Clinical Study
Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study)
Table 4
Incidences of AEs during the 18-month follow-up period (safety set).
| | Preferred term, (%) | Unilateral DME () | Bilateral DME () |
| | Any AE | 12 (7.64) | 49 (10.77) | | Blood and lymphatic system disorders | 0 | 1 (0.22) | | Cardiac disorders | 2 (1.27) | 6 (1.32) | | Eye disorders (mainly cataract, conjunctival hemorrhage, and diabetic retinal edema being the major) | 5 (3.18) | 19 (4.18) | | General disorders and administration site conditions | 0 | 2 (0.44) | | Infections and infestations | 0 | 8 (1.76) | | Injury, poisoning, and procedural complications | 0 | 3 (0.66) | | Investigations | 0 | 1 (0.22) | | 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) | 4 (0.88) | | Nervous system disorders | 2 (1.27) | 5 (1.10) | | Psychiatric disorders | 0 | 1 (0.22) | | Renal and urinary disorders | 1 (0.64) | 2 (0.44) | | Respiratory, thoracic, and mediastinal disorders | 1 (0.64) | 1 (0.22) | | Skin and subcutaneous tissue disorders | 0 | 1 (0.22) | | Surgical and medical procedures | 0 | 4 (0.88) | | Vascular disorders | 1 (0.64) | 3 (0.66) |
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AE, adverse event; DME, diabetic macular edema.
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