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Table 2 Ocular and non-ocular serious AEs (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, Total2 (0.6)4 (1.2)
 - VA reduced1 (0.3)1 (0.3)
 - VA tests abnormal1 (0.3)0
 - Choroidal hemorrhage01 (0.3)
 - Encephalitis post varicella01 (0.3)
 - Retinal artery embolism01 (0.3)
Non-ocular, Totala27 (8.1)43 (12.8)
 - Osteoarthritis2 (0.6)1 (0.3)
 - Syncope2 (0.6)0
 - Femoral neck fracture1 (0.3)4 (1.2)
 - Lower respiratory tract infection1 (0.3)2 (0.6)
 - Atrial fibrillation03 (0.9)
 - Hypertension02 (0.6)
 - Ovarian cyst02 (0.6)
 - Pneumonia03 (0.9)
  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 adverse event 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, MedDRA Medical Dictionary for Regulatory Activities, OCT optical coherence tomography, VA visual acuity
  6. aEvents reported in ≥2 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