Table 2.

Treatment emergent adverse events and treatment related adverse events.

Treatment emergent adverse events (TEAE)	Active	Sham	Treatment related adverse events (TREA)	Active	Sham
System order class	N = 46	N = 28	System order class	N = 46	N = 28
Preferred term	n (%)	n (%)		n (%)	n (%)
Number of subjects with any TEAE	30 (65.2)	20 (71.4)	Headache	10 (21.7)	3 (10.7)
Ear and labyrinth disorders	9 (19.6)	0 (0.0)	Tinnitus	7 (15.2)	0 (0.0)
Tinnitus	7 (15.2)	0 (0.0)	Eye pain	0 (0.0)	2 (7.1)
Eye disorders	3 (6.5)	3 (10.7)	Disorientation	0 (0.0)	2 (7.1)
Eye pain	0 (0.0)	2 (7.1)
Gastrointestinal disorders	3 (6.5)	3 (10.7)
General disorders and administration site conditions	2 (4.3)	4 (14.3)
Oedema	0 (0.0)	2 (7.1)
Infections and infestations	7 (15.2)	7 (25.0)
Nasopharyngitis	0 (0.0)	6 (21.4)
Injury, poisoning and procedural complications	2 (4.3)	2 (7.1)
Skin abrasion	0 (0.0)	4 (14.3)
Investigations	3 (6.5)	0 (0.0)
Musculoskeletal and connective tissue disorders	6 (13.0)	1 (3.6)
Nervous system disorders	14 (30.4)	10 (35.7)
Headache	10 (21.7)	4 (14.3)
Agitation	2 (4.3)	2 (7.1)
Dizziness	2 (4.3)	2 (7.1)
Disorientation	0 (0.0)	2 (7.1)
Psychiatric disorders	7 (15.2)	4 (14.3)
Anxiety	1 (2.2)	2 (7.1)
Restlessness	0 (0.0)	2 (7.1)
Respiratory, thoracic and mediastinal disorders	1 (2.2)	2 (7.1)
Skin and subcutaneous tissue disorders	4 (8.7)	0 (0.0)