ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
Characteristics of reports on warfarin, statin, concomitant and all other drugs
| Characteristics | Warfarin only (N=4,203) | Statin only (N=24,365) | Concomitant (N=648) | All other drugs (N=927,856) | p-value | ||||
|---|---|---|---|---|---|---|---|---|---|
| N | % | N | % | N | % | N | % | ||
| Sex | <.0001 | ||||||||
| Male | 2,215 | (52.70) | 11,508 | (47.23) | 349 | (53.86) | 371,650 | (40.05) | |
| Female | 1,988 | (47.30) | 12,857 | (52.77) | 299 | (46.14) | 556,206 | (59.95) | |
| Age | <.0001 | ||||||||
| 0-19 | 18 | (0.43) | 44 | (0.18) | 0 | (0.00) | 48,529 | (5.23) | |
| 20-39 | 133 | (3.16) | 649 | (2.66) | 10 | (1.54) | 148,332 | (15.99) | |
| 40-64 | 1,338 | (31.83) | 11,882 | (48.77) | 195 | (30.09) | 433,816 | (46.75) | |
| 65 | 2,714 | (64.57) | 11,790 | (48.39) | 443 | (68.36) | 297,179 | (32.03) | |
| Year | <.0001 | ||||||||
| 2016 | 1,086 | (25.84) | 4,429 | (18.18) | 205 | (31.64) | 169,722 | (18.29) | |
| 2017 | 1,091 | (25.96) | 5,563 | (22.83) | 77 | (11.88) | 190,002 | (20.48) | |
| 2018 | 929 | (22.10) | 4,765 | (19.56) | 261 | (40.28) | 186,247 | (20.07) | |
| 2019 | 731 | (17.39) | 4,323 | (17.74) | 41 | (6.33) | 193,025 | (20.80) | |
| 2020 | 366 | (8.71) | 5,285 | (21.69) | 64 | (9.88) | 188,860 | (20.35) | |
| Report type | <.0001 | ||||||||
| Spontaneous report | 3,481 | (82.82) | 10,347 | (42.47) | 93 | (14.35) | 848,090 | (91.40) | |
| Research (including PMS) | 673 | (16.01) | 13,894 | (57.02) | 551 | (85.03) | 60,983 | (6.57) | |
| Literature | 39 | (0.93) | 101 | (0.41) | 4 | (0.62) | 5,653 | (0.61) | |
| Unkwon | 0 | (0.00) | 0 | (0.00) | 0 | (0.00) | 4 | (0.00) | |
| Others | 10 | (0.24) | 23 | (0.09) | 0 | (0.00) | 13,126 | (1.41) | |
| Original reporter | <.0001 | ||||||||
| Healthcare professionals1) | 3,550 | (84.46) | 22,142 | (90.88) | 602 | (92.90) | 858,472 | (92.52) | |
| Consumers | 138 | (3.28) | 348 | (1.43) | 7 | (1.08) | 34,222 | (3.69) | |
| Others2) | 483 | (11.49) | 85 | (0.35) | 2 | (0.31) | 21,812 | (2.35) | |
| Unknown | 32 | (0.76) | 1,790 | (7.35) | 37 | (5.71) | 13,350 | (1.44) | |
| Reporter | <.0001 | ||||||||
| Regional harmpacovigilance centers | 3,436 | (81.75) | 9,891 | (40.60) | 88 | (13.58) | 788,594 | (84.99) | |
| Manufacturer | 733 | (17.44) | 14,327 | (58.80) | 559 | (86.27) | 101,590 | (10.95) | |
| Medical titutiionns | 32 | (0.76) | 109 | (0.45) | 1 | (0.15) | 32,859 | (3.54) | |
| Pharmacy | 0 | (0.00) | 1 | (0.00) | 0 | (0.00) | 38 | (0.00) | |
| Public health enter | 0 | (0.00) | 0 | (0.00) | 0 | (0.00) | 1 | (0.00) | |
| Consumer | 1 | (0.02) | 26 | (0.11) | 0 | (0.00) | 2,152 | (0.23) | |
| Others | 1 | (0.002) | 11 | (0.05) | 0 | (0.00) | 2,622 | (0.28) | |
| Serious adverse event | <.0001 | ||||||||
| Yes | 543 | (12.92) | 3,752 | (15.40) | 104 | (16.05) | 55,351 | (5.97) | |
| No | 3,660 | (87.08) | 20,613 | (84.60) | 544 | (83.95) | 872,505 | (94.03) | |
1)Including doctors, pharmacists and nurses; 2)Others, including attorneys and other medical professionals.
PMS: post-marketing surveillance.