Intravitreal aflibercept for the treatment of patients with diabetic macular edema in routine clinical practice in Latin America: the AQUILA study

Table 3 Safety overview (SAF)

Number of patients (%)	Safety analysis set N = 319
Any AE^a	42 (13.2)
Ocular AEs^b	30 (9.4)
Vitreous hemorrhage	8 (2.5)
Worsening of diabetic retinopathy	6 (1.9)
Cataract	3 (0.9)
Glaucoma	3 (0.9)
Treatment-related ocular AEs	6 (1.9)
Serious ocular AEs	6 (1.9)
Treatment-related serious ocular AEs	1 (0.3)
Non-ocular AEs	16 (5.0)
Treatment-related non-ocular AEs	0
Serious non-ocular AEs^c	12 (3.8)
Deaths^d	7 (2.2)

AE adverse event, IVT-AFL intravitreal aflibercept, SAF safety analysis set
^aAEs are those reported if they started after the first IVT-AFL injection and not later than 30 days after the last IVT-AFL injection. If no unambiguous allocation is possible because of missing parts of the AE start date, for example, the AE will be treated as an AE (worst case scenario)
^bOcular AEs reported by preferred term in ≥ 3 patients
^cDeemed to be unrelated to treatment according to the responsible physician
^dThe cause of death was unknown for 3 patients; and the 4 other deaths were deemed to be unrelated to treatment according to the responsible physician

ISSN: 2056-9920