Adverse Event
NPLS (175 mg/m
2
) N=48 N (%)
NPLS (80 mg/m
2
) N=45 N (%)
Taxol
®
(175 mg/m
2
) N=27 N (%)
Hematologic
Neutropenia
15 (31.25)
20 (44.44)
2 (7.41)
Anemia
8 (16.67)
20 (44.44)
5 (18.52)
Leukopenia
6 (12.50)
2 (4.44)
4 (14.81)
Thrombocytopenia
5 (10.42)
1 (2.22)
0
Nonhematologic
Alopecia
14 (29.17)
15 (33.33)
9 (33.33)
Cough
2 (4.17)
10 (22.22)
2 (7.41)
Diarrhoea
1 (2.08)
4 (8.88)
1 (3.70)
Nausea
2 (4.16)
3 (6.66)
1 (3.70)
Vomiting
3 (6.25)
5 (11.11)
0
UTI
12 (25)
8 (17.78)
3 (11.11)
Peripheral Neuropathy
0
3 (6.66)
0
Pyrexia
7 (14.58)
6 (13.33)
2 (7.41)
Chills
25 (52.08)
18 (40.00)
2 (7.41)
Table 2:
Adverse Events Occurring After First Study Treatment of Nanosomal Paclitaxel Lipid Suspension (NPLS) or Taxol
®
. (ITT, n=120).