Table 3 Overall safety summary
TEAE, n (%) | Safety analysis set | |
|---|---|---|
T-DXd n = 371 | TPC n = 172 | |
Any-grade TEAEs | 369 (99.5) | 169 (98.3) |
Drug-related | 357 (96.2) | 162 (94.2) |
Grade ≥3 TEAEs | 202 (54.4) | 116 (67.4) |
Drug-related | 159 (42.9) | 99 (57.6) |
Serious TEAEs | 108 (29.1) | 44 (25.6) |
Drug-related | 49 (13.2) | 20 (11.6) |
TEAEs associated with dose discontinuation | 62 (16.7) | 14 (8.1) |
Drug-related | 57 (15.4) | 12 (7.0) |
TEAEs associated with dose interruption | 155 (41.8) | 73 (42.4) |
Drug-related | 113 (30.5) | 62 (36.0) |
TEAEs associated with dose reduction | 89 (24.0) | 65 (37.8) |
Drug-related | 83 (22.4) | 63 (36.6) |
TEAEs associated with death | 15 (4.0) | 5 (2.9) |
Drug-related | 7 (1.9) | 0 |
Total on-treatment deathsa | 14 (3.8) | 8 (4.7) |
