Table 4.
Any grade adverse events occurring in ≥10% of patients and the incidence of these that were grade 3 or 4 within indicated categories (Safety population)
| BTH1677 (N = 59) | Control (N = 29) | |||
|---|---|---|---|---|
| Adverse Events (AEs), n (%) | All AEs | Grade 3 or Grade 4 AEs | All AEs | Grade 3 or Grade 4 AEs |
| Number of patients with at least 1 AE | 59 (100.0) | 46 (78.0) | 29 (100.0) | 25 (86.2) |
| Blood and lymphatic system disorders | ||||
| Neutropenia | 22 (37.3) | 19 (32.2) | 15 (51.7) | 14 (48.3) |
| Leukopenia | 13 (22.0) | 9 (15.3) | 9 (31.0) | 9 (31.0) |
| Anemia | 5 (8.5) | 3 (5.1) | 8 (27.6) | 2 (6.9) |
| Thrombocytopenia | 6 (10.2) | 2 (3.4) | 5 (17.2) | 2 (6.9) |
| Gastrointestinal disorders | ||||
| Nausea | 25 (42.4) | 0 | 12 (41.4) | 1 (3.4) |
| Diarrhea | 24 (40.7) | 0 | 9 (31.0) | 3 (10.3) |
| Constipation | 11 (18.6) | 0 | 10 (34.5) | 0 |
| Vomiting | 11 (18.6) | 0 | 5 (17.2) | 0 |
| Abdominal pain | 6 (10.2) | 2 (3.4) | 4 (13.8) | 0 |
| Stomatitis | 4 (6.8) | 0 | 4 (13.8) | 0 |
| General disorders and administration site conditions | ||||
| Fatigue | 30 (50.8) | 4 (6.8) | 17 (58.6) | 0 |
| Mucosal inflammation | 13 (22.0) | 0 | 6 (20.7) | 1 (3.4) |
| Chest pain | 10 (16.9) | 0 | 5 (17.2) | 1 (3.4) |
| Chills | 9 (15.3) | 2 (3.4) | 4 (13.8) | 1 (3.4) |
| Pyrexia | 4 (6.8) | 0 | 8 (27.6) | 1 (3.4) |
| Edema peripheral | 5 (8.5) | 0 | 5 (17.2) | 0 |
| Asthenia | 3 (5.1) | 0 | 4 (13.8) | 1 (3.4) |
| Chest discomfort | 1 (1.7) | 0 | 3 (10.3) | 0 |
| Immune disorders | ||||
| Hypersensitivity | 4 (6.8) | 2 (3.4) | 3 (10.3) | 0 |
| Infections and infestations | ||||
| Nasopharyngitis | 6 (10.2) | 0 | 3 (10.3) | 0 |
| Paronychia | 6 (10.2) | 0 | 2 (6.9) | 0 |
| Investigations | ||||
| White blood cell count decreased | 0 | 0 | 3 (10.3) | 2 (6.9) |
| Metabolism and nutritional disorders | ||||
| Decreased appetite | 13 (22.0) | 1 (1.7) | 7 (24.1) | 1 (3.4) |
| Hypokalaemia | 6 (10.2) | 3 (5.1) | 3 (10.3) | 1 (3.4) |
| Hypomagnesemia | 6 (10.2) | 1 (1.7) | 2 (6.9) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 11 (18.6) | 0 | 6 (20.7) | 1 (3.4) |
| Pain in extremity | 10 (16.9) | 1 (1.7) | 5 (17.2) | 0 |
| Bone pain | 6 (10.2) | 0 | 5 (17.2) | 0 |
| Arthralgia | 6 (10.2) | 0 | 4 (13.8) | 0 |
| Back pain | 5 (8.5) | 0 | 3 (10.3) | 1 (3.4) |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | ||||
| Tumor pain | 2 (3.4) | 0 | 3 (10.3) | 0 |
| Nervous system disorders | ||||
| Polyneuropathy | 16 (27.1) | 4 (6.8) | 9 (31.0) | 2 (6.9) |
| Paresthesia | 7 (11.9) | 0 | 9 (31.0) | 0 |
| Dizziness | 8 (13.6) | 0 | 6 (20.7) | 0 |
| Headache | 7 (11.9) | 0 | 4 (13.8) | 0 |
| Dysgeusia | 5 (8.5) | 0 | 5 (17.2) | 0 |
| Peripheral sensory neuropathy | 0 | 0 | 3 (10.3) | 0 |
| Psychiatric disorders | ||||
| Insomnia | 7 (11.9) | 0 | 5 (17.2) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 12 (20.3) | 0 | 11 (37.9) | 0 |
| Dyspnea | 12 (20.3) | 1 (1.7) | 10 (34.5) | 1 (3.4) |
| Dysphonia | 6 (10.2) | 1 (1.7) | 6 (20.7) | 0 |
| Epistaxis | 7 (11.9) | 0 | 5 (17.2) | 0 |
| Pleural effusion | 7 (11.9) | 3 (5.1) | 3 (10.3) | 0 |
| Oropharyngeal pain | 3 (5.1) | 0 | 3 (10.3) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Rash | 28 (47.5) | 2 (3.4) | 19 (65.5) | 3 (10.3) |
| Alopecia | 22 (37.3) | 0 | 13 (44.8) | 0 |
| Dermatitis | 12 (20.3) | 0 | 5 (17.2) | 0 |
| Pruritus | 9 (15.3) | 1 (1.7) | 4 (13.8) | 1 (3.4) |
| Skin fissures | 11 (18.6) | 0 | 2 (6.9) | 0 |
| Dry skin | 6 (10.2) | 0 | 3 (10.3) | 0 |