Table 2.
Grade ≥ 3 adverse events occurring in randomized phase III trials of bevacizumab in advanced ovarian cancer
| Grade ≥ 3 AE, % |
GOG-0218
[21] |
ICON7
[22] |
OCEANS
[41] |
AURELIA
[26] |
|||||
|---|---|---|---|---|---|---|---|---|---|
|
CP + placebo |
CP + Bev |
CP + Bev → Bev |
CP |
CP + Bev → Bev |
CG + placebo |
CG + Bev |
CTx |
CTx + Bev |
|
| ( n = 601) | ( n = 607) | ( n = 608) | ( n = 753) | ( n = 745) | ( n = 233) | ( n = 247) | ( n = 182) | ( n = 179) | |
|
Neutropenia |
57.7a |
63.3a |
63.3a |
15 |
17 |
– |
– |
– |
– |
|
Pain |
41.6b |
41.5b |
47.0b |
– |
– |
– |
– |
– |
– |
|
Thrombocytopenia |
– |
– |
– |
2 |
3 |
34 |
40 |
– |
– |
|
Hypertension |
7.2b |
16.5b |
22.9b |
<1 |
6 |
0.4 |
17.8 |
– |
– |
|
VTE |
5.8c |
5.3c |
6.7c |
2 |
4 |
– |
– |
4 |
3 |
|
Febrile neutropenia |
3.5c |
4.9c |
4.3c |
2 |
3 |
– |
– |
1 |
1 |
|
Proteinuria |
0.7 |
0.7 |
1.6 |
<1 |
1 |
0.9 |
9.7 |
– |
– |
|
Bleeding (non-CNS) |
0.8 |
1.3 |
2.1 |
<1 |
1 |
0.9 |
5.7 |
1 |
1 |
|
Wound healing complications |
2.8c |
3.6c |
3.0c |
<1 |
1 |
– |
– |
– |
– |
|
ATE |
0.8c |
0.7c |
0.7c |
1 |
3 |
– |
– |
0 |
2 |
|
GI events |
1.2b |
2.8b |
2.6b |
<1 |
1 |
0 |
0 |
– |
– |
|
Epistaxis |
– |
– |
– |
– |
– |
0.4 |
4.9 |
– |
– |
|
Abscess/fistula |
– |
– |
– |
1 |
1 |
0.4c |
1.6c |
– |
– |
|
RPLS |
0 |
0.2c |
0.2c |
0 |
0 |
0 |
0.8c |
0 |
1 |
|
CHF |
– |
– |
– |
<1 |
<1 |
– |
– |
1 |
1 |
| CNS bleeding | 0 | 0 | 0.3c | 0 | <1 | – | – | – | – |
AE = adverse event. ATE = arterial thromboembolic event. Bev = bevacizumab. C = carboplatin. CHF = congestive heart failure. CNS = central nervous system. CTx = chemotherapy. G = gemcitabine. GI = gastrointestinal. P = paclitaxel. RPLS = reverse posterior leukoencephalopathy syndrome. VTE = venous thromboembolic event.
aGrade ≥ 4.
bGrade ≥ 2.
cAll grades.