Table 2

Bevacizumab safety analysis in Eastern Cooperative Oncology Group (ECOG) studies.

Hemorrhage and thrombosis/embolism were reported by an expedited adverse event reporting system. The denominator for these toxicities were based on the total number of patients accrued per arm because all grade 3–4 toxicities were reported by this mechanism. The denominator for hypertension indicates the number of case report forms available for review.

Study/Treatment armsHemorrhageThrombosis/EmbolismHypertension
Grade 3Grade 4Grade 3Grade 4Grade 3Grade 4
E3200 (colon)
 FOLFOXa+ bevacizumab3/160 (1.9%)1/160 (0.6%)1/160 (1.9%)0/1606/75 (8.0%)1/75 (1.3%)
 FOLFOX1/160 (0.6%)0/1602/160 (1.3%)1/160 (0.6%)1/73 (1.4%)0/73
 Bevacizumab3/160 (1.9%)2/160 (1.3%)1/160 (1.3%)1/160 (0.6%)5/75 (6.7%)0/75
E4599 (lung)
 CP + bevacizumab1/60 (1.7%)0/600/601/60 (1.7%)3/54 (5.6%)0/54
 CP2/60 (3.3%)0/600/601/60 (1.7%)0/520/52
E2100 (breast)
 P + bevacizumab0/500/501/50 (2.0%)0/500/101/10 (10%)
 P0/500/502/50 (4.0%)0/500/60/6
E2200 (colon)
 IFL + bevacizumab0/891/89 (1.1%)4/89 (4.5%)4/89 (4.5%)1/85 (1.2%)0/85
Total, all studies bevacizumab-containing arms7/619 (1.1%)4/619 (0.6%)7/619 (1.1%)6/619 (0.9%)15/299 (5.0%)2/299 (0.7%)
  • a FOLFOX, 5-fluorouracil, leucovorin, oxaliplatin; CP, carboplatin/paclitaxel; P, weekly paclitaxel; IFL, irinotecan; 5-fluorouracil, leucovorin.