|
nab-PTX plus RAM
|
PTX plus RAM
|
P value
|
---|
(N = 113)
|
(N = 138)
|
---|
|
Any grade (%)
|
>Grade 3 (%)
|
Any grade (%)
|
>Grade 3 (%)
|
Any grade
|
>Grade 3
|
All adverse events
|
112 (99.1)
|
76 (67.3)
|
134 (97.1)
|
88 (63.8)
|
0.254
|
0.563
|
Hematological
|
Neutropenia
|
91 (80.5)
|
64 (56.6)
|
108 (78.3)
|
76 (55.1)
|
0.659
|
0.804
|
Leukopenia
|
85 (75.2)
|
34 (30.1)
|
107 (77.5)
|
48 (34.8)
|
0.667
|
0.43
|
Anemia
|
105 (92.9)
|
8 (7.1)
|
112 (81.2)
|
19 (13.8)
|
0.007
|
0.089
|
Thrombocytopenia
|
43 (38.1)
|
6 (5.3)
|
35 (25.4)
|
4 (2.9)
|
0.031
|
0.258
|
Non-hematological
|
Sensory neuropathy
|
72 (63.7)
|
2 (1.8)
|
51 (37.0)
|
0 (0.0)
|
0
|
0.202
|
Fatigue
|
42 (37.2)
|
1 (0.9)
|
33 (23.9)
|
0 (0.0)
|
0.022
|
0.45
|
Anorexia
|
33 (29.2)
|
1 (0.9)
|
29 (21.0)
|
1 (0.7)
|
0.134
|
0.699
|
Nausea
|
17 (15.0)
|
2 (1.8)
|
18 (13.0)
|
1 (0.7)
|
0.649
|
0.425
|
Diarrhea
|
7 (6.2)
|
0 (0.0)
|
14 (10.1)
|
0 (0.0)
|
0.261
|
–
|
Stomatitis
|
10 (8.8)
|
0 (0.0)
|
14 (10.1)
|
1 (0.7)
|
0.728
|
0.55
|
Edema
|
33 (29.2)
|
0 (0.0)
|
32 (23.2)
|
0 (0.0)
|
0.279
|
–
|
Proteinuria
|
30 (26.5)
|
3 (2.7)
|
29 (21.0)
|
2 (1.4)
|
0.304
|
0.406
|
Hypertension
|
30 (26.5)
|
15 (13.3)
|
27 (19.6)
|
9 (6.5)
|
0.189
|
0.07
|
Febrile neutropenia
|
6 (5.1)
|
6 (5.1)
|
13 (9.4)
|
13 (9.4)
|
0.221
|
0.221
|
Interstitial pneumonia
|
8 (7.1)
|
3 (2.7)
|
5 (3.6)
|
3 (2.2)
|
0.219
|
0.56
|
Hypersensitivity reaction
|
0 (0.0)
|
0 (0.0)
|
2 (1.4)
|
2 (1.4)
|
–
|
–
|
- nab-PTX nanoparticle albumin-bound paclitaxel, RAM ramucirumab