Table 1 Safety results for the post treatment period
HD201 | Herceptin® | |
|---|---|---|
N = 234 | N = 242 | |
Patients presenting with ANY | n (%) | n (%) |
PTAE | 64 (27.4%) | 72 (29.8%) |
PTAE Related to Study Treatment | 21 (9.0%) | 23 (9.5%) |
PTAE ≥ Grade 3 | 7 (3.0%) | 13 (5.4%) |
Serious PTAE | 4 (1.7%) | 5 (2.1%) |
Serious PTAE Related to Study Treatment | 0 (0.0) | 0 (0.0) |
PTAE of Special Interest | 35 (15.0%) | 40 (16.5%) |
PTAE by Preferred Term | ||
Cardiac disorders | 19 (8.1%) | 27 (11.2%) |
Neoplasms benign, malignant, and unspecified (incl. cysts and polyps) | 16 (6.8%) | 14 (5.8%) |
Blood and lymphatic system disorders | 12 (5.1%) | 10 (4.1%) |
PTAEs related to study treatment by preferred term | ||
Cardiac disorders | 12 (5.1%) | 11 (4.5%) |
Blood and lymphatic system disorders | 6 (2.6%) | 1 (0.4%) |