Table 3.
TEAEs (safety population)
| Overall safety population | Subgroup ongoing after day 378a | |||
|---|---|---|---|---|
| PF-05280014 plus paclitaxel (n = 349) | Trastuzumab-EU plus paclitaxel (n = 353) | PF-05280014 plus paclitaxel (n = 265) | Trastuzumab-EU plus paclitaxel (n = 264) | |
| Number of TEAEs | 2692 | 2789 | 446 | 471 |
| Any TEAEs | 344 (98.6) | 341 (96.6) | 107 (40.4) | 112 (42.4) |
| Grade 3 or higher TEAEs | 143 (41.0) | 152 (43.1) | 31 (11.7) | 39 (14.8) |
| Treatment-related TEAEs | 321 (92.0) | 316 (89.5) | 52 (19.6) | 60 (22.7) |
| Trastuzumab-related TEAEs | 130 (37.2) | 119 (33.7) | 35 (13.2) | 39 (14.8) |
| Treatment-related Grade 3 or higher TEAEs | 84 (24.1) | 92 (26.1) | 8 (3.0) | 5 (1.9) |
| Trastuzumab-related Grade 3 or higher TEAEs | 15 (4.3) | 11 (3.1) | 5 (1.9) | 1 (0.4) |
| TEAEs resulting in treatment discontinuation | 57 (16.3) | 52 (14.7) | 10 (3.8) | 12 (4.5) |
| Trastuzumab discontinuation | 24 (6.9) | 20 (5.7) | 8 (3.0) | 8 (3.0) |
| Treatment-related TEAEs resulting in treatment discontinuation | 45 (12.9) | 46 (13.0) | 4 (1.5) | 9 (3.4) |
| Trastuzumab discontinuation | 11 (3.2) | 13 (3.7) | 2 (0.8) | 5 (1.9) |
| Serious TEAEs | 67 (19.2) | 69 (19.5) | 19 (7.2) | 15 (5.7) |
| Treatment-related serious TEAEs | 23 (6.6) | 16 (4.5) | 5 (1.9) | 0 |
| Trastuzumab-related serious TEAEs | 8 (2.3) | 5 (1.4) | 3 (1.1) | 0 |
| Serious TEAEs resulting in treatment discontinuation | 16 (4.6) | 9 (2.5) | 6 (2.3) | 3 (1.1) |
| Trastuzumab discontinuation | 11 (3.2) | 8 (2.3) | 5 (1.9) | 3 (1.1) |
| Treatment-related serious TEAEs resulting in treatment discontinuation | 8 (2.3) | 3 (0.8) | 2 (0.8) | 0 |
| Trastuzumab discontinuation | 2 (0.6) | 2 (0.6) | 1 (0.4) | 0 |
| TEAEs resulting in treatment being temporarily stopped | 153 (43.8) | 159 (45.0) | 32 (12.1) | 29 (11.0) |
| Trastuzumab temporarily stopped | 116 (33.2) | 113 (32.0) | 29 (10.9) | 25 (9.5) |
| TEAEs resulting in trastuzumab infusion rate reduced | 2 (0.6) | 3 (0.8) | 0 | 0 |
Values are number of patients n (%) unless stated otherwise. TEAE 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 defined through last dose of PF-05280014 or trastuzumab-EU + 70 days. Treatment-related: related to trastuzumab and/or paclitaxel; trastuzumab related: related only to trastuzumab; paclitaxel related: related only to paclitaxel. Serious TEAE was recorded according to investigator assessment. Patients discontinued due to adverse events were those who permanently discontinued the study treatment. Except for the ‘Number of TEAEs’ row, patients were only counted once per treatment group per row for the overall safety population, and once per treatment group per row for the subgroup ongoing after day 378
TEAE treatment-emergent adverse event, trastuzumab-EU trastuzumab sourced from the European Union
aFor the subgroup columns, only those TEAEs that started after day 378 are included