Table 2.

Grade 3–4 SAEs in bevacizumab phase 3 trials in FDA-approved indications and median PFS and OS

Cancer type	Grade 3–4 SAEs occurring 2% of chemotherapy-alone arms; % absolute increase over control arm
	Bleeding	Hypertension	Venous thromboembolism	Proteinuria	Significant improvement median PFS?	Significant improvement median OS?
NSCLC [49]	3.7%	6.3%	2%	3%	Yes (6.2 vs 4.5 mo)	Yes (12.3 vs 10.3 mo)
mCRC [50]	—	10%	4%	—	Yes (8.8 vs 6.8 mo)	Yes (20.3 vs 15.6 mo)
MBC [43]	0.5%	14.8%	1.5%	3%	Yes	No
GBM [51]	1.2%	4.9%	6%	—	No	No
mRCC [52] Avastin package insert	3%	3%	2%	7%	Yes (10.2 vs 5.4 mo)	No

GBM, glioblastoma multiforme; MBC, metastatic breast cancer; mCRC, metastatic colorectal cancer; mRCC, metastatic renal cell cancer; NSCLC, non–small cell lung cancer; OS, overall survival; PFS, progression-free survival; SAE, severe adverse event.