Table 5.
Treatment-emergent, all-causality adverse events occurring in ≥5% of all subjects
| PF-05280014 (n = 35) | Trastuzumab-EU (n = 35) | Trastuzumab-US (n = 35) | |
|---|---|---|---|
| Subjects with any AE, n (%) | 28 (80.0) | 29 (82.9) | 29 (82.9) |
| Eye disorders, n (%) | |||
| Conjunctival hyperaemia | 4 (11.4) | 1 (2.9) | 2 (5.7) |
| Gastrointestinal disorders, n (%) | |||
| Diarrhoea | 3 (8.6) | 2 (5.7) | 1 (2.9) |
| Nausea | 5 (14.3) | 5 (14.3) | 3 (8.6) |
| General disorders and administration site conditions, n (%) | |||
| Pyrexia | 10 (28.6) | 3 (8.6) | 2 (5.7) |
| Chills | 9 (25.7) | 7 (20.0) | 5 (14.3) |
| Fatigue | 3 (8.6) | 3 (8.6) | 3 (8.6) |
| Infections and infestations, n (%) | |||
| Nasopharyngitis | 3 (8.6) | 3 (8.6) | 2 (5.7) |
| Pharyngitis | 1 (2.9) | 4 (11.4) | 2 (5.7) |
| Injury, poisoning and procedural complications, n (%) | |||
| Infusion-related reaction | 13 (37.1) | 10 (28.6) | 7 (20.0) |
| Musculoskeletal and connective tissue disorders, n (%) | |||
| Myalgia | 2 (5.7) | 2 (5.7) | 2 (5.7) |
| Nervous system disorders, n (%) | |||
| Headache | 10 (28.6) | 12 (34.3) | 8 (22.9) |
| Dizziness | 1 (2.9) | 4 (11.4) | 2 (5.7) |
| Respiratory, thoracic and mediastinal disorders, n (%) | |||
| Cough | 1 (2.9) | 4 (11.4) | 1 (2.9) |
AE, adverse event.