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 3 Ocular and non-ocular AEs^a (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	105 (31.4)	106 (31.5)
- Conjunctival hemorrhage	19 (5.7)	10 (3.0)
- IOP increased	12 (3.6)	21 (6.3)
- Eye pain	10 (3.0)	9 (2.7)
- Dry eye	10 (3.0)	7 (2.1)
- VA reduced	7 (2.1)	1 (0.3)
- Vitreous floaters	6 (1.8)	8 (2.4)
Non-ocular, Total	156 (46.7)	143 (42.6)
- Nasopharyngitis	24 (7.2)	11 (3.3)
- Hypertension	18 (5.4)	16 (4.8)
- Influenza	15 (4.5)	15 (4.5)
- Cough	7 (2.1)	7 (2.1)
- Bronchitis	7 (2.1)	6 (1.8)
- Osteoarthritis	7 (2.1)	6 (1.8)
- Arthralgia	7 (2.1)	5 (1.5)
- Back pain	4 (1.2)	10 (3.0)
- Urinary tract infection	2 (0.6)	7 (2.1)

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
MedDRA Version 18.1 was used for the reporting of AEs
A patient with multiple occurrences of an AE 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, IOP intraocular pressure, MedDRA Medical Dictionary for Regulatory Activities, OCT optical coherence tomography, VA visual acuity
^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

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