Table 3 Top 50 frequency of positive adverse events at the PT level for CZP.
From: A real-world pharmacovigilance study of Certolizumab pegol based on FAERS database
PT | N. of events | ROR (95% CI) | PRR (95% CI) | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|
Rheumatoid arthritis | 5880 | 14.72(14.34, 15.12) | 14.35(14.07, 14.63) | 3.76(3.72) | 13.55(13.25) |
Maternal exposure during Pregnancy | 3305 | 10.55(10.18, 10.92) | 10.4(10, 10.82) | 3.32(3.27) | 9.99(9.7) |
Crohn’s disease | 2648 | 11.31(10.87, 11.76) | 11.18(10.75, 11.63) | 3.42(3.36) | 10.7(10.36) |
Psoriasis | 2620 | 5.27(5.07, 5.48) | 5.21(5.01, 5.42) | 2.36(2.3) | 5.12(4.96) |
Psoriatic arthropathy | 1899 | 13.84(13.21, 14.5) | 13.73(13.2, 14.28) | 3.7(3.63) | 13(12.5) |
Infection | 1827 | 3.46(3.3, 3.63) | 3.44(3.31, 3.58) | 1.77(1.7) | 3.4(3.27) |
Ankylosing spondylitis | 1806 | 46.01(43.74, 48.41) | 45.64(43.03, 48.4) | 5.25(5.18) | 38.14(36.55) |
Sinusitis | 1495 | 3.87(3.68, 4.07) | 3.85(3.63, 4.08) | 1.93(1.85) | 3.8(3.64) |
Maternal exposure before pregnancy | 1394 | 71.93(67.72, 76.41) | 71.48(67.4, 75.81) | 5.77(5.68) | 54.54(51.85) |
Lower respiratory tract infection | 1213 | 7.53(7.11, 7.97) | 7.49(7.06, 7.94) | 2.86(2.78) | 7.28(6.94) |
Intentional dose omission | 1006 | 12.64(11.86, 13.47) | 12.58(11.86, 13.34) | 3.58(3.49) | 11.97(11.35) |
Bronchitis | 933 | 3.29(3.09, 3.51) | 3.28(3.09, 3.48) | 1.7(1.61) | 3.25(3.08) |
Herpes zoster | 874 | 4(3.74, 4.27) | 3.99(3.76, 4.23) | 1.98(1.88) | 3.93(3.72) |
Injection site discolouration | 638 | 14.59(13.47, 15.81) | 14.55(13.45, 15.74) | 3.78(3.66) | 13.73(12.84) |
Maternal exposure during breast feeding | 637 | 61.7(56.52, 67.36) | 61.52(56.88, 66.54) | 5.6(5.48) | 48.57(45.13) |
Upper respiratory tract infection | 628 | 3.67(3.39, 3.97) | 3.66(3.38, 3.96) | 1.86(1.74) | 3.62(3.39) |
Cellulitis | 597 | 3.16(2.92, 3.43) | 3.16(2.92, 3.42) | 1.64(1.53) | 3.13(2.92) |
Abortion spontaneous | 586 | 4.06(3.74, 4.4) | 4.05(3.74, 4.38) | 2(1.88) | 4(3.73) |
Therapeutic response shortened | 556 | 5.63(5.17, 6.12) | 5.62(5.2, 6.08) | 2.46(2.34) | 5.5(5.13) |
Pregnancy | 512 | 8.25(7.55, 9.01) | 8.23(7.61, 8.9) | 3(2.87) | 7.98(7.41) |
Systemic lupus erythematosus | 422 | 3.49(3.17, 3.85) | 3.49(3.16, 3.85) | 1.79(1.65) | 3.45(3.18) |
Frequent bowel movements | 411 | 4.3(3.9, 4.74) | 4.29(3.89, 4.73) | 2.08(1.94) | 4.23(3.9) |
Tuberculosis | 402 | 8.85(8.01, 9.78) | 8.83(8.01, 9.74) | 3.09(2.95) | 8.54(7.86) |
Ear infection | 394 | 4.01(3.63, 4.43) | 4.01(3.64, 4.42) | 1.98(1.84) | 3.95(3.64) |
Fungal infection | 387 | 3.11(2.81, 3.43) | 3.1(2.81, 3.42) | 1.62(1.47) | 3.07(2.83) |
Injection site rash | 371 | 3.45(3.11, 3.82) | 3.44(3.12, 3.79) | 1.77(1.62) | 3.4(3.12) |
Premature baby | 364 | 3.18(2.87, 3.53) | 3.18(2.88, 3.51) | 1.65(1.51) | 3.15(2.89) |
Sars-cov-2 test positive | 340 | 6.26(5.62, 6.98) | 6.26(5.68, 6.9) | 2.61(2.46) | 6.11(5.59) |
Localised infection | 333 | 3.62(3.25, 4.04) | 3.62(3.22, 4.07) | 1.84(1.68) | 3.58(3.27) |
Premature delivery | 331 | 5.19(4.65, 5.79) | 5.18(4.61, 5.83) | 2.35(2.19) | 5.09(4.65) |
Kidney infection | 324 | 4.43(3.97, 4.94) | 4.42(3.93, 4.97) | 2.12(1.96) | 4.36(3.97) |
Abscess | 307 | 5.3(4.73, 5.93) | 5.29(4.7, 5.95) | 2.38(2.21) | 5.2(4.73) |
Injection site urticaria | 262 | 3.02(2.68, 3.41) | 3.02(2.68, 3.4) | 1.58(1.41) | 2.99(2.7) |
Pharyngitis streptococcal | 239 | 5.92(5.21, 6.74) | 5.92(5.16, 6.79) | 2.53(2.35) | 5.79(5.2) |
Synovitis | 232 | 3.41(3, 3.89) | 3.41(2.97, 3.91) | 1.75(1.57) | 3.38(3.03) |
Pharyngitis | 213 | 4.61(4.03, 5.28) | 4.61(4.02, 5.29) | 2.18(1.99) | 4.54(4.05) |
Low birth weight baby | 212 | 6.81(5.94, 7.81) | 6.81(5.94, 7.81) | 2.73(2.53) | 6.64(5.92) |
Exposure via breast milk | 208 | 15.48(13.45, 17.81) | 15.46(13.48, 17.73) | 3.86(3.66) | 14.54(12.92) |
Product prescribing issue | 206 | 3.73(3.25, 4.29) | 3.73(3.25, 4.28) | 1.88(1.68) | 3.69(3.29) |
Fistula | 196 | 4.69(4.07, 5.41) | 4.69(4.09, 5.38) | 2.21(2) | 4.61(4.1) |
Sars-cov-2 test negative | 188 | 88.74(74.96, 105.05) | 88.67(74.33, 105.78) | 6(5.77) | 63.96(55.54) |
Basal cell carcinoma | 188 | 3.2(2.77, 3.7) | 3.2(2.79, 3.67) | 1.67(1.46) | 3.17(2.81) |
Tooth infection | 186 | 3.73(3.22, 4.31) | 3.72(3.24, 4.27) | 1.88(1.67) | 3.68(3.26) |
Pemphigus | 184 | 4.2(3.63, 4.86) | 4.2(3.66, 4.82) | 2.05(1.84) | 4.14(3.67) |
Hand deformity | 183 | 3.8(3.28, 4.39) | 3.79(3.3, 4.35) | 1.91(1.7) | 3.75(3.32) |
Axial spondyloarthritis | 177 | 113.69(94.9, 136.2) | 113.6(95.23, 135.52) | 6.25(6) | 75.92(65.27) |
Tonsillitis | 153 | 8(6.81, 9.41) | 8(6.84, 9.36) | 2.96(2.72) | 7.76(6.78) |
Oral candidiasis | 149 | 3.29(2.8, 3.87) | 3.29(2.81, 3.85) | 1.7(1.47) | 3.26(2.84) |
Skin infection | 141 | 3.43(2.91, 4.05) | 3.43(2.93, 4.01) | 1.76(1.52) | 3.39(2.95) |
Eye infection | 136 | 3.26(2.75, 3.86) | 3.26(2.73, 3.89) | 1.69(1.45) | 3.23(2.8) |
