Adverse drug reactions associated with six commonly used antiepileptic drugs in southern China from 2003 to 2015

Table 2 General profiles of non-SARs and SARs in this study

Variable	Total (n = 5049)	non-SARs^e (n = 4512)	SARs^e (n = 537)	p-value
Age at ADR occurrence, years (median, (range))	28.0 (7.0–89.0)	28.0 (7.0–89.0)	28.0 (8.0–75.0)	0.349^b
Sex (n, %)				0.006^a
Female	2717 (53.8)	2398 (53.1)	319 (59.4)
Male	2332 (46.2)	2114 (46.9)	218 (40.6)
Number of AEDs related to the ADR^c				< 0.001^a
One (n, %)	2546 (50.4)	2294 (90.1)	252 (9.9)
Two (n, %)	2140 (42.4)	1926 (90.0)	214 (10.0)
Three+ (n, %)	363 (7.2)	292 (80.4)	71 (19.6)
AEDs^d
CBZ (n, %)	1138 (22.5)	1000 (87.9)	138 (12.1)	0.064^a
VPA (n, %)	2493 (49.4)	2228 (89.4)	265 (10.6)	0.989^a
LTG (n, %)	1149 (22.8)	982 (85.5)	167 (14.5)	< 0.001^a
OXC (n, %)	1226 (24.3)	1109 (90.5)	117 (9.5)	0.154^a
TPM (n, %)	1186 (23.5)	1050 (88.5)	136 (11.5)	0.288^a
LEV (n, %)	742 (14.7)	664 (89.5)	78 (10.5)	0.906^a
Dosage/DDD (median, (range))	0.90 (0.07–3.50)	0.90 (0.07–3.50)	0.67 (0.08–2.13)	< 0.001^b
Dosage/DDD groups
≤ 0.50 (n, %)	1061 (21.0)	907 (85.5)	154 (14.5)	< 0.001^a
0.50–1.00 (n, %)	2309 (45.7)	2074 (89.8)	235 (10.2)	0.332^a
1.00–1.50 (n, %)	1088 (21.6)	983 (90.3)	105 (9.7)	0.234^a
1.50–2.00 (n, %)	473 (9.4)	433 (91.5)	40 (8.5)	0.106^a
> 2.00 (n, %)	118 (2.3)	115 (97.5)	3 (2.5)	0.004^a
Level of causality assessment (n, %)
Certain	550 (10.9)	300 (54.5)	250 (45.5)	< 0.001^a
Probable/Likely	796 (15.8)	510 (64.1)	286 35.9)	< 0.001^a
Possible	3509 (69.5)	3508 (99.9)	1 (0.1)	< 0.001^a
Conditional/Unclassified	194 (3.8)	194 (100)	0 (0)	< 0.001^a

ADRs adverse drug reactions, AEDs antiepileptic drugs, SARs severe adverse reactions, DDD defined daily dose
^aPearson chi-square test
^bMann-Whitney U test
^cMultiple comparison, p = 0.05/3 = 0.0167 after Bonferroni correction. Two vs. one p < 0.907; three+ vs. one p < 0.001; three+ vs. two p < 0.001
^dThe sum of the six AEDs was not equal to 5049 due to half of the ADRs being caused by two or three+ AEDs
^eSARs refers to those ADRs requiring withdrawal of the suspected drugs and symptomatic treatment, regardless of whether the suspected drugs were used in mono- or polytherapy

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