|
Any AE
|
308 (95.1)
|
289 (93.5)
|
|
Any grade ≥ 3 AE
|
139 (42.9)
|
137 (44.3)
|
|
Any fatal AE
|
13 (4.0)
|
11 (3.6)
|
|
Any serious AE
|
85 (26.2)
|
71 (23.0)
|
|
Any AE leading to discontinuation of IP
|
61 (18.8)
|
53 (17.2)
|
|
Any AE leading to discontinuation of any component of chemotherapy
|
74 (22.8)
|
59 (19.1)
|
|
Any AE leading to dose delay of IP
|
73 (22.5)
|
69 (22.3)
|
|
Any AE leading to dose delay of any component of chemotherapy
|
86 (26.5)
|
83 (26.9)
|
|
Any AE leading to dose reduction of any component of chemotherapy
|
48 (14.8)
|
49 (15.9)
|
|
Grade ≥ 3 EOIs
|
102 (31.5)
|
99 (32)
|
|
Grade ≥ 3 anti-VEGF-associated toxicities, n (%)
|
|
Hypertension
|
22 (6.8)
|
17 (5.5)
|
|
GI perforation
|
3 (0.9)
|
4 (1.3)
|
|
Pulmonary hemorrhage
|
2 (0.6)
|
5 (1.6)
|
|
Wound healing complications
|
1 (0.3)
|
2 (0.6)
|
|
Proteinuria
|
1 (0.3)
|
1 (0.3)
|