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

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

Variable Total (n = 5049) non-SARse (n = 4512) SARse (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) 0.349b
Sex (n, %)     0.006a
 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 ADRc     <  0.001a
 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)  
AEDsd
 CBZ (n, %) 1138 (22.5) 1000 (87.9) 138 (12.1) 0.064a
 VPA (n, %) 2493 (49.4) 2228 (89.4) 265 (10.6) 0.989a
 LTG (n, %) 1149 (22.8) 982 (85.5) 167 (14.5) <  0.001a
 OXC (n, %) 1226 (24.3) 1109 (90.5) 117 (9.5) 0.154a
 TPM (n, %) 1186 (23.5) 1050 (88.5) 136 (11.5) 0.288a
 LEV (n, %) 742 (14.7) 664 (89.5) 78 (10.5) 0.906a
Dosage/DDD (median, (range)) 0.90 (0.07–3.50) 0.90 (0.07–3.50) 0.67 (0.08–2.13) <  0.001b
Dosage/DDD groups
  ≤ 0.50 (n, %) 1061 (21.0) 907 (85.5) 154 (14.5) <  0.001a
 0.50–1.00 (n, %) 2309 (45.7) 2074 (89.8) 235 (10.2) 0.332a
 1.00–1.50 (n, %) 1088 (21.6) 983 (90.3) 105 (9.7) 0.234a
 1.50–2.00 (n, %) 473 (9.4) 433 (91.5) 40 (8.5) 0.106a
  > 2.00 (n, %) 118 (2.3) 115 (97.5) 3 (2.5) 0.004a
Level of causality assessment (n, %)
 Certain 550 (10.9) 300 (54.5) 250 (45.5) <  0.001a
 Probable/Likely 796 (15.8) 510 (64.1) 286 35.9) <  0.001a
 Possible 3509 (69.5) 3508 (99.9) 1 (0.1) <  0.001a
 Conditional/Unclassified 194 (3.8) 194 (100) 0 (0) < 0.001a
  1. ADRs adverse drug reactions, AEDs antiepileptic drugs, SARs severe adverse reactions, DDD defined daily dose
  2. aPearson chi-square test
  3. bMann-Whitney U test
  4. 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
  5. dThe sum of the six AEDs was not equal to 5049 due to half of the ADRs being caused by two or three+ AEDs
  6. 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