Table 3.
Summary of adverse events at 1 yeara (safety population)
| CT-P6 (N = 271) | Trastuzumab (N = 278) | |
|---|---|---|
| Overview of TEAEs | ||
| Total number of TEAEs | 2880 | 3130 |
| Patients experiencing ≥ 1 TEAEs | 263 (97.0) | 265 (95.3) |
| Grade 1 or 2 | 158 (58.3) | 153 (55.0) |
| Grade ≥ 3 | 105 (38.7) | 112 (40.3) |
| Treatment relatedb | 129 (47.6) | 145 (52.2) |
| Total number of treatment-emergent SAEs | 26 | 46 |
| Patients experiencing ≥ 1 treatment-emergent SAEs | 20 (7.4) | 33 (11.9) |
| Grade 1 or 2 | 3 (1.1) | 6 (2.2) |
| Grade ≥ 3 | 17 (6.3) | 27 (9.7) |
| Treatment related | 5 (1.8) | 8 (2.9) |
| TEAEs leading to discontinuation | 11 (4.1) | 13 (4.7) |
| TEAEs leading to death | 2 (0.7) | 2 (0.7) |
| TEAEs of special interest | ||
| Cardiac disorders | 30 (11.1) | 37 (13.3) |
| Treatment related | 20 (7.4) | 24 (8.6) |
| Infusion-related reactions | 31 (11.4) | 29 (10.4) |
| Treatment related | 22 (8.1) | 18 (6.5) |
| Treatment-related TEAEs reported in ≥ 5% of either treatment group | ||
| Alanine aminotransferase increased | 4 (1.5) | 16 (5.8) |
| Alopecia | 21 (7.7) | 25 (9.0) |
| Anaemia | 11 (4.1) | 26 (9.4) |
| Aspartate aminotransferase increased | 2 (0.7) | 15 (5.4) |
| Asthenia | 24 (8.9) | 22 (7.9) |
| Diarrhoea | 14 (5.2) | 12 (4.3) |
| Ejection fraction decreased | 19 (7.0) | 9 (3.2) |
| Infusion-related reaction | 22 (8.1) | 18 (6.5) |
| Leukopenia | 7 (2.6) | 18 (6.5) |
| Nausea | 15 (5.5) | 20 (7.2) |
| Neutropenia | 19 (7.0) | 35 (12.6) |
| Rash | 25 (9.2) | 11 (4.0) |
Data are n or n (%). The total number of TEAEs includes all patient events. At each level of summarisation, a patient was counted once if the patient reported one or more events. Only the most severe event is counted
SAE serious adverse event, TEAE treatment-emergent adverse event
aNeoadjuvant period, surgery, and adjuvant period, or at least 1 year (including follow-up) from the first administration of study drug in the neoadjuvant period in patients who discontinued treatment early without completing the adjuvant phase
bTEAEs were considered to be related to study drug if the relationship was defined as ‘possible’, ‘probable’, or ‘definite’