Adverse reaction profile for Portrazza1
Adverse reactions occurring at incidence rate ≥5% all grades or a ≥2% grade 3/4 difference between arms in patients receiving Portrazza in the SQUIRE trial
MedDRA=Medical Dictionary for Regulatory Activities.
*Pulmonary embolism is also included in the composite term venous thromboembolic events under system organ class vascular disorders.
†VTE is a composite term that includes pulmonary embolism, deep vein thrombosis, thrombosis, mesenteric vein thrombosis, pulmonary artery thrombosis, pulmonary venous thrombosis, venous thrombosis limb, axillary vein thrombosis, thrombophlebitis, thrombosis in device, vena cava thrombosis, venous thrombosis, subclavian vein thrombosis, superior vena cava syndrome, and thrombophlebitis superficial.
‡Conjunctivitis is a composite term that includes conjunctivitis, eye irritation, vision blurred, conjunctivitis bacterial, dry eye, visual acuity reduced, blepharitis, allergic blepharitis, conjunctiva hemorrhage, eye infection, eye pain, lacrimation increased, ocular hyperemia, Sjögren’s syndrome, visual impairment, and eye pruritus.
Reference: 1. Portrazza (necitumumab) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2015.
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