Table 4. Grade 3/4 bevacizumab-related serious adverse events in NO16966 and First BEAT and surgical complications in resected patients in First BEAT.
| Bleeding | Wound healing complications | GI perforation | Hypertension | Arterial thrombo-embolism | |
|---|---|---|---|---|---|
| NO16966 | |||||
| FOLFOX4 or XELOX + placebo (n=675) | 8 (1.2%) | 2 (0.3%) | 2 (0.3%) | 8 (1.2%) | 7 (1.0%) |
| FOLFOX4 or XELOX + bevacizumab (n=694) | 13 (1.9%) | 1 (0.1%) | 4 (0.6%) | 26 (3.7%) | 12 (1.7%) |
| First BEAT (ITT population n=1914) | 61 (3.2%) | 20 (1.0%) | 34 (1.8%) | 97 (5.1%) | 24 (1.3%) |
| First BEAT | |||||
| Surgical complications in patients undergoing curative-intent metastasectomy (n=225) | 1 (0.4%) Any grade: 3 (1.3%) | 4 (1.8%) Any grade: 11 (4.9%) | 5 (2.2%) | 16 (7.1%) | 3 (1.3%) |
Abbreviations: BEAT=bevacizumab expanded access trial; FOLFOX4=5-FU and oxaliplatin; ITT=intention to treat; XELOX=capecitabine plus oxaliplatin.