Summary of all adverse events up to week 52 in the safety set
| SB11 (N=350) n (%) | RBZ (N=354) n (%) | |
| TEAEs | ||
| Any TEAE | 255 (72.9) | 256 (72.3) |
| Ocular TEAEs in the study eye | 112 (32.0) | 105 (29.7) |
| Ocular TEAEs in the fellow eye | 92 (26.3) | 77 (21.8) |
| Non-ocular TEAEs | 194 (55.4) | 205 (57.9) |
| Serious TEAE | 50 (14.3) | 51 (14.4) |
| TEAEs by severity | ||
| Mild TEAEs | 117 (33.4) | 122 (34.5) |
| Moderate TEAEs | 106 (30.3) | 107 (30.2) |
| Severe TEAEs | 32 (9.1) | 27 (7.6) |
| TEAEs by relatedness | ||
| Related TEAEs | 21 (6.0) | 10 (2.8) |
| Not related TEAEs | 234 (66.9) | 246 (69.5) |
| SAEs (by relatedness) | ||
| Any SAE | 52 (14.9) | 52 (14.7) |
| Related SAEs | 6 (1.7) | 3 (0.8) |
| Not related SAEs | 46 (13.1) | 49 (13.8) |
| Serious ocular AE in the study eye (by preferred term) | ||
| Any ocular SAE in the study eye | 10 (2.9) | 8 (2.3) |
| Visual acuity reduced | 2 (0.6) | 1 (0.3) |
| Endophthalmitis | 2 (0.6) | 0 (0.0) |
| Cataract | 2 (0.6) | 0 (0.0) |
| Iridocyclitis | 1 (0.3) | 0 (0.0) |
| Macular oedema | 1 (0.3) | 1 (0.3) |
| Retinal haemorrhage | 1 (0.3) | 1 (0.3) |
| Retinal pigment epithelial tear | 1 (0.3) | 0 (0.0) |
| Subretinal fluid | 1 (0.3) | 1 (0.3) |
| Uveitis | 1 (0.3) | 0 (0.0) |
| Vitritis | 1 (0.3) | 0 (0.0) |
| Cataract subcapsular | 0 (0.0) | 1 (0.3) |
| Macular degeneration | 0 (0.0) | 2 (0.6) |
| Retinal artery occlusion | 0 (0.0) | 1 (0.3) |
| Serious ocular AE in the fellow eye (by preferred term) | ||
| Any ocular SAE in the fellow eye | 3 (0.9) | 2 (0.6) |
| Retinal haemorrhage | 2 (0.6) | 0 (0.0) |
| Age-related macular degeneration | 1 (0.3) | 0 (0.0) |
| Vitreous haemorrhage | 1 (0.3) | 0 (0.0) |
| Choroidal neovascularisation | 0 (0.0) | 1 (0.3) |
| Retinal artery occlusion | 0 (0.0) | 1 (0.3) |
| Serious non-ocular AE (Occurrence ≥0.5% in either treatment group) (by preferred term) | ||
| Any non-ocular SAE | 41 (11.7) | 42 (11.9) |
| Atrial fibrillation | 4 (1.1) | 3 (0.8) |
| Cardiac failure congestive | 2 (0.6) | 2 (0.6) |
| Pancreatitis acute | 0 (0.0) | 2 (0.6) |
| Cystitis | 0 (0.0) | 2 (0.6) |
| Femoral neck fracture | 1 (0.3) | 2 (0.6) |
| Acute kidney injury | 3 (0.9) | 1 (0.3) |
| Chronic obstructive pulmonary disease | 2 (0.6) | 0 (0.0) |
| Hypertension | 3 (0.9) | 0 (0.0) |
| AESI* | 8 (2.3) | 8 (2.3) |
| TEAEs leading to IP discontinuation | ||
| Any TEAEs leading to IP discontinuation | 9 (2.6) | 5 (1.4) |
| Ocular TEAEs in the study eye leading to IP discontinuation | 7 (2.0) | 4 (1.1) |
| Ocular TEAEs in the fellow eye leading to IP discontinuation | 0 (0.0) | 0 (0.0) |
| Non-ocular TEAEs leading to IP discontinuation | 2 (0.6) | 1 (0.3) |
| Deaths | 2 (0.6) | 4 (1.1) |
Percentages are based on the number of participants in the safety set.
Adverse events were coded to System Organ Class and preferred term using medical dictionary for regulatory activities (MedDRA) coding dictionary Version 20.1.
If a participant had multiple events with different severity (or causality), then the participant was counted only once at the worst severity (or worst causality, ie, related) for the number of participants (N).
*Adverse events of special interest were collected using six different categories: category 1, any case of new onset intraocular pressure of >21 mm Hg that does not respond to treatment, except the transient pressure rise observed within an hour after intravitreal injection of IP; category 2, any case of intraocular pressure ≥35 mm Hg, at any time, that required treatment; category 3, any case of intraocular infection such as endophthalmitis; category 4, any case of intraocular inflammation such as iritis, vitritis and iridocyclitis; category 5, Iatrogenic traumatic cataract; category 6, arterial thromboembolic events defined as non-fatal stroke, non-fatal myocardial infarction or vascular death (including deaths of unknown as cause).
AE, adverse event; AESI, adverse event of special interest; IP, investigational product; n, number of participants with event; N, total number of participants; RBZ, reference ranibizumab; SAE, serious adverse event; TEAE, treatment-emergent adverse event.