Table 2.
TEAEs reported for ≥ 10% of patientsa in either treatment group during the overall study period (safety population)
| System organ class Preferred term |
CT-P6 (n = 271) |
Trastuzumab (n = 278) |
|---|---|---|
| Total number of TEAEs | 2897 | 3136 |
| Patients with ≥ 1 TEAE | 263 (97.0) | 265 (95.3) |
| Blood and lymphatic system disorders | 132 (48.7) | 155 (55.8) |
| Anemia | 60 (22.1) | 67 (24.1) |
| Leukopenia | 28 (10.3) | 40 (14.4) |
| Neutropenia | 96 (35.4) | 116 (41.7) |
| Cardiac disorders | 32 (11.8) | 39 (14.0) |
| Cardiac failurea | 1 (0.4) | 0 |
| Cardiotoxicitya | 1 (0.4) | 1 (0.4) |
| Congestive cardiomyopathya | 0 | 1 (0.4) |
| Supraventricular tachycardiaa | 1 (0.4) | 0 |
| Gastrointestinal disorders | 135 (49.8) | 149 (53.6) |
| Diarrhea | 52 (19.2) | 50 (18.0) |
| Nausea | 99 (36.5) | 94 (33.8) |
| Stomatitis | 46 (17.0) | 33 (11.9) |
| Vomiting | 27 (10.0) | 26 (9.4) |
| General disorders and administration-site conditions | 125 (46.1) | 126 (45.3) |
| Asthenia | 47 (17.3) | 38 (13.7) |
| Fatigue | 53 (19.6) | 62 (22.3) |
| Pyrexia | 31 (11.4) | 30 (10.8) |
| Injury, poisoning, and procedural complications | 75 (27.7) | 76 (27.3) |
| Infusion-related reaction | 31 (11.4) | 29 (10.4) |
| Radiation skin injury | 33 (12.2) | 34 (12.2) |
| Investigations | 68 (25.1) | 69 (24.8) |
| Alanine aminotransferase increased | 18 (6.6) | 30 (10.8) |
| Ejection fraction abnormala | 0 | 1 (0.4) |
| Ejection fraction decreaseda | 20 (7.4) | 9 (3.2) |
| Musculoskeletal and connective tissue disorders | 76 (28.0) | 86 (30.9) |
| Arthralgia | 34 (12.5) | 40 (14.4) |
| Myalgia | 27 (10.0) | 28 (10.1) |
| Skin and subcutaneous tissue disorders | 210 (77.5) | 224 (80.6) |
| Alopecia | 196 (72.3) | 213 (76.6) |
Data are n (%) of patients other than for the total number of TEAEs
aTEAEs captured for heart failure under the system organ classes of cardiac disorders or investigations are presented regardless of frequency
TEAE treatment-emergent adverse event