Table 1 Characteristics of the AE reports of infliximab and methotrexate in the KAERS between 2009 and 2018.
Characteristics | Infliximab | Methotrexate | P value | ||
|---|---|---|---|---|---|
N = 4482 | 100.00 (%) | N = 6894 | 100.00 (%) | ||
Gender | < .0001 | ||||
Male | 2002 | 44.7 | 2563 | 37.2 | Â |
Female | 1929 | 43.0 | 4144 | 60.1 | Â |
Unknown | 551 | 12.3 | 187 | 2.7 | Â |
Age group (year) | < .0001 | ||||
< 20 | 413 | 9.2 | 1635 | 23.7 |  |
20–29 | 486 | 10.8 | 387 | 5.6 |  |
30–39 | 735 | 16.4 | 611 | 8.9 |  |
40–49 | 650 | 14.5 | 841 | 12.2 |  |
50–59 | 666 | 14.9 | 1208 | 17.5 |  |
60–69 | 449 | 10.0 | 960 | 13.9 |  |
≥ 70 | 233 | 5.2 | 544 | 7.9 |  |
Unknown | 850 | 19.0 | 708 | 10.3 | Â |
Report year | < .0001 | ||||
2009 | 16 | 0.4 | 68 | 1.0 | Â |
2010 | 77 | 1.7 | 219 | 3.2 | Â |
2011 | 136 | 3.0 | 290 | 4.2 | Â |
2012 | 122 | 2.7 | 642 | 9.3 | Â |
2013 | 264 | 5.9 | 852 | 12.4 | Â |
2014 | 521 | 11.6 | 747 | 10.8 | Â |
2015 | 631 | 14.1 | 686 | 10.0 | Â |
2016 | 1608 | 35.9 | 971 | 14.1 | Â |
2017 | 670 | 15.0 | 1137 | 16.5 | Â |
2018 | 437 | 9.8 | 1282 | 18.6 | Â |
Serious AE | < .0001 | ||||
Yes | 1255 | 28.0 | 1257 | 18.2 | Â |
Report type | < .0001 | ||||
Spontaneous | 1244 | 27.8 | 5605 | 81.3 | Â |
Post-marketing surveillance | 2718 | 60.6 | 38 | 0.6 | Â |
Literature | 404 | 9.0 | 542 | 7.9 | Â |
Others | 116 | 2.6 | 709 | 10.3 | Â |
Report Source by person | < .0001 | ||||
Physician | 3351 | 74.8 | 1696 | 24.6 | Â |
Pharmacist | 67 | 1.5 | 987 | 14.3 | Â |
Nurse | 493 | 11.0 | 3126 | 45.3 | Â |
Consumer | 112 | 2.5 | 96 | 1.4 | Â |
Healthcare professional | 6 | 0.1 | 110 | 1.6 | Â |
Others | 80 | 1.8 | 438 | 6.4 | Â |
Unknown | 373 | 8.3 | 441 | 6.4 | Â |
Report Source by Affiliation | < .0001 | ||||
RPVC | 632 | 14.1 | 6124 | 88.8 | Â |
Manufacturer | 3733 | 83.3 | 676 | 9.8 | Â |
Medical institution | 37 | 0.8 | 85 | 1.2 | Â |
Pharmacy | 1 | 0 | 5 | 0.1 | Â |
Consumer | 0 | 0 | 3 | 0 | Â |
Others | 79 | 1.8 | 1 | 0 | Â |
