Table 4.
Summary of ADA incidence (safety population)
| Visit | Criteria | PF-06439535 group (N = 356) | Bevacizumab-EU group (N = 358) |
|---|---|---|---|
| Cycle 1 (prior to treatment) | Number of patients evaluated | 352 | 353 |
| Positive | 1 (0.3) | 3 (0.8) | |
| Negative | 350 (99.4) | 350 (99.2) | |
| Not tested | 1 (0.3) | 0 | |
| Overall (post-treatment)a | Number of patients evaluated | 339 | 350 |
| Positive | 5 (1.5) | 5 (1.4) | |
| Negative | 334 (98.5) | 345 (98.6) |
Data are presented as number (%) of patients unless otherwise specified. Final data after study completion on 22 December 2017. Percentages based on the number of patients evaluated at each visit. All samples taken prior to dosing. ADA-positive sample defined as ADA titer ≥ 2.29, ADA-negative sample defined as ADA titer < 2.29
ADA anti-drug antibody, bevacizumab-EU reference bevacizumab sourced from the European Union, N number of patients who received study drug
aFor calculation of the overall incidence of post-treatment ADA, the denominator was the number of patients with at least one post-cycle 1 ADA sample tested. Patients with a positive ADA sample at any time post-cycle 1 were defined as having an overall positive ADA status