Table 3.
Summary of key TEAEs during the switching period (safety set 2)
| SB15/SB15 | AFL/SB15 | AFL/AFL | |
| N=219, n (%) | N=111, n (%) | N=104, n (%) | |
| Any TEAEs | 80 (36.5) | 39 (35.1) | 31 (29.8) |
| Ocular TEAEs in the study eye | 20 (9.1) | 12 (10.8) | 3 (2.9) |
| Drug-related ocular TEAEs in the study eye | 2 (0.9) | 1 (0.9) | 0 (0.0) |
| Non-ocular TEAEs* | 55 (25.1) | 25 (22.5) | 24 (23.1) |
| Drug-related non-ocular TEAEs | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Ocular AESI† | 3 (1.4) | 0 (0.0) | 1 (1.0) |
| Non-ocular AESI† | 2 (0.9) | 0 (0.0) | 2 (1.9) |
| Serious ocular TEAEs in the study eye | 1 (0.5) | 0 (0.0) | 1 (1.0) |
| Serious non-ocular TEAEs | 9 (4.1) | 6 (5.4) | 5 (4.8) |
| Ocular TEAEs by preferred term in the study eye | |||
| Cataract | 4 (1.8) | 1 (0.9) | 1 (1.0) |
| Visual acuity reduced | 4 (1.8) | 1 (0.9) | 1 (1.0) |
| Dry eye | 2 (0.9) | 0 (0.0) | 0 (0.0) |
| Posterior capsule opacification | 0 (0.0) | 2 (1.8) | 0 (0.0) |
| Retinal tear | 1 (0.5) | 1 (0.9) | 0 (0.0) |
| Xerophthalmia | 0 (0.0) | 2 (1.8) | 0 (0.0) |
| Abnormal sensation in eye | 1 (0.5) | 0 (0.0) | 0 (0.0) |
| Cataract nuclear | 1 (0.5) | 0 (0.0) | 0 (0.0) |
| Corneal dystrophy | 0 (0.0) | 1 (0.9) | 0 (0.0) |
| Corneal oedema | 0 (0.0) | 1 (0.9) | 0 (0.0) |
| Diplopia | 1 (0.5) | 0 (0.0) | 0 (0.0) |
| Disease progression | 0 (0.0) | 1 (0.9) | 0 (0.0) |
| Eye pain | 0 (0.0) | 0 (0.0) | 1 (1.0) |
| Glaucoma | 1 (0.5) | 0 (0.0) | 0 (0.0) |
| Hordeolum | 0 0.0) | 1 (0.9) | 0 (0.0) |
| Intraocular pressure increased | 1 (0.5) | 0 (0.0) | 0 (0.0) |
| Macular degeneration | 1 (0.5) | 0 (0.0) | 0 (0.0) |
| Macular fibrosis | 1 (0.5) | 0 (0.0) | 0 (0.0) |
| Macular hole | 1 (0.5) | 0 (0.0) | 0 (0.0) |
| Macular oedema | 0 (0.0) | 1 (0.9) | 0 (0.0) |
| Neovascular age-related macular degeneration | 0 (0.0) | 1 (0.9) | 0 (0.0) |
| Retinal haemorrhage | 0 (0.0) | 0 (0.0) | 1 (1.0) |
| Retinal pigment epithelial tear | 1 (0.5) | 0 (0.0) | 0 (0.0) |
| Subretinal fluid | 1 (0.5) | 0 (0.0) | 0 (0.0) |
| Vitreous detachment | 0 (0.0) | 0 (0.0) | 1 (1.0) |
| Vitreous floaters | 0 (0.0) | 1 (0.9) | 0 (0.0) |
| Vitreous haemorrhage | 1 (0.5) | 0 (0.0) | 0 (0.0) |
Adverse events were coded according to System Organ Class and PT using MedDRA version 23.0 coding dictionary.
*PTs available in online supplemental table 6.
†PTs available in online supplemental table 4.
AESI, adverse event of special interest; AFL, reference aflibercept; AMD, age-related macular degeneration; MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SB15, aflibercept biosimilar candidate; TEAE, treatment-emergent adverse event.