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Table. 2.

Table. 2.

Characteristics of individual case safety reports following HPV immunization, according to applicability of the Brighton Collaboration criteria

Category Subcategory Total (n=2,845) N (%) Brighton Collaboration criteria p-value*
Applicable (n=1,511) N (%) Not applicable (n=1,334) N (%)
Gender Male 33 (1.2) 14 (0.9) 19 (1.4) <.001
Female 2,689 (94.5) 1,452 (96.1) 1,237 (92.7)
Unknown 123 (4.3) 45 (3.0) 78 (5.9)

Age 2-11 years 40 (1.4) 28 (1.9) 12 (0.9) <.001
12-19 years 324 (11.4) 182 (12.1) 142 (10.6)
20-65 years 1,285 (45.2) 788 (52.2) 497 (37.3)
unknown 1,196 (42.0) 513 (34.0) 683 (51.2)

Original reporter Physicians 1,624 (57.1) 1,040 (68.8) 584 (43.8) <.001
Pharmacists 32 (1.1) 9 (0.6) 23 (1.7)
Nurses 310 (10.9) 134 (8.9) 176 (13.2)
Consumers 453 (15.9) 184 (12.2) 269 (20.2)
Unknown 137 (4.8) 71 (4.7) 66 (5.0)
Others 289 (10.2) 73 (4.8) 216 (16.2)

Reporter Regional pharmacovigilance left 52 (1.8) 16 (1.1) 36 (2.7) <.001
Manufacturer 2,580 (90.7) 1,405 (93.0) 1,175 (88.1)
Medical institution 4 (0.1) 2 (0.1) 2 (0.2)
Pharmacies 1 (0.0) 0 (0.0) 1 (0.1)
Consumers 156 (5.5) 73 (4.8) 83 (6.2)
Others 52 (1.8) 15 (1.0) 37 (2.8)

Report type Spontaneous report 1,615 (56.8) 635 (42.0) 980 (73.5) <.001
Research (including re-examination) 1,205 (42.4) 869 (57.5) 336 (25.2)
Literature 7 (0.3) 1 (0.1) 6 (0.5)
others 18 (0.6) 6 (0.4) 12 (0.9)

Seriousness Serious 200 (7.4) 97 (6.4) 103 (7.7) 0.18
Death 0 (00) 0 (0.0) 0 (0.0)
Life-threatening 1 (0.0) 0 (0.0) 1 (0.1)
Hospitalization (initial or prolonged) 66 (2.3) 40 (2.6) 26 (1.9)
Disability or permanent damage 8 (0.3) 6 (0.4) 2 (0.1)
Congenital anomaly/birth defect 0 (0.0) 0 (0.0) 0 (0.0)
Other serious (important medical events) 135 (4.7) 59 (3.9) 76 (5.7)
Non-serious 2,645 (93.0) 1,414 (93.6) 1,231 (92.3)

* by chi-square test

Korean J Clin Pharm 2020;30:19-30 https://doi.org/10.24304/kjcp.2020.30.1.19
© 2020 Korean J Clin Pharm