Table 2.
Safety summary during the overall treatment period in the safety-evaluable population
| Number of patients, n (%) | Pertuzumab group (n = 218) | Placebo group (n = 110) |
|---|---|---|
| Any-grade AEs | 218 (100) | 109 (99.1) |
| Ten most common AEs | ||
| Neutropenia | 154 (70.6) | 73 (66.4) |
| Leukopenia | 135 (61.9) | 67 (60.9) |
| Alopecia | 115 (52.8) | 56 (50.9) |
| Nausea | 84 (38.5) | 40 (36.4) |
| Anemia | 75 (34.4) | 37 (33.6) |
| Diarrhea | 89 (40.8) | 19 (17.3) |
| Alanine aminotransferase increased | 64 (29.4) | 41 (37.3) |
| Aspartate aminotransferase increased | 54 (24.8) | 34 (30.9) |
| Upper respiratory tract infections | 58 (26.6) | 14 (12.7) |
| Decreased appetite | 40 (18.3) | 13 (11.8) |
| Grade ≥3 AEs | 154 (70.6) | 75 (68.2) |
| During FEC phase | 100 (48.1) | 45 (43.7) |
| During adjuvant anti-HER2 phase | 23 (11.3) | 13 (13.1) |
| Neutropenia | 129 (59.2) | 61 (55.5) |
| Leukopenia | 75 (34.4) | 38 (34.5) |
| Febrile neutropenia | 11 (5.0) | 4 (3.6) |
| Anemia | 9 (4.1) | 5 (4.5) |
| Thrombocytopenia | 7 (3.2) | 1 (0.9) |
| Menstruation irregular | 8 (3.7) | 0 |
| Serious AEs | 37 (17.0) | 15 (13.6) |
| Febrile neutropenia | 9 (4.1) | 3 (2.7) |
| Pneumonia | 4 (1.8) | 1 (0.9) |
| Myelosuppression | 3 (1.4) | 0 |
| Grade 5 AEsa | 2 (0.9) | 2 (1.8) |
| AEs leading to treatment withdrawal | 2 (0.9) | 0 |
| AEs leading to treatment modification | 41 (18.8) | 17 (15.5) |
| AEs of special interest | 0 | 0 |
| Primary cardiac events (heart failure [NYHA functional classification III or IV] and significant LVEF declineb) | 0 | 0 |
| Significant LVEF decline eventsb | 2 (0.9) | 2 (1.8) |
| Secondary cardiac events | 0 | 0 |
AE adverse event, FEC 5-fluorouracil, epirubicin, and cyclophosphamide, HER2 human epidermal growth factor receptor 2, LVEF left ventricular ejection fraction, NYHA New York Heart Association.
aDeaths due to an AE occurred in two patients (suicide in the neoadjuvant period and pneumonia in the treatment-free follow-up period) in the pertuzumab arm and two patients (sudden death in the treatment-free follow-up period) in the placebo arm.
bA significant LVEF decline is defined as an absolute decrease of at least 10 points below the baseline measurement and to an LVEF of <50%.