Table 2 Signal strength of CZP AEs across System Organ Class (SOC) in the FAERS database.
From: A real-world pharmacovigilance study of Certolizumab pegol based on FAERS database
System organ class (SOC) | N. of events | ROR (95% CI) | PRR (95% CI) | IC (IC025) | EBGM(EBGM05) |
|---|---|---|---|---|---|
General disorders and administration site conditions | 47,258 | 1.24(1.23, 1.25) | 1.19(1.19, 1.19) | 0.24(0.23) | 1.18(1.17) |
Infections and infestations | 30,100 | 2.75(2.72, 2.79) | 2.51(2.46, 2.56) | 1.32(1.3) | 2.49(2.47) |
Injury, poisoning and procedural complications | 25,841 | 1.19(1.17, 1.2) | 1.17(1.15, 1.19) | 0.22(0.2) | 1.16(1.15) |
Musculoskeletal and connective tissue disorders | 24,449 | 2.17(2.14, 2.2) | 2.04(2, 2.08) | 1.02(1) | 2.03(2.01) |
Gastrointestinal disorders | 18,873 | 0.98(0.97, 0.99) | 0.98(0.96, 1) | -0.03(-0.05) | 0.98(0.97) |
Skin and subcutaneous tissue disorders | 15,076 | 1.24(1.22, 1.26) | 1.22(1.2, 1.24) | 0.29(0.27) | 1.22(1.2) |
Nervous system disorders | 10,124 | 0.51(0.5, 0.53) | 0.54(0.53, 0.55) | -0.89(-0.92) | 0.54(0.53) |
Respiratory, thoracic and mediastinal disorders | 7988 | 0.73(0.72, 0.75) | 0.74(0.73, 0.75) | -0.42(-0.46) | 0.74(0.73) |
Investigations | 7985 | 0.58(0.57, 0.59) | 0.6(0.59, 0.61) | -0.74(-0.77) | 0.6(0.59) |
Psychiatric disorders | 4085 | 0.31(0.3, 0.32) | 0.32(0.31, 0.33) | -1.62(-1.67) | 0.32(0.32) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 3424 | 0.55(0.53, 0.57) | 0.56(0.54, 0.58) | -0.84(-0.88) | 0.56(0.54) |
Pregnancy, puerperium and perinatal conditions | 3228 | 3.54(3.41, 3.66) | 3.5(3.37, 3.64) | 1.79(1.74) | 3.46(3.36) |
Eye disorders | 2573 | 0.56(0.54, 0.58) | 0.56(0.54, 0.58) | -0.82(-0.88) | 0.57(0.55) |
Immune system disorders | 2553 | 1(0.96, 1.04) | 1(0.96, 1.04) | 0(-0.06) | 1(0.97) |
Vascular disorders | 2400 | 0.5(0.48, 0.52) | 0.5(0.48, 0.52) | -0.99(-1.04) | 0.5(0.49) |
Cardiac disorders | 2127 | 0.37(0.36, 0.39) | 0.38(0.37, 0.4) | -1.39(-1.45) | 0.38(0.37) |
Metabolism and nutrition disorders | 2068 | 0.43(0.41, 0.44) | 0.43(0.41, 0.45) | -1.21(-1.27) | 0.43(0.42) |
Renal and urinary disorders | 1743 | 0.41(0.39, 0.43) | 0.42(0.4, 0.44) | -1.26(-1.32) | 0.42(0.4) |
Blood and lymphatic system disorders | 1247 | 0.32(0.31, 0.34) | 0.33(0.31, 0.35) | -1.6(-1.68) | 0.33(0.31) |
Hepatobiliary disorders | 1145 | 0.57(0.53, 0.6) | 0.57(0.54, 0.6) | -0.81(-0.89) | 0.57(0.54) |
Reproductive system and breast disorders | 959 | 0.52(0.49, 0.55) | 0.52(0.49, 0.55) | -0.94(-1.03) | 0.52(0.49) |
Ear and labyrinth disorders | 669 | 0.69(0.64, 0.74) | 0.69(0.64, 0.75) | -0.54(-0.64) | 0.69(0.65) |
Congenital, familial and genetic disorders | 348 | 0.5(0.45, 0.56) | 0.51(0.46, 0.56) | -0.98(-1.13) | 0.51(0.46) |
Endocrine disorders | 259 | 0.45(0.39, 0.5) | 0.45(0.4, 0.51) | -1.16(-1.33) | 0.45(0.4) |
