Table 3. Safety Results for the Neoadjuvant, Adjuvant, and Overall Periods.
| Characteristic | Participants with TEAEs, No. (%)a | |||||
|---|---|---|---|---|---|---|
| Neoadjuvant period (SAF) | Adjuvant period (aSAF) | Entire period (SAF) | ||||
| HD201 | Referent trastuzumab | HD201 | Referent trastuzumab | HD201 | Referent trastuzumab | |
| Participants in the analysis set, No. | 250 | 252 | 238 | 242 | 250 | 252 |
| TEAE | ||||||
| Any | 246 (98.4) | 243 (96.4) | 164 (68.9) | 167 (69.0) | 250 (100) | 247 (98.0) |
| Related to study treatment | 85 (34.0) | 90 (35.7) | 74 (31.1) | 72 (29.8) | 127 (50.8) | 136 (54.0) |
| Related to chemotherapy | 243 (97.2) | 238 (94.4) | NA | NA | NA | NA |
| ≥Grade 3 | 76 (30.4) | 65 (25.8) | 15 (6.3) | 8 (3.3) | 86 (34.4) | 70 (27.8) |
| Serious | ||||||
| TEAE | 16 (6.4) | 12 (4.8) | 8 (3.4) | 6 (2.5) | 24 (9.6) | 17 (6.7) |
| Related to study treatment | 0 | 1 (0.4) | 1 (0.4) | 2 (0.8) | 1 (0.4) | 3 (1.2) |
| Related to chemotherapy | 11 (4.4) | 7 (2.8) | NA | NA | NA | NA |
| TEAE leading to discontinuation | 6 (2.4) | 3 (1.2) | 11 (4.6) | 9 (3.7) | 16 (6.4) | 12 (4.8) |
| TEAE of special interest | 204 (81.6) | 197 (78.2) | 117 (49.2) | 110 (45.5) | 220 (88.0) | 213 (84.5) |
| Cardiotoxic effects | 65 (26.0) | 60 (23.8) | 53 (22.3) | 50 (20.7) | 92 (36.8) | 87 (34.5) |
| Infusion site reactions and hypersensitivity | 118 (47.2) | 116 (46.0) | 35 (14.7) | 27 (11.2) | 127 (50.8) | 121 (48.0) |
| Hematotoxic effects | 134 (53.6) | 124 (49.2) | 51 (21.4) | 47 (19.4) | 144 (57.6) | 142 (56.3) |
| Pulmonary disorders | 16 (6.4) | 14 (5.6) | 15 (6.3) | 12 (5.0) | 29 (11.6) | 23 (9.1) |
| Infections | 47 (18.8) | 47 (18.7) | 22 (9.2) | 27 (11.2) | 61 (24.4) | 64 (25.4) |
| TEAEs by PT reported ≥10% | ||||||
| Alopecia | 202 (80.8) | 200 (79.4) | NA | NA | 202 (80.8) | 200 (79.4) |
| Asthenia | 65 (26.0) | 59 (23.4) | 15 (6.3) | 17 (7.0) | 68 (27.2) | 66 (26.2) |
| Fatigue | 59 (23.6) | 60 (23.8) | 11 (4.6) | 10 (4.1) | 62 (24.8) | 67 (26.6) |
| Nausea | 86 (34.4) | 93 (36.9) | 2 (0.8) | 1 (0.4) | 86 (34.4) | 93 (36.9) |
| Diarrhea | 45 (18.0) | 42 (16.7) | 5 (2.1) | 4 (1.7) | 47 (18.8) | 45 (17.9) |
| Neutropenia | 69 (27.6) | 72 (28.6) | 15 (6.3) | 14 (5.8) | 77 (30.8) | 78 (31.0) |
| Anemia | 68 (27.2) | 56 (22.2) | 19 (8.0) | 14 (5.8) | 72 (28.8) | 61 (24.2) |
| Leukopenia | 36 (14.4) | 38 (15.1) | 19 (8.0) | 21 (8.7) | 44 (17.6) | 51 (20.2) |
| Aminotransferase levels increased | ||||||
| Alanine | 28 (11.2) | 34 (13.5) | 12 (5.0) | 13 (5.4) | 35 (14.0) | 41 (16.3) |
| Aspartate | 25 (10.0) | 24 (9.5) | 19 (8.0) | 16 (6.6) | 37 (14.8) | 31 (12.3) |
| Arthralgia | 28 (11.2) | 23 (9.1) | 14 (5.9) | 11 (4.5) | 40 (16.0) | 31 (12.3) |
| Procedural pain | 31 (12.4) | 29 (11.5) | 5 (2.1) | 16 (6.6) | 36 (14.4) | 44 (17.5) |
Abbreviations: aSAF, adjuvant safety set; NA, not applicable; PT, preferred term; SAF, safety set; TEAE, treatment-emergent adverse event.
a
Percentage calculated based on number for each treatment group.