Any grade AEs (≥10%) and corresponding Grade 3 or 4 AEs (Safety population)
| BTH1677/Bevacizumab/Carboplatin/Paclitaxel(N = 59) | Bevacizumab/Carboplatin/Paclitaxel(N = 30) | |||
|---|---|---|---|---|
| Adverse events (AEs), n (%) | All AEs | Grade 3 or Grade 4 AEs | All AEs | Grade 3 or Grade 4 AEs |
| Patients with at least 1 AE | 58 (98.3) | 55 (93.2) | 30 (100.0) | 20 (66.7) |
| Blood and lymphatic system disorders | ||||
| Neutropenia | 26 (44.1) | 23 (39.0) | 10 (33.3) | 8 (26.7) |
| Thrombocytopenia | 20 (33.9) | 11 (18.6) | 10 (33.3) | 5 (16.7) |
| Anemia | 14 (23.7) | 2 (3.4) | 8 (26.7) | 1 (3.3) |
| Leukopenia | 9 (15.3) | 3 (5.1) | 2 (6.7) | 1 (3.3) |
| Gastrointestinal disorders | ||||
| Nausea | 40 (67.8) | 5 (8.5) | 16 (53.3) | 0 |
| Constipation | 25 (42.4) | 0 | 9 (30.0) | 0 |
| Vomiting | 19 (32.2) | 2 (3.4) | 7 (23.3) | 0 |
| Diarrhea | 12 (20.3) | 2 (3.4) | 8 (26.7) | 1 (3.3) |
| Abdominal pain upper | 6 (10.2) | 1 (1.7) | 1 (3.3) | 0 |
| Stomatitis | 6 (10.2) | 1 (1.7) | 0 | 0 |
| General disorders and administration-site conditions | ||||
| Fatigue | 33 (55.9) | 1 (1.7) | 18 (60.0) | 1 (3.3) |
| Pyrexia | 12 (20.3) | 2 (3.4) | 3 (10.0) | 0 |
| Chills | 11 (18.6) | 1 (1.7) | 0 | 0 |
| Mucosal inflammation | 6 (10.2) | 0 | 3 (10.0) | 0 |
| Chest pain | 3 (5.1) | 0 | 5 (16.7) | 0 |
| Infections and infestations | ||||
| Nasopharyngitis | 6 (10.2) | 0 | 3 (10.0) | 0 |
| Urinary tract infection | 2 (3.4) | 1 (1.7) | 3 (10.0) | 0 |
| Injury, poisoning, and procedural complications | ||||
| Infusion-related reaction | 7 (11.9) | 1 (1.7) | 2 (6.7) | 1 (3.3) |
| Investigations | ||||
| Hemoglobin decreased | 4 (6.8) | 1 (1.7) | 3 (10.0) | 2 (6.7) |
| Platelet count decreased | 3 (5.1) | 2 (3.4) | 3 (10.0) | 1 (3.3) |
| Metabolism and nutritional disorders | ||||
| Decreased appetite | 17 (28.8) | 1 (1.7) | 11 (36.7) | 0 |
| Hypokalemia | 6 (10.2) | 1 (1.7) | 0 | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 19 (32.2) | 1 (1.7) | 6 (20.0) | 0 |
| Pain in extremity | 15 (25.4) | 0 | 3 (10.0) | 0 |
| Back pain | 11 (18.6) | 1 (1.7) | 4 (13.3) | 0 |
| Myalgia | 12 (20.3) | 1 (1.7) | 2 (6.7) | 0 |
| Nervous system disorders | ||||
| Polyneuropathy | 16 (27.1) | 3 (5.1) | 6 (20.0) | 0 |
| Headache | 9 (15.3) | 1 (1.7) | 4 (13.3) | 0 |
| Neuropathy peripheral | 6 (10.2) | 0 | 5 (16.7) | 0 |
| Dizziness | 7 (11.9) | 0 | 3 (10.0) | 0 |
| Paresthesia | 7 (11.9) | 0 | 2 (6.7) | 0 |
| Dysgeusia | 6 (10.2) | 0 | 2 (6.7) | 0 |
| Psychiatric disorders | ||||
| Insomnia | 9 (15.3) | 0 | 2 (6.7) | 0 |
| Sleep disorder | 5 (8.5) | 0 | 4 (13.3) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnea | 18 (30.5) | 3 (5.1) | 8 (26.7) | 0 |
| Cough | 18 (30.5) | 2 (3.4) | 7 (23.3) | 0 |
| Epistaxis | 14 (23.7) | 0 | 10 (33.3) | 0 |
| Oropharyngeal pain | 8 (13.6) | 0 | 2 (6.7) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 28 (47.5) | 2 (3.4) | 14 (46.7) | 0 |
| Vascular disorders | ||||
| Hypertension | 14 (23.7) | 3 (5.1) | 7 (23.3) | 1 (3.3) |
Abbreviations: AE adverse events, N overall sample size, n number of patients