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Table 3 Ocular and non-ocular AEsa (safety set)

From: Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration – results from the randomized, phase IIIb OCTAVE study

Preferred term, n (%)Ranibizumab 0.5 mg
VA only (Group I)
N = 334
Ranibizumab 0.5 mg
VA and/or OCT (Group II)
N = 336
Ocular, Total105 (31.4)106 (31.5)
 - Conjunctival hemorrhage19 (5.7)10 (3.0)
 - IOP increased12 (3.6)21 (6.3)
 - Eye pain10 (3.0)9 (2.7)
 - Dry eye10 (3.0)7 (2.1)
 - VA reduced7 (2.1)1 (0.3)
 - Vitreous floaters6 (1.8)8 (2.4)
Non-ocular, Total156 (46.7)143 (42.6)
 - Nasopharyngitis24 (7.2)11 (3.3)
 - Hypertension18 (5.4)16 (4.8)
 - Influenza15 (4.5)15 (4.5)
 - Cough7 (2.1)7 (2.1)
 - Bronchitis7 (2.1)6 (1.8)
 - Osteoarthritis7 (2.1)6 (1.8)
 - Arthralgia7 (2.1)5 (1.5)
 - Back pain4 (1.2)10 (3.0)
 - Urinary tract infection2 (0.6)7 (2.1)
  1. The safety set consisted of all patients who received at least one application of study drug and had at least one post-baseline safety assessment
  2. MedDRA Version 18.1 was used for the reporting of AEs
  3. A patient with multiple occurrences of an AE under one treatment was counted only once in the AEs category
  4. Preferred terms are sorted by descending order of incidence in Group I column
  5. AE adverse event, IOP intraocular pressure, MedDRA Medical Dictionary for Regulatory Activities, OCT optical coherence tomography, VA visual acuity
  6. aReported in ≥2% of patients in any group. Treatment exposure: The mean (SD) number of injections for the overall population (safety set) was 7.3 (2.67) and 7.6 (2.98) in Groups I and II, respectively; the median number of injections was 7.0 in both groups