Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study)

Table 3

Incidences of SAEs during the 18-month follow-up period (safety set).

Preferred term, (%)	Unilateral DME ()	Bilateral DME ()
Any SAE	7 (4.46)	22 (4.84)
Cardiac disorders	2 (1.27)	6 (1.32)
Acute myocardial infarction	0	1 (0.22)
Atrial flutter	1 (0.64)	0
Cardiac arrest	0	1 (0.22)
Cardiac failure	0	3 (0.66)
Cardiopulmonary failure	0	1 (0.22)
Congestive cardiomyopathy	1 (0.64)	0
Ischemic cardiomyopathy	0	1 (0.22)
Myocardial ischemia	1 (0.64)	0
Eye disorders	0	2 (0.44)
General disorders and administration site conditions	0	1 (0.22)
Infections and infestations	0	3 (0.66)
Injury, poisoning, and procedural complications	0	2 (0.44)
Metabolism and nutrition disorders	0	1 (0.22)
Musculoskeletal and connective tissue disorders	0	1 (0.22)
Neoplasms benign, malignant, and unspecified (including cysts and polyps)	1 (0.64)	3 (0.66)
Nervous system disorders	2 (1.27)	3 (0.66)
Renal and urinary disorders	1 (0.64)	1 (0.22)
Respiratory, thoracic, and mediastinal disorders	1 (0.64)	1 (0.22)
Surgical and medical procedures	0	1 (0.22)
Vascular disorders	1 (0.64)	1 (0.22)

DME, diabetic macular edema; SAE, serious adverse event.