Table 5 Incidence of ADAs by visit and overall (safety population)a
Visit | ADA status | PF-05280014 | Trastuzumab-EU |
|---|---|---|---|
Cycle 1 | Patients assessed, n | 113 | 112 |
Negative < 1.00, n (%) | 113 (100.00) | 110 (98.21) | |
Positive ≥ 1.00, n (%) | 0 | 1 (0.89) | |
Not analysed, n (%) | 0 | 1 (0.89) | |
Cycle 2 | Patients assessed, n | 111 | 112 |
Negative < 1.00, n (%) | 111 (100.00) | 112 (100.00) | |
Positive ≥ 1.00, n (%) | 0 | 0 | |
Cycle 4 | Patients assessed, n | 108 | 109 |
Negative < 1.00, n (%) | 108 (100.00) | 109 (100.00) | |
Positive ≥ 1.00, n (%) | 0 | 0 | |
Cycle 6 | Patients assessed, n | 108 | 108 |
Negative < 1.00, n (%) | 108 (100.00) | 108 (100.00) | |
Positive ≥ 1.00, n (%) | 0 | 0 | |
Overall | Patients assessed, n | 113 | 112 |
Negative < 1.00, n (%) | 113 (100.00) | 111 (99.11) | |
Positive ≥ 1.00, n (%) | 0 | 1 (0.89) |