Table 3.
Adverse events occurring in >=10% of patients.
| Subjects - N(%) (Grades 1–2) |
Subjects - N(%) (Grades 3–5) |
|||
|---|---|---|---|---|
| ASC (N = 51) | ASC+vinorelbine (N = 96) | ASC (N = 51) | ASC+vinorelbine (N = 96) | |
| Blood and lymphatic system disorders | ||||
| Anaemia | 5 (10) | 23 (24) | 0 (0) | 0 (0) |
| Lymphopenia | 2 (4) | 12 (12) | 0 (0) | 4 (4) |
| Neutropenia | 0 (0) | 6 (6) | 0 (0) | 12 (12) |
| Gastrointestinal disorders | ||||
| Abdominal pain | 1 (2) | 13 (14) | 0 (0) | 2 (2) |
| Constipation | 4 (8) | 37 (39) | 0 (0) | 1 (1) |
| Diarrhoea | 2 (4) | 24 (25) | 0 (0) | 0 (0) |
| Nausea | 2 (4) | 22 (23) | 0 (0) | 0 (0) |
| General disorders and administration site conditions | ||||
| Fatigue | 11 (22) | 46 (48) | 0 (0) | 4 (4) |
| Chest Pain | 5 (10) | 12 (12) | 0 (0) | 2 (2) |
| Infections and infestations | ||||
| Lower respiratory infection | 3 (6) | 6 (6) | 3 (6) | 5 (5) |
| Metabolism and nutrition disorders | ||||
| Anorexia | 5 (10) | 22 (23) | 0 (0) | 0 (0) |
| Respiratory, thoracic and mediastinal disorders | ||||
| Coughing | 12 (24) | 21 (22) | 0 (0) | 0 (0) |
| Dyspnoea | 9 (18) | 25 (26) | 0 (0) | 6 (6) |