Postmarketing safety surveillance of dexamethasone intravitreal implant in the treatment of visual impairment due to diabetic macular edema in India

Table 3 Treatment-emergent adverse events (> 1 reported event within a system organ class)

MedDRA system organ class/preferred term	Number of patients^a (%)	Number of events^b (%)
All^c	7 (2.8)	22 (8.8)
Investigations	3 (1.2)	6 (2.4)
Intraocular pressure increased	3 (1.2)	6 (2.4)
Cardiac disorders	3 (1.2)	4 (1.6)
Angina pectoris	1 (0.4)	1 (0.4)
Angina unstable	1 (0.4)	1 (0.4)
Cardiac arrest	1 (0.4)	1 (0.4)
Myocardial infarction	1 (0.4)	1 (0.4)
Eye disorders	2 (0.8)	2 (0.8)
Eyelid ptosis	1 (0.4)	1 (0.4)
Glaucoma	1 (0.4)	1 (0.4)
General disorders and administration site conditions	1 (0.4)	2 (0.8)
Pyrexia	1 (0.4)	2 (0.8)
Renal and urinary disorders	1 (0.4)	2 (0.8)
Acute kidney injury	1 (0.4)	1 (0.4)
End-stage renal disease	1 (0.4)	1 (0.4)
Respiratory, thoracic, and mediastinal disorders	1 (0.4)	2 (0.8)
Dyspnea	1 (0.4)	2 (0.8)

AE adverse event; MedDRA Medical Dictionary for Regulatory Activities
^aNumber of patients experiencing each AE; patients who report multiple episodes of the same AE are counted only once. ^bNumber of AEs reported; each reported event is counted, including multiple episodes of the same event by the same patient. ^cCategory encompasses both ocular and nonocular treatment-emergent AE

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