Table 2 Adverse events Grade 3 and above, experienced by ≥5% of participants following TDM1, THP, TH, or AC.
T-DM1+P arm | THP arm | TH control arm | ||||
|---|---|---|---|---|---|---|
T-DM1/P (n = 52) | AC (n = 49) | THP (n = 45) | AC (n = 40) | Paclitaxel (n = 31) | AC (n = 28) | |
Adverse event, n (%) | ||||||
Anemia | 2 (3.9%) | 2 (4.1%) | 1 (2.2%) | 4 (10.0%) | 1 (3.2%) | 0 (0.0%) |
Diarrhea | 0 (0.0%) | 6 (12.2%) | 0 (0.0%) | 0 (0.0%) | 1 (3.2%) | 0 (0.0%) |
Febrile neutropenia | 0 (0.0%) | 8 (16.3%) | 0 (0.0%) | 5 (12.5%) | 0 (0.0%) | 3 (10.7%) |
Hypertension | 2 (3.8%) | 0 (0.0%) | 2 (4.4%) | 0 (0.0%) | 3 (9.7%) | 3 (10.7%) |
Neutrophil count decreased | 0 (0.0%) | 6 (12.2%) | 2 (4.4%) | 1 (2.5%) | 1 (3.2%) | 2 (7.1%) |
Vascular access complication | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (7.1%) |
White blood cell count decreased | 0 (0.0%) | 2 (4.1%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (7.1%) |
Dose Reductions, n (%) | 1 (1.9%) | 3 (5.8%) | 3 (6.7%) | 5 (20%) | 0 (0.0%) | 0 (0.0%) |
Early Discontinuation, n (%) | ||||||
All | 3 (5.8%) | 5 (10.2%) | 5 (11%) | 4 (10%) | 3 (9.7%) | 3 (10.7%) |
Toxicity | 1 (1.9%) | 3 (6.1%) | 3 (6.7%) | 2 (5.0%) | 0 (0.0%) | 0 (0.0%) |
Progression | 1 (1.9%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
Other | 1 (1.9%) | 2 (4.1%) | 2 (4.4% | 2 (5.0%) | 3 (9.7%) | 3 (10.7%) |
Median time to surgery*, days (range) | 170 (148–239) | 176 (112–219) | 171 (119–239) | |||
