Table 2. Ocular and non-ocular AEs in prior ranibizumab-treated patients with nAMD.
| Prior ranibizumab-treated group (N = 16,167) | |
|---|---|
| Preferred term | n, (%) |
| Ocular AEs† | |
| Total | 2148 (13.29) |
| Cataract | 359 (2.22) |
| IOP increased | 247 (1.53) |
| Eye pain | 218 (1.35) |
| Dry eye | 146 (0.90) |
| Blepharitis | 146 (0.90) |
| Vitreous floaters | 149 (0.92) |
| Visual acuity reduced | 124 (0.77) |
| Conjunctivitis | 97 (0.60) |
| Conjunctival hemorrhage | 93 (0.58) |
| Posterior capsule opacification | 84 (0.52) |
| Non-ocular AEs† | |
| Total | 3721 (23.02) |
| Fall | 290 (1.79) |
| Death | 218 (1.35) |
| Pneumonia | 216 (1.34) |
| Lower respiratory tract infection | 216 (1.34) |
| Urinary tract infection | 178 (1.10) |
| Nasopharyngitis | 163 (1.01) |
| Hypertension | 134 (0.83) |
| Atrial fibrillation | 121 (0.75) |
| Cerebrovascular accident | 116 (0.72) |
| Osteoarthritis | 114 (0.71) |
| Constipation | 100 (0.62) |
| Myocardial infarction | 91 (0.56) |
| Angina pectoris | 84 (0.52) |
| Arthralgia | 92 (0.57) |
| Anemia | 83 (0.51) |
These are cumulative data for nAMD patients who have completed observational periods of 1 year, 2 years, 3 years, and 4 years in LUMINOUS.
†Primary treated eye, ocular and non-ocular AEs ≥0.5%, for the total nAMD patients are shown.
The 95% confidence interval values were calculated only for AEs related to identified and potential risks that included: IOP increased (1.34, 1.73), hypertension (0.70, 0.98), cerebrovascular accident (0.59, 0.86), and myocardial infarction (0.45, 0.69).
AEs, adverse event (a patient with multiple occurrences of an AE is counted once per preferred term);
N, total number of patients; n, number of patients; nAMD, neovascular age-related macular degeneration.