (2.6) |
Diarrhea | 38 (33.0) | 0 |
Vomiting | 37 (32.2) | 3 (2.6) |
Nausea | 36 (31.3) | 2 (1.7) |
Hypertension | 35 (30.4) | 21 (18.3) |
Abdominal pain | 32 (27.8) | 1 (0.9) |
Dizziness | 31 (27.0) | 0 |
Upper respiratory tract infection | 31 (27.0) | 1 (0.9) |
COVID-19 | 29 (25.2) | 3 (2.6) |
Rash | 29 (25.2) | 0 |
Pruritus | 27 (23.5) | 1 (0.9) |
Cough | 26 (22.6) | 0 |
Thrombocytopenia | 26 (22.6) | 12 (10.4) |
Amylase increased | 25 (21.7) | 5 (4.3) |
Myalgia | 25 (21.7) | 3 (2.6) |
Constipation | 24 (20.9) | 1 (0.9) |
Back pain | 23 (20.0) | 3 (2.6) |
Pain in extremity | 23 (20.0) | 1 (0.9) |
Upper abdominal pain | 21 (18.3) | 0 |
Anemia | 19 (16.5) | 10 (8.7) |
Peripheral edema | 19 (16.5) | 0 |
Dyspnea | 18 (15.7) | 1 (0.9) |
Increased ALT | 17 (14.8) | 3 (2.6) |
Bone pain | 17 (14.8) | 2 (1.7) |
Nasopharyngitis | 17 (14.8) | 0 |
Pyrexia | 17 (14.8) | 1 (0.9) |
Increased weight | 17 (14.8) | 3 (2.6) |
Neutropenia | 16 (13.9) | 10 (8.7) |
Hyperhidrosis | 15 (13.0) | 0 |
Non-cardiac chest pain | 15 (13.0) | 0 |
Pleural effusion | 15 (13.0) | 4 (3.5) |
Anxiety | 14 (12.2) | 1 (0.9) |
Increased AST | 14 (12.2) | 0 |
Decreased appetite | 14 (12.2) | 0 |
Depression | 14 (12.2) | 0 |
Hypertriglyceridemia | 14 (12.2) | 3 (2.6) |
Oropharyngeal pain | 14 (12.2) | 0 |
Increased blood creatinine | 13 (11.3) | 0 |
Hyperglycemia | 13 (11.3) | 2 (1.7) |
Hyperuricemia | 13 (11.3) | 5 (4.3) |
Insomnia | 13 (11.3) | 1 (0.9) |
Dry eye | 12 (10.4) | 0 |
Fall | 12 (10.4) | 2 (1.7) |
Increased γ-glutamyltransferase | 12 (10.4) | 3 (2.6) |
Hypophosphatemia | 12 (10.4) | 3 (2.6) |
Muscle spasms | 12 (10.4) | 0 |
Pneumonia | 12 (10.4) | 5 (4.3) |