Table 2

Systemic drug-related adverse events (by Preferred Term) and systemic adverse events of special interest (by Safety Risk and Preferred Term; Safety set*)

Preferred term, n (%)	Total (N=936)	Unilaterally treated (n=879)	Bilaterally treated (n=113)
Patients with at least one drug-related AE	3 (0.3)	3 (0.3)	0
Angina pectoris	1 (0.1)	1 (0.1)	0
Cerebral haemorrhage	1 (0.1)	1 (0.1)	0
TIA	1 (0.1)	1 (0.1)	0
Patients with at least one systemic AESI	18 (1.9)	16 (1.8)	2 (1.8)
Hypertension	5 (0.5)	4 (0.5)	1 (0.9)
Blood pressure fluctuation	1 (0.1)	0	1 (0.9)
Blood pressure increased	2 (0.2)	2 (0.2)	0
Hypertension	2 (0.2)	2 (0.2)	0
Myocardial infarction	1 (0.1)	1 (0.1)	0
Non-myocardial arterial thromboembolic events	5 (0.5)	5 (0.6)	0
Cerebral haemorrhage	1 (0.1)	1 (0.1)	0
Cerebrovascular accident	1 (0.1)	1 (0.1)	0
TIA	3 (0.3)	3 (0.3)	0
Non-ocular haemorrhage	6 (0.6)	5 (0.6)	1 (0.9)
Cerebral haemorrhage	1 (0.1)	1 (0.1)	0
Epistaxis	1 (0.1)	1 (0.1)	0
Haematuria	1 (0.1)	1 (0.1)	0
Haematuria traumatic	1 (0.1)	1 (0.1)	0
Intestinal haemorrhage	1 (0.1)	1 (0.1)	0
Varicose vein ruptured	1 (0.1)	0	1 (0.9)
Venous thromboembolic events	2 (0.2)	2 (0.2)	0
Pulmonary embolism	2 (0.2)	2 (0.2)	0

The preferred term, 'Cerebral haemorrhage' was classified in both Safety Risks 'Non-ocular haemorrhage' and 'Non-myocardial arterial thromboembolic events’. Each patient could experience more than one adverse event of special interest. Patients were counted only once in each row. Terms were coded using MedDRA dictionary, version 18.1.
*Consisted of all enrolled patients who signed the informed consent, received at least one dose of study drug and had at least one postbaseline safety assessment.
AE, adverse event; AESI, adverse event of special interest; MedDRA, Medical Dictionary for Drug Regulatory Activities; SOC, system organ class; TIA, transient ischaemic attack.