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) |
“Trastuzumab” refers to PF-05280014 or trastuzumab-EU.
ALT alanine aminotransferase, MedDRA Medical Dictionary for Regulatory Activities, TEAE treatment-emergent adverse event, trastuzumab-EU reference trastuzumab sourced from the European Union
aTEAE was defined as any event that occurred on or after the first dose of study treatment administration or any pre-existing event that worsened in severity after dosing. TEAE was defined through last dose of trastuzumab + 70 days. For number of TEAEs, the event of “infusion-related reaction” was counted; however, the number of associated signs and symptoms of infusion-related reactions was counted separately (data not presented)
bSerious TEAE determined by investigator’s assessment of serious
cTEAEs presented in descending order of frequency based on incidence in the total safety population. Patients are only counted once per treatment for each row. MedDRA (v19.1) coding dictionary applied