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

Table 2 Ocular and non-ocular serious AEs (safety set)

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, Total	2 (0.6)	4 (1.2)
- VA reduced	1 (0.3)	1 (0.3)
- VA tests abnormal	1 (0.3)	0
- Choroidal hemorrhage	0	1 (0.3)
- Encephalitis post varicella	0	1 (0.3)
- Retinal artery embolism	0	1 (0.3)
Non-ocular, Total^a	27 (8.1)	43 (12.8)
- Osteoarthritis	2 (0.6)	1 (0.3)
- Syncope	2 (0.6)	0
- Femoral neck fracture	1 (0.3)	4 (1.2)
- Lower respiratory tract infection	1 (0.3)	2 (0.6)
- Atrial fibrillation	0	3 (0.9)
- Hypertension	0	2 (0.6)
- Ovarian cyst	0	2 (0.6)
- Pneumonia	0	3 (0.9)

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
MedDRA Version 18.1 was used for the reporting of AEs
A patient with multiple occurrences of an adverse event under one treatment was counted only once in the AEs category
Preferred terms are sorted by descending order of incidence in Group I column
AE adverse event, MedDRA Medical Dictionary for Regulatory Activities, OCT optical coherence tomography, VA visual acuity
^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

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