Table 4.
TEAEs by system organ class reported during the follow-up period (safety population)
| System organ class Preferred term |
CT-P6 (n = 271) |
Trastuzumab (n = 278) |
|---|---|---|
| Cardiac disorders | 3 (1.1) | 3 (1.1) |
| Adams–Stokes syndrome | 1 (0.4) | 0 |
| Left ventricular hypertrophy | 0 | 1 (0.4) |
| Mitral valve disease | 0 | 1 (0.4) |
| Myocardial infarction | 0 | 1 (0.4) |
| Palpitations | 1 (0.4) | 0 |
| Pericardial effusion | 1 (0.4) | 0 |
| Ventricular extrasystoles | 1 (0.4) | 0 |
| Eye disorders | 0 | 1 (0.4) |
| Dacryostenosis acquired | 0 | 1 (0.4) |
| Gastrointestinal disorders | 0 | 1 (0.4) |
| Abdominal pain | 0 | 1 (0.4) |
| Infections and infestations | 1 (0.4) | 0 |
| Nasopharyngitis | 1 (0.4) | 0 |
| Investigations | 3 (1.1) | 1 (0.4) |
| Ejection fraction decreased | 3 (1.1) | 0 |
| Electrocardiogram QT prolonged | 0 | 1 (0.4) |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 1 (0.4) | 0 |
| Breast adenoma | 1 (0.4) | 0 |
Data are n (%) of patients
TEAE treatment-emergent adverse event