| 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) |