Table 3 Pooled safety results of bevacizumab trials for first-line treatment of advanced breast cancer (E2100, AVADO, RIBBON-1 y
From: Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study
Severe or life-threatening or fatal adverse events | Pooled chemotherapy (n = 982) | Pooled bevacizumab plus chemotherapy (n = 1679 |
|---|---|---|
% | % | |
Any | 23 | 37 |
Sensory neuropathy | 7.1 | 10 |
Hypertension | 1.2 | 9 |
Febrile neutropenia | 3.5 | 6.5 |
Venous thromboembolic event | 3.8 | 2.8 |
Proteinuria | 0 | 2.3 |
Arterial thromboembolic event | 0.3 | 1.6 |
Left ventricular systolic dysfunction | 1.2 | 1.5 |
Hemorrhage | 0.4 | 1.5 |
Abnormal tissue repair | 0.8 | 1.7 |
Wound dehiscence | 0.3 | 0.8 |
Fistula | 0.3 | 0.5 |
Gastrointestinal perforation | Â | 0.5 |
Reversible posterior leukoencephalopathy syndrome | 0 | <0.1 |