TABLE 5.

Serious Adverse Events up to 24 Hours after Last Dose of Study Drug, Safety Population

System Organ Class/	Initial Treatment Arm			Crossover Treatment Arm
Preferred Term	LCM, n = 35	fPHT, n = 37	p	LCM, n = 15	fPHT, n = 10
Patients with at least 1 SAE	5 (14.3%)	4 (10.8%)	0.73	3 (20.0%)	1 (10.0%)
Cardiac disorders	1 (2.9%)	1 (2.7%)	1.0	0	0
Bradycardia	1 (2.9%)	0	0.49	0	0
Atrial tachycardia	0	1 (2.7%)	1.0	0	0
Injury, poisoning, procedural complications	2 (5.7%)	1 (2.7%)	0.61	1 (6.7%)	0
Subdural hematoma	2 (5.7%)	0	0.23	0	0
Toxicity to various agents	0	1 (2.7%)	1.0	1 (6.7%)	0
Nervous system disorders	0	1 (2.7%)	1.0	1 (6.7%)	1 (10.0%)
Cerebral hemorrhage	0	1 (2.7%)	1.0	0	1 (10.0%)
Intracranial pressure increased	0	0	1.0	1 (6.7%)	0
Vascular disorders	2 (5.7%)	1 (2.7%)	0.61	1 (6.7%)	0
Hypotension	2 (5.7%)	1 (2.7%)	0.61	1 (6.7%)	0
Respiratory, thoracic, and mediastinal disorders	1 (2.9%)	0	0.49	0	0
Acute respiratory failure	1 (2.9%)	0	0.49	0	0
Respiratory failure	0	0	1.0	0	0

fPHT = fosphenytoin; LCM = lacosamide; SAE =serious adverse event.