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. 2019 Mar 8;37(3):538–547. doi: 10.1007/s10637-019-00755-x

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