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Table. 4.

Table. 4.

Adverse event reports on cancer immunotherapeutic agents and all other drugs by different characteristics from 2013 to 2017 (number, (%))

Characteristics Number of ICSRs on cetuximab Number of ICSRs on all other CITAs Number of ICSRs on all other drugs p-value
Sex <0.001
Male 1,409 (66.59) 13,402 (48.17) 347,544 (41.55)
Female 707 (33.41) 14,423 (51.83) 507,159 (58.45)
Age group <0.001
0-19 2 (0.09) 220 (0.79) 53,492 (6.16)
20-39 101 (4.77) 2,317 (8.33) 139,852 (16.12)
40-64 1,236 (58.41) 16,566 (59.54) 409,684 (47.21)
Over 65 777 (36.72) 8,722 (31.35) 264,675 (30.51)
Reporter <0.001
Doctor 1,089 (51.91) 15,223 (56.24) 232,143 (26.75)
Pharmacist 104 (4.96) 1,612 (5.96) 115,178 (13.27)
Nurse 681 (32.46) 6,737 (24.89) 435,659 (50.21)
Other health professionals 1 (0.05) 27 (0.10) 1,329 (0.15)
Consumer 217 (10.34) 3,155 (11.66) 44,611 (5.14)
Others 6 (0.29) 313 (1.16) 17,081 (1.98)
NA* 18 (0.85) 758 (2.72) 21,702 (2.50)
Report center <0.001
Regional pharmacovigilance center 902 (42.63) 8,894 (31.96) 649,846 (77.37)
Pharmaceutical company 1,186 (56.05) 18,657 (67.05) 159,712 (19.02)
Clinic 28 (1.32) 240 (0.86) 20,913 (2.49)
Pharmacy 0 (0) 33 (0.12) 1,139 (0.14)
Consumer 0 (0) 0 (0) 6,209 (0.74)
Others 0 (0) 1 (0.00) 2,052 (0.24)
NA* 0 (0) 0 (0) 7 (0.00)
Total 2,116 (100) 27,825 (100) 867,703(100)

*NA: number of missing reports

ICSR, individual case safety report; CITA, cancer immunotherapeutic agent

Korean J Clin Pharm 2022;32:226-37 https://doi.org/10.24304/kjcp.2022.32.3.226
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