TABLE 4.
Summary of treatment‐emergent adverse events
| Subjects presenting with any: | HD201 | EU‐Herceptin® | US‐Herceptin® | |||
|---|---|---|---|---|---|---|
| N = 35 | N = 35 | N = 35 | ||||
| n | % | n | % | n | % | |
| TEAE | 27 | 77.1 | 30 | 85.7 | 29 | 82.9 |
| Treatment‐related TEAE | 18 | 51.4 | 23 | 65.7 | 24 | 68.6 |
| Treatment‐emergent SAE | – | – | 1 | 2.9 | – | – |
| Treatment‐related, treatment‐emergent SAE | – | – | – | – | – | – |
| TEAE of severity | ||||||
| Mild | 27 | 77.1 | 29 | 82.9 | 28 | 80.0 |
| Moderate | 1 | 2.9 | 9 | 25.7 | 6 | 17.1 |
| Severe | – | – | – | – | – | – |
| TEAE leading to study discontinuation | – | – | – | – | – | – |
| TEAE of special interest | 7 | 20.0 | 12 | 34.3 | 11 | 31.4 |
Analysis performed on the safety population; TEAE, treatment‐emergent adverse event; SAE, serious adverse event; N, number of subjects in the group; n, number of subjects with event.