ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
| Characteristics | America (N, %) | Europe (N, %) | Asia (N, %) | Other regions (N, %) | ||||
|---|---|---|---|---|---|---|---|---|
| Cases | Non-cases | Cases | Non-cases | Cases | Non-cases | Cases | Non-cases | |
| No. of reports | 454 (0.86) | 52,359 (99.14) | 241 (1.14) | 20,966 (98.86) | 56 (1.13) | 4,910(98.87) | 6(0.82) | 723 (99.18) |
| Age (years) | ||||||||
| 18-44 | 60 (13.22) | 4,387 (8.38) | 42 (17.43) | 2,555 (12.19) | 4 (7.14) | 1,247 (25.40) | 4 (66.67) | 334 (46.20) |
| 45-64 | 245 (53.96) | 26,634 (50.87) | 107 (44.40) | 11,067 (52.97) | 17 (30.36) | 2,277 (46.37) | 2 (33.33) | 323 (44.67) |
| 65-74 | 118 (25.99) | 15,665 (29.92) | 71 (29.46) | 5,544 (26.44) | 17 (30.36) | 696 (14.18) | 0 (0.00) | 57 (7.88) |
| ≥75 | 31 (6.83) | 5,673 (10.83) | 21 (8.71) | 1,800 (8.59) | 18 (32.14) | 690 (14.05) | 0 (0.00) | 9 (1.24) |
| Sex | ||||||||
| Male | 202 (44.49) | 21,093 (40.29) | 106 (43.98) | 9,217 (43.96) | 33 (58.93) | 2,071 (42.18) | 1 (16.67) | 230 (31.81) |
| Female | 252 (55.510 | 31,266 (59.71) | 135 (56.02) | 11,749 (56.04) | 23 (41.07) | 2,839 (57.82) | 5 (83.33) | 493 (68.19) |
| Report type | ||||||||
| Spontaneous | 406 (89.43) | 51,292 (97.96) | 207 (85.89) | 17,079 (81.46) | 44 (78.57) | 2,164 (44.07) | 4 (66.67) | 533 (73.72) |
| Report from study | 39 (8.59) | 685 (1.31) | 34 (14.11) | 3,878 (18.50) | 12 (21.43) | 1,298 (26.44) | 2 (33.33) | 189 (26.14) |
| Other | 1 (0.22) | 295 (0.56) | 0 (0.00) | 9 (0.04) | 0 (0.00) | 130 (2.65) | 0 (0.00) | 1 (0.14) |
| Unknown | 8 (1.76) | 87 (0.17) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 1,918 (26.84) | 0 (0.00) | 0 (0.00) |
| Seriousness* | ||||||||
| Yes | 416 (91.63) | 11,193 (21.38) | 194 (80.50) | 5,955 (28.40) | 49 (87.50) | 1,302 (26.52) | 4 (66.67) | 134 (18.53) |
| No | 36 (7.93) | 40,731 (77.79,) | 46 (19.09) | 14,950 (71.31) | 5 (8.93) | 3,475 (70.77) | 1 (16.67) | 543 (75.10) |
| Unknown | 2 (0.44) | 435 (0.83) | 1 (0.41) | 61 (0.29) | 2 (3.57) | 133 (2.71) | 1 (16.67) | 46 (6.36) |
| Notifier | ||||||||
| Physician | 149 (32.82) | 4,968 (9.49) | 150 (62.24) | 10,301 (49.13) | 44 (78.57) | 2,038 (41.51) | 1 (16.67) | 213 (29.46) |
| Pharmacist | 7 (1.54) | 1,080 (2.06) | 16 (6.64) | 2,403 (11.46) | 1 (1.79) | 314 (6.40) | 0 (0.00) | 48 (6.64) |
| Others | 298 (65.64) | 46,311 (88.45) | 75 (31.12) | 8,262 (39.41) | 11 (19.64) | 2,558 (52.10) | 5 (83.33) | 462 (63.90) |
*Fatal, Life-threatening, requiring hospitalization, resulting in significant disability/incapacity, and other medically important conditions