Table 3 Summary of treatment-emergent adverse events (safety population) – Week 53 analysis
PF-05280014 plus paclitaxel (n = 349) | Trastuzumab-EU plus paclitaxel (n = 353) | Total (N = 702) | |
|---|---|---|---|
Number of TEAEsa | 2336 | 2436 | 4772 |
Patients with event, n (%) | |||
Any TEAEs | 337 (96.6) | 339 (96.0) | 676 (96.3) |
Grade 3 or higher TEAEs | 120 (34.4) | 129 (36.5) | 249 (35.5) |
Serious TEAEsb | 53 (15.2) | 56 (15.9) | 109 (15.5) |
Trastuzumab-related TEAEs | 104 (29.8) | 101 (28.6) | 205 (29.2) |
Trastuzumab-related Grade 3 or higher TEAEs | 9 (2.6) | 11 (3.1) | 20 (2.8) |
Trastuzumab-related serious TEAEs | 5 (1.4) | 5 (1.4) | 10 (1.4) |
TEAEs resulting in permanent discontinuation of trastuzumab | 16 (4.6) | 12 (3.4) | 28 (4.0) |
TEAEs with incidence ≥ 10% in either treatment group,c n (%) | |||
Alopecia | 189 (54.2) | 185 (52.4) | 374 (53.3) |
Anaemia | 120 (34.4) | 131 (37.1) | 251 (35.8) |
Neutropenia | 99 (28.4) | 91 (25.8) | 190 (27.1) |
Peripheral sensory neuropathy | 93 (26.6) | 83 (23.5) | 176 (25.1) |
Diarrhoea | 56 (16.0) | 66 (18.7) | 122 (17.4) |
Nausea | 53 (15.2) | 64 (18.1) | 117 (16.7) |
Asthenia | 50 (14.3) | 43 (12.2) | 93 (13.2) |
Fatigue | 44 (12.6) | 49 (13.9) | 93 (13.2) |
Headache | 41 (11.7) | 52 (14.7) | 93 (13.2) |
Leukopenia | 36 (10.3) | 41 (11.6) | 77 (11.0) |
Arthralgia | 41 (11.7) | 36 (10.2) | 77 (11.0) |
ALT increased | 33 (9.5) | 41 (11.6) | 74 (10.5) |
Ejection fraction decreased | 35 (10.0) | 39 (11.0) | 74 (10.5) |
Upper respiratory tract infection | 30 (8.6) | 40 (11.3) | 70 (10.0) |
Oedema peripheral | 24 (6.9) | 43 (12.2) | 67 (9.5) |
