Table 5.

Nonocular Serious Adverse Events by System Organ Class. Preferred Term, and Treatment Arm

	Treatment Group
	Sham		Human Ciliary Neurotrophic Factor Neurotech-501 Implant		Human Ciliary Neurotrophic Factor Neurotech-501 Implant plus Sham		All Participants
System Organ Class Preferred Term	Participants with Event, No. (%)	No. of Total Events	Participants with Event, No. (%)	No. of Total Events	Participants with Event, No. (%)	No. of Total Events	Participants with Event, No. (%)	No. of Total Events
Cardiac disorders	1 (5.3)	1	0	0	2 (6.3)	2	3 (4.5)	3
Atrial fibrillation	0	0	0	0	1 (3.1)	1	1 (1.5)	1
Cardiac arrest	0	0	0	0	1 (3.1)	1	1 (1.5)	1
Stress cardiomyopathy	1 (5.3)	1	0	0	0	0	1 (1.5)	1
Endocrine disorders	0	0	0	0	1 (3.1)	1	1 (1.5)	1
Thyroid mass	0	0	0	0	1 (3.1)	1	1 (1.5)	1
Infections and infestations	1 (5.3)	1	0	0	1 (3.1)	1	2 (3)	2
Pneumonia	1 (5.3)	1	0	0	1 (3.1)	1	2 (3)	2
Injury, poisoning, and procedural complications	0	0	0	0	1 (3.1)	1	1 (1.5)	1
Postlaminectomy syndrome	0	0	0	0	1 (3.1)	1	1 (1.5)	1
Nervous system disorders	0	0	1 (6.3)	1	0	0	1 (1.5)	1
Normal pressure hydrocephalus	0	0	1 (6.3)	1	0	0	1 (1.5)	1
Psychiatric disorders	1 (5.3)	1	0	0	1 (3.1)	1	2 (3)	2
Anxiety	0	0	0	0	1 (3.1)	1	1 (1.5)	1
Suicide attempt	1 (5.3)	1	0	0	0	0	1 (1.5)	1
Respiratory, thoracic, and mediastinal disorders	0	0	1 (6.3)	1	0	0	1 (1.5)	1
Laryngeal cyst	0	0	1 (6.3)	1	0	0	1 (1.5)	1
Surgical and medical procedures	0	0	0	0	1 (3.1)	1	1 (1.5)	1
Vulval operation	0	0	0	0	1 (3.1)	1	1 (1.5)	1
Vascular disorders	1 (5.3)	1	1 (6.3)	1	0	0	2 (3)	2
Aortic aneurysm	0	0	1 (6.3)	1	0	0	1 (1.5)	1
Shock	1 (5.3)	1	0	0	0	0	1 (1.5)	1