Table 3:
Adverse Event | TREATMENT ARM BY GRADE, n(%) | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abraxane 35 mg/m2 (n=4) | Abraxane 70 mg/m2 (n=4) | Abraxane 90 mg/m2 (n=3) | Abraxane 112.5 mg/m2 (n=6) | Abraxane 140 mg/m2 (n=7) | Abraxane 175 mg/m2 (n=3) | |||||||||||||
2 | 3 | 4 | 2 | 3 | 4 | 2 | 3 | 4 | 2 | 3 | 4 | 2 | 3 | 4 | 2 | 3 | 4 | |
AST, SGOT | 0 | 0 | 0 | 0 | 0 | 0 | 2(67%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Albumin, serum-low | 0 | 0 | 0 | 1(25%) | 0 | 0 | 0 | 0 | 0 | 1(17%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Alkaline phosphatase | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1(33%) | 0 | 1(17%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Amylase | 0 | 0 | 0 | 0 | 0 | 1(25%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Anorexia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1(17%) | 0 | 1(14%) | 0 | 0 | 0 | 0 | 0 |
Diarrhea | 0 | 0 | 0 | 1(25%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1(14%) | 0 | 0 | 0 | 0 | 0 |
Distension/bloating, abdominal | 0 | 0 | 0 | 1(25%) | 0 | 0 | 0 | 0 | 0 | 2(33%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Fatigue | 0 | 0 | 0 | 2(50%) | 0 | 0 | 1(33%) | 0 | 0 | 1(17%) | 1(17%) | 0 | 3(43%) | 2(29%) | 0 | 1(33%) | 1(33%) | 0 |
Glucose, serum-high | 0 | 0 | 0 | 1(25%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Hair loss/alopecia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1(17%) | 0 | 0 | 1(14%) | 0 | 0 | 0 | 0 | 0 |
Hemoglobin | 1(25%) | 0 | 0 | 2(50%) | 0 | 0 | 2(67%) | 0 | 0 | 1(17%) | 1(17%) | 0 | 1(14%) | 2(29%) | 0 | 2(67%) | 0 | 0 |
Infection | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1(33%) | 0 |
Left ventricular systolic dysfunction | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1(33%) | 0 | 0 |
Leukocytes | 0 | 0 | 0 | 1(25%) | 1(25%) | 0 | 0 | 0 | 0 | 2(33%) | 1(17%) | 1(17%) | 3(43%) | 1(14%) | 0 | 1(33%) | 1(33%) | 0 |
Lipase | 0 | 0 | 0 | 0 | 0 | 1(25%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Lymphopenia | 0 | 0 | 0 | 0 | 0 | 2(50%) | 1(33%) | 0 | 0 | 0 | 2(33%) | 0 | 0 | 2(29%) | 0 | 0 | 0 | 0 |
Mucositis/stomatitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1(33%) | 0 | 0 |
Neuropathy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1(14%) | 0 | 0 | 0 | 0 | 0 |
Neutrophils/granulocytes | 0 | 0 | 0 | 1(25%) | 1(25%) | 0 | 0 | 0 | 0 | 2(33%) | 1(17%) | 1(17%) | 0 | 2(29%) | 0 | 1(33%) | 0 | 2(67%) |
Pain | 2(50%) | 0 | 0 | 1(25%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1(14%) | 0 | 0 | 1(33%) | 1(33%) | 0 |
Pancreatitis | 0 | 0 | 0 | 0 | 1(25%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Phosphate, serum-low | 0 | 0 | 0 | 1(25%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Platelets | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1(17%) | 0 | 0 | 0 | 0 | 0 | 0 |
Proteinuria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1(14%) | 0 | 0 | 0 | 0 | 0 |
Rash/desquamation | 0 | 0 | 0 | 0 | 1(25%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Sodium, serum-low | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1(17%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Ulcer, GI | 0 | 0 | 0 | 0 | 0 | 0 | 1(33%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Vomiting | 1(25%) | 0 | 0 | 2(50%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |