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Table 1 Safety findings in the comparative clinical trial of ABP 215 and bevacizumab (MAPLE) [17]

From: The Totality of Evidence and Use of ABP 215, a Biosimilar to Bevacizumab

AE, n (%) ABP 215 (n = 324) Bevacizumab (n = 309)
Any AE 308 (95.1) 289 (93.5)
Any grade ≥ 3 AE 139 (42.9) 137 (44.3)
Any fatal AE 13 (4.0) 11 (3.6)
Any serious AE 85 (26.2) 71 (23.0)
Any AE leading to discontinuation of IP 61 (18.8) 53 (17.2)
Any AE leading to discontinuation of any component of chemotherapy 74 (22.8) 59 (19.1)
Any AE leading to dose delay of IP 73 (22.5) 69 (22.3)
Any AE leading to dose delay of any component of chemotherapy 86 (26.5) 83 (26.9)
Any AE leading to dose reduction of any component of chemotherapy 48 (14.8) 49 (15.9)
Grade ≥ 3 EOIs 102 (31.5) 99 (32)
Grade ≥ 3 anti-VEGF-associated toxicities, n (%)
 Hypertension 22 (6.8) 17 (5.5)
 GI perforation 3 (0.9) 4 (1.3)
 Pulmonary hemorrhage 2 (0.6) 5 (1.6)
 Wound healing complications 1 (0.3) 2 (0.6)
 Proteinuria 1 (0.3) 1 (0.3)
  1. AE adverse event, EOI event of interest, GI gastrointestinal, IP investigational product, VEGF vascular endothelial growth factor