Table 2.

Therapy-Related Serious Adverse Events

MedDRA SOCa	MedDRA Preferred Term	No. of Serious Events	No. (%) of Patients n = 706b	95% Confidence Interval
Infections and infestations	Subtotal	17	17 (2.41)	1.51–3.82
	Implant site infection	10	10 (1.42)	0.77–2.59
	Medical device site infection	3	3 (0.42)	0.14–1.24
	Wound infection	2	2 (0.28)	0.08–1.03
	Incision site infection	1	1 (0.14)	0.03–0.80
	Meningitis	1	1 (0.14)	0.03–0.80
Psychiatric disorders	Subtotal	5	4 (0.57)	0.22–1.45
	Withdrawal syndrome	5	4 (0.57)	0.22–1.45
Nervous system disorders	Subtotal	9	9 (1.27)	0.67–2.40
	Cerebrospinal fluid leakage	5	5 (0.71)	0.30–1.65
	Headache	2	2 (0.28)	0.08–1.03
	Hypoesthesia	1	1 (0.14)	0.03–0.80
	Spinal cord hematoma	1	1 (0.14)	0.03–0.80
Respiratory, thoracic, and mediastinal disorders	Subtotal	2	2 (0.28)	0.08–1.03
	Acute respiratory failure	1	1 (0.14)	0.03–0.80
	Respiratory failure	1	1 (0.14)	0.03–0.80
General disorders and administration site conditions	Subtotal	29	23 (3.26)	2.18–4.84
	Adverse drug reaction	12	10 (1.42)	0.77–2.59
	Pain	9	8 (1.13)	0.58–2.22
	Drug withdrawal syndrome	7	5 (0.71)	0.30–1.65
	Medical device site hematoma	1	1 (0.14)	0.03–0.80
Injury, poisoning and procedural complications	Subtotal	6	6 (0.85)	0.39–1.84
	Overdose	3	3 (0.42)	0.14–1.24
	Postlumbar puncture syndrome	1	1 (0.14)	0.03–0.80
	Procedural pain	1	1 (0.14)	0.03–0.80
	Wound dehiscence	1	1 (0.14)	0.03–0.80
Totalc		68	54 (7.65)	5.91–9.85

Abbreviations: AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; SOC, System Organ Class.

^ahttps://www.meddra.org/.

^bAE seriousness was added to the registry in April 2010. This table includes AEs categorized as serious in the active patients (n = 706) from April 2010 to July 31, 2017.

^cThe total number of patients with events may not represent the sum of all rows because a patient may have experienced >1 type of event.