Table 2.

Adverse reactions by MedDRA system organ classification

	Number of events			Number of patients (%)
	Lamotrigine	Levetiracetam	Zonisamide	Lamotrigine (n=328)	Levetiracetam (n=330)	Zonisamide (n=324)
Psychiatric disorders	58	147	103	43 (13%)	98 (30%)	73 (23%)
Nervous system disorders	88	81	85	53 (16%)	55 (17%)	60 (19%)
General disorders and administration site conditions*	23	37	44	17 (5%)	32 (10%)	39 (12%)
Gastrointestinal disorders	30	29	35	25 (8%)	22 (7%)	26 (8%)
Skin and subcutaneous tissue disorders†	29	14	28	24 (7%)	12 (4%)	21 (7%)
Investigations	6	11	16	6 (2%)	11 (3%)	16 (5%)
Metabolism and nutrition disorders	4	2	17	3 (1%)	2 (1%)	16 (5%)
Musculoskeletal and connective tissue disorders	5	1	8	5 (2%)	1 (<1%)	7 (2%)
Eye disorders	1	1	5	1 (<1%)	1 (<1%)	5 (2%)
Renal and urinary disorders	1	0	6	1 (<1%)	0	5 (2%)
Cardiac disorders	2	2	1	2 (<1%)	2 (1%)	1 (<1%)
Respiratory, thoracic, and mediastinal disorders	1	1	2	1 (<1%)	1 (<1%)	2 (1%)
Injury, poisoning, and procedural complications	2	0	0	2 (1%)	0	0
Ear and labyrinth disorders	0	1	0	0	1 (<1%)	0
Endocrine disorders	0	1	0	0	1 (<1%)	0
Pregnancy, puerperium, and perinatal conditions	0	0	1	0	0	1 (<1%)
Vascular disorders	1	0	0	1 (<1%)	0	0
Total events and patients with at least one adverse reaction	251	328	351	108 (33%)	144 (44%)	146 (45%)

^*88 (85%) of 104 adverse reactions in this category were fatigue.

^†42 events were rash: 22 events in the lamotrigine group, eight events in the levetiracetam group, and 12 events in the zonisamide group. Two of these were categorised as severe: one dermatitis allergic in the lamotrigine group and one Stevens Johnson syndrome in the levetiracetam group.