Table 1.

Study Characteristics

Candidate Study Profile				Source of Known Safety Profile
Study	Patient Population	Study Treatment	Safety Analysis Population	Precursor Studies	Primary Precursor Study Population	Precursor Study Treatment	Safety Analysis Population
AVAiL8	First-line nonsquamous NSCLC	Arm 1: cisplatin/gemcitabine Arm 2: cisplatin/gemcitabine + bevacizumab	656	AVF2107g9	First-line mCRC	Arm 1: irinotecan/FU/LV (bolus-IFL) + placebo Arm 2: bolus IFL + bevacizumab	813
				ECOG 320016	Second-line mCRC	FOLFOX4; FOLFOX4 + bevacizumab	585
AVF2107g9*	First-line mCRC	Arm 1: irinotecan/FU/LV (bolus IFL) + placebo Arm 2: bolus IFL + bevacizumab	788	AVF2119g17	mBC	Arm 1: capecitabine Arm 2: capecitabine + bevacizumab	462
ECOG 459910	First-line nonsquamous NSCLC	Arm 1: paclitaxel/carboplatin Arm 2: paclitaxel/carboplatin + bevacizumab	878	AVF2107g4	First-line mCRC	Arm 1: irinotecan/FU/LV (bolus IFL) + placebo Arm 2: bolus IFL + bevacizumab	813
				ECOG 320016	Second-line mCRC	FOLFOX4; FOLFOX4 + bevacizumab	585
EGF3000111	First-line mBC	Arm 1: paclitaxel + placebo Arm 2: paclitaxel + lapatinib	580	EGF10015118	Refractory advanced or mBC	Arm 1: capecitabine Arm 2: capecitabine + lapatinib	408
JMDB12	First-line NSCLC	Arm 1: cisplatin plus pemetrexed Arm 2: cisplatin plus gemcitabine	1,669	JMCH19	MPM	Arm 1: cisplatin plus pemetrexed Arm 2: cisplatin	331
IBCSG BIG 1-9813	PMP women with HR+ EBC	Arm 1: letrozole Arm 2: tamoxifen; double-blind using double-dummy technique	7,963	NCIC MA-17 (PI 11/2004)20	Extended Adjuvant	Letrozole 2.5 mg orally daily for 5 years Placebo orally daily for 5 years; double-blind using double-dummy technique	5,136
CALGB 8980314	Patients with resected adenocarcinoma of the colon	Arm 1: LV + FU Arm 2: irinotecan + LV + FU	1,264	Cunningham et al,21 1998	mCRC	Irinotecan v best supportive care (FU failures)	279
				Rougier et al,22 1998	mCRC	Irinotecan v FU	267
HERA15	HER2+ adj breast cancer	Arm 1: observation Arm 2: trastuzumab	3,386	H0648g23	First-line mBC	Trastuzumab + CT v CT alone; CT was either (1) anthracycline + cyclophosphamide or (2) paclitaxel + cyclophosphamide	469

Abbreviations: AVAiL, Avastin in Lung; NSCLC, non–small-cell lung cancer; ECOG, Eastern Cooperative Oncology Group; mCRC, metastatic colorectal cancer; FU, fluorouracil; LV, leucovorin; IFL, irinotecan plus fluorouracil and leucovorin; FOLFOX4, infusional fluorouracil, leucovorin, and oxaliplatin; mBC, metastatic breast cancer; MPM, malignant pleural mesothelioma; IBCSG, International Breast Cancer Study Group; BIG, Breast International Group; PMP, postmenopausal; HR, hormone receptor; EBC, early breast cancer; NCIC, National Cancer Institute of Canada; PI, package insert (US); CALGB, Cancer and Leukemia Group B; HERA, HERceptin Adjuvant; adj, adjuvant; CT, chemotherapy.

^*AVF2107g was a three-arm trial. A third arm with treatment of FU/LVplus recombinant humanized monoclonal antibody vascular endothelial growth factor was omitted from this analysis.