Table 2.
Signal strength of ixekizumab AEs across system organ classes (SOC) in the FAERS database.
| SOC | Case numbers | ROR(95%CI) | PRR(χ2) | EBGM(EBGM05) | IC(IC025) |
|---|---|---|---|---|---|
| Infections and infestations* | 6,712 | 2.42 (2.36–2.48) | 2.24 (4882.58) | 2.24 (2.19) | 1.16 (1.13) |
| General disorders and administration site conditions* | 19,940 | 2.66 (2.61–2.7) | 2.05 (13022.97) | 2.05 (2.02) | 1.03 (1.01) |
| Investigations | 1,188 | 0.36 (0.34–0.38) | 0.38 (1307.97) | 0.38 (0.36) | −1.41 (−1.5) |
| Respiratory, thoracic and mediastinal disorders | 1,379 | 0.53 (0.51–0.56) | 0.55 (543.34) | 0.55 (0.52) | −0.87 (−0.95) |
| Skin and subcutaneous tissue disorders* | 5,777 | 1.95 (1.89–2) | 1.85 (2367.2) | 1.84 (1.8) | 0.88 (0.84) |
| Gastrointestinal disorders | 3,419 | 0.74 (0.72–0.77) | 0.76 (288.82) | 0.76 (0.74) | −0.4 (−0.45) |
| Immune system disorders* | 818 | 1.23 (1.15–1.32) | 1.23 (34.21) | 1.22 (1.16) | 0.29 (0.19) |
| Blood and lymphatic system disorders | 206 | 0.22 (0.19–0.26) | 0.23 (554.33) | 0.23 (0.2) | −2.14 (−2.34) |
| Nervous system disorders | 1,696 | 0.38 (0.36–0.4) | 0.4 (1673.1) | 0.4 (0.38) | −1.33 (−1.4) |
| Musculoskeletal and connective tissue disorders | 2,341 | 0.83 (0.79–0.86) | 0.83 (81.44) | 0.83 (0.81) | −0.26 (−0.32) |
| Injury, poisoning and procedural complications | 4,771 | 0.75 (0.73–0.77) | 0.77 (371.3) | 0.77 (0.75) | −0.38 (−0.42) |
| Psychiatric disorders | 803 | 0.26 (0.25–0.28) | 0.27 (1623.52) | 0.28 (0.26) | −1.86 (−1.96) |
| Social circumstances | 85 | 0.34 (0.28–0.43) | 0.35 (105.63) | 0.35 (0.29) | −1.53(−1.84) |
| Eye disorders | 462 | 0.42 (0.38–0.46) | 0.43 (363.42) | 0.43 (0.4) | −1.23(−1.36) |
| Hepatobiliary disorders | 178 | 0.39 (0.34–0.45) | 0.39 (169.36) | 0.39 (0.35) | −1.35(−1.57) |
| Metabolism and nutrition disorders | 326 | 0.29 (0.26–0.32) | 0.29 (562.35) | 0.29 (0.27) | −1.76(−1.92) |
| Cardiac disorders | 437 | 0.38 (0.35–0.42) | 0.39 (430.78) | 0.39 (0.36) | −1.36 (−1.5) |
| Vascular disorders | 382 | 0.36 (0.32–0.4) | 0.36 (434.77) | 0.36 (0.33) | −1.46(−1.61) |
| Product issues | 303 | 0.3 (0.27–0.34) | 0.3 (489.36) | 0.31 (0.28) | −1.71(−1.88) |
| Surgical and medical procedures* | 1,834 | 2.39 (2.28–2.5) | 2.34 (1424.74) | 2.34 (2.25) | 1.22 (1.16) |
| Renal and urinary disorders | 342 | 0.31 (0.28–0.35) | 0.32 (510.66) | 0.32 (0.29) | −1.65(−1.81) |
| Reproductive system and breast disorders | 128 | 0.33 (0.28–0.39) | 0.33 (175.04) | 0.33 (0.29) | −1.6 (−1.85) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 753 | 0.44 (0.41–0.47) | 0.45 (531.47) | 0.45 (0.42) | −1.16(−1.27) |
| Ear and labyrinth disorders | 184 | 0.77 (0.67–0.89) | 0.77 (12.6) | 0.77 (0.68) | −0.38(−0.59) |
| Endocrine disorders | 25 | 0.17 (0.12–0.26) | 0.17 (98.06) | 0.17 (0.13) | −2.52(−3.09) |
| Congenital, familial and genetic disorders | 14 | 0.09 (0.06–0.16) | 0.09 (122.33) | 0.09 (0.06) | −3.41(−4.15) |
| Pregnancy, puerperium and perinatal conditions | 48 | 0.23 (0.17–0.3) | 0.23 (126.78) | 0.23 (0.18) | −2.14 (−2.55) |
Asterisks (*) indicate statistically significant signals in algorithm; ROR, reporting odds ratio; PRR, proportional reporting ratio; EBGM, empirical Bayesian geometric mean; EBGM05, the lower limit of the 95% CI of EBGM; IC, information component; IC025, the lower limit of the 95% CI of the IC; CI, confidence interval; AEs, adverse events.