Table 4.
Treatment-emergent adverse events by CTCAE grade in the safety population*
| TEAEs | Severity, N (%) | ||||
|---|---|---|---|---|---|
| All grades | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Hematologic toxicities (n = 25) | |||||
| White blood cell count decreased | 10(40.0) | 3(12.0) | 4(16.0) | 3(12.0) | 0(0) |
| Neutrophil count decreased | 8(32.0) | 1(4.0) | 0(0) | 3(12.0) | 4(16.0) |
| Anemia | 11(44.0) | 7(28.0) | 1(4.0) | 3(12.0) | 0(0) |
| Aspartate aminotransferase increased | 6(24.0) | 4(16.0) | 2(8.0) | 0(0) | 0(0) |
| Alanine aminotransferase increased | 7(28.0) | 4(16.0) | 3(120) | 0(0) | 0(0) |
| Blood bilirubin increased | 3(12.0) | 1(4.0) | 2(8.0) | 0(0) | 0(0) |
| Creatinine increased | 5(20.0) | 4(16.0) | 1(4.0) | 0(0) | 0(0) |
| Platelet count decreased | 0(0) | 0(0) | 0(0) | 0(0) | 0(0) |
| Nonhematologic toxicities (n = 25) | |||||
| Alopecia | 23(92.0) | 13(52.0) | 10(40.0) | – | – |
| Fatigue | 17(68.0) | 8(32.0) | 7(28.0) | 2(8.0) | 0(0) |
| Sensory peripheral neuropathy | 15(60.0) | 12(48.0) | 2(8.0) | 1(4.0) | 0(0) |
| Anorexia | 12(48.0) | 7(28.0) | 4(16.0) | 1(4.0) | 0(0) |
| Mucositis oral | 9(36.0) | 9(36.0) | 0(0) | 0(0) | 0(0) |
| Motor peripheral neuropathy | 8(32.0) | 4(16.0) | 4(16.0) | 0(0) | 0(0) |
| Diarrhea | 7(28.0) | 5(20.0) | 2(8.0) | 0(0) | 0(0) |
| Arthralgia | 6(24.0) | 4(16.0) | 2(8.0) | 0(0) | 0(0) |
| Myalgia | 5(20.0) | 4(16.0) | 0(0) | 1(4.0) | 0(0) |
| Nausea | 5(20.0) | 5(20.0) | 0(0) | 0(0) | 0(0) |
| Nail discoloration | 4(16.0) | 4(16.0) | – | – | – |
| Dysgeusia | 4(16.0) | 2(8.0) | 2(8.0) | – | – |
| Rash | 3(12.0) | 3(12.0) | 0(0) | 0(0) | 0(0) |
| Vomiting | 3(12.0) | 3(12.0) | 0(0) | 0(0) | 0(0) |
| Edema limbs | 3(12.0) | 3(12.0) | 0(0) | 0(0) | 0(0) |
| Lung infection | 1(4.0) | 0(0) | 0(0) | 1(4.0) | 0(0) |
| Infusion-related reaction by pertuzumab | 1(4.0) | 0(0) | 0(0) | 1(4.0) | 0(0) |
| Constipation | 1(4.0) | 1(4.0) | 0(0) | 0(0) | 0(0) |
| Epistaxis | 1(4.0) | 1(4.0) | 0(0) | 0(0) | 0(0) |
| Olfactory nerve disorder | 1(4.0) | 1(4.0) | 0(0) | 0(0) | 0(0) |
| Nail loss | 1(4.0) | 1(4.0) | 0(0) | – | – |
*The safety population consisted of patients who received at least one dose of the study drugs
CTCAE common terminology criteria for adverse events